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Archive for the ‘Regenerative Medicine’ Category

Regenerative Medicine Gets A Boost With Quick Printing Of 3D Microstructures

Monday, September 17th, 2012

September 16, 2012

Image Caption: NanoEngineering Professor Shaochen Chen has demonstrated the capability of printing three-dimensional blood vessels in mere seconds out of soft, biocompatible hydrogels. Being able to print blood vessels is essential to achieving the promise of regenerative medicine because it is how the body distributes oxygen and nutrients. Image Credit: Biomedical Nanotechnology Laboratory, Chen Research Group, UC San Diego Jacobs School of Engineering.

April Flowers for redOrbit.com Your Universe Online

Nanoengineers at the University of California, San Diego have created a new technology that has far-reaching implications for regenerative medicine. The results of the project have been reported in Advanced Materials.

The team has been able to fabricate, in seconds, microscale three-dimensional (3D) structures out of soft biocompatible hydrogels. This could lead to better systems for growing and studying cells, including stem cells, in the laboratory. In the long-term, the goal is to be able to print biological tissues for regenerative medicine. For example, repairing the damage caused by a heart attack by replacing it with tissue from a printer.

Professor Shaochen Chen developed this new biofabrication technology, called dynamic optical projection stereolithography (DOPsL). Current fabrication techniques, such as photolithography and micro-contact printing, are limited to generating simple geometries or 2D patterns. Stereolithography is best known for its ability to print large objects such as tools and car parts.

The difference between earlier stereolithography and DOPsL, Chen says, is in the micro- and nanoscale resolution required to print tissues that mimic natures fine-grained details, including blood vessels, which are essential for distributing nutrients and oxygen throughout the body. Without the ability to print vasculature, an engineered liver or kidney, for example, is useless in regenerative medicine. With DOPsL, Chens team was able to achieve more complex geometries common in nature such as flowers, spirals and hemispheres. Other current 3D fabrication techniques, such as two-photon photopolymerization, can take hours to fabricate a 3D part.

The system uses a computer projection system and precisely controlled micromirrors to shine light on a selected area of a solution containing photo-sensitive biopolymers and cells. This begins the solidification process, which forms one layer of solid structure at a time, but in a continuous fashion. The Obama administration in March launched a $1 billion investment in advanced manufacturing technologies, including creating the National Additive Manufacturing Innovation Institute with $30 million in federal funding to focus on 3D printing. The term additive manufacturing refers to the way 3D structures are built layering very thin materials.

The development of this new technology is part of a grant that Chen received from the National Institutes of Health (NIH). Chens research group focuses on fabrication of nanostructured biomaterials and nanophotonics for biomedical engineering.

Source: April Flowers for redOrbit.com - Your Universe Online

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Regenerative Medicine Gets A Boost With Quick Printing Of 3D Microstructures

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Two lessons I learned this week.

Sunday, September 16th, 2012
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I learned two valuable things this week I thought I'd pass on in a Friday afternoon post.  Actually strictly speaking these are likely things I've learned before but needed to re-learn or to be 'reminded' of their importance.
Please pardon a little stroll away from the typically strict focus on cell therapy -- but in a way that's the theme of today's post.
1.  Take time each week to read something from outside your specific profession or job focus.  
I'm not talking here about the importance of escaping in the evening with a fiction novel (also very important) but rather reading something professional but from well outside your area of focus.  Here are my examples.

I always read WIRED magazine.  Aside from GEN it's the only magazine I read.  Just reading something outside of cell therapy or biotech often infuses me with an idea that otherwise would have never occurred to me like the need for a cell therapy X Prize or cellular aggregates as microcarriers or tissue-engineered memory and processing devices or even just the conviction to better represent cell therapy to the broader world out there of scientists, engineers, journalists, policy-makers, or perhaps people with too much money looking to be inspired and wanting to make a difference.

Similarly, on a flight this week I reached into the seat pocket in front of me and discovered a recent copy of the Journal of the American Medical Association.  I read a fascinating article that has me excited about an idea for how we as a cell therapy industry might lead the way in addressing clinical trial and data transparency that would put our sector in a leadership position, lend the industry a much-needed spotlight, and has the potential to facilitate the kind of meta-analysis and data-mining that could only be done through data aggregation.  I believe the concept has the potential to be disproportionately significant for a sector defined by so many small, under-powered trials.
The idea may never see the light of day but the point is the source of the inspiration.  In order to 'think' outside the box one typically has to 'be' outside the box.  Lesson?  Spend some time outside your box.
2. It often takes something very small to make a disproportionately significant impact on someone.  
I was reminded recently through an exchange of simple kindnesses just how little it sometimes takes to make a big difference in someone's life.  For you what might be so easy to give might be of unparalleled value to someone for whom that is so unattainable.  
Lesson?  When the opportunity knocks for you to give something small or simple, take it.  This kind of charity almost always has the potential to be mre impactful than you might ever imagine.
http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Two lessons I learned this week.

Sunday, September 16th, 2012
Tweet 

I learned two valuable things this week I thought I'd pass on in a Friday afternoon post.  Actually strictly speaking these are likely things I've learned before but needed to re-learn or to be 'reminded' of their importance.
Please pardon a little stroll away from the typically strict focus on cell therapy -- but in a way that's the theme of today's post.
1.  Take time each week to read something from outside your specific profession or job focus.  
I'm not talking here about the importance of escaping in the evening with a fiction novel (also very important) but rather reading something professional but from well outside your area of focus.  Here are my examples.

I always read WIRED magazine.  Aside from GEN it's the only magazine I read.  Just reading something outside of cell therapy or biotech often infuses me with an idea that otherwise would have never occurred to me like the need for a cell therapy X Prize or cellular aggregates as microcarriers or tissue-engineered memory and processing devices or even just the conviction to better represent cell therapy to the broader world out there of scientists, engineers, journalists, policy-makers, or perhaps people with too much money looking to be inspired and wanting to make a difference.

Similarly, on a flight this week I reached into the seat pocket in front of me and discovered a recent copy of the Journal of the American Medical Association.  I read a fascinating article that has me excited about an idea for how we as a cell therapy industry might lead the way in addressing clinical trial and data transparency that would put our sector in a leadership position, lend the industry a much-needed spotlight, and has the potential to facilitate the kind of meta-analysis and data-mining that could only be done through data aggregation.  I believe the concept has the potential to be disproportionately significant for a sector defined by so many small, under-powered trials.
The idea may never see the light of day but the point is the source of the inspiration.  In order to 'think' outside the box one typically has to 'be' outside the box.  Lesson?  Spend some time outside your box.
2. It often takes something very small to make a disproportionately significant impact on someone.  
I was reminded recently through an exchange of simple kindnesses just how little it sometimes takes to make a big difference in someone's life.  For you what might be so easy to give might be of unparalleled value to someone for whom that is so unattainable.  
Lesson?  When the opportunity knocks for you to give something small or simple, take it.  This kind of charity almost always has the potential to be mre impactful than you might ever imagine.
http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Cytomedix's AutoloGel System Highlighted in Multiple Poster Presentations at the Symposium on Advanced Wound Care Fall …

Wednesday, September 12th, 2012

GAITHERSBURG, MD--(Marketwire - Sep 11, 2012) - Cytomedix, Inc. ( OTCQB : CMXI ), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that the Company's AutoloGel System will be highlighted in three poster presentations at the Symposium on Advanced Wound Care Fall 2012 ("SAWC Fall 2012") taking place September 12-14 at the Baltimore Convention Center.

The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel, and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management.

Posters will be showcased in the Poster Reception September 13 from 5:30 p.m. to 6:15 p.m. local time, and posters will be available for viewing September 12 and September 13 from 8:00 a.m. to 4:00 p.m. local time. The following posters highlighting Cytomedix's PRP technology will be presented at SAWC Fall 2012.

Cytomedix will host a booth at the Symposium for clinicians and other attendees to learn more about the AutoloGel System and the benefits it provides in the management of complex recalcitrant wounds. Cytomedix will be showcasing AutoloGel at Booth #1007 in the Exhibit Hall.

"SAWC Fall 2012 is the ideal venue to showcase our growing body of positive clinical data on AutoloGel as it is the premier educational wound care program and the largest annual gathering of wound care professionals in the U.S., with more than 1,000 physicians, podiatrists, nurses, therapists and researchers expected to attend," stated Martin P. Rosendale, Chief Executive Officer of Cytomedix. "These poster presentations underscore the robust nature of AutoloGel to advance the speed and progress to healing in a variety of recalcitrant wounds in a number of healthcare settings."

About The Association for the Advancement of Wound Care Since 1995 the Association for the Advancement of Wound Care ("AAWC") has been the leader in interdisciplinary wound healing and tissue preservation. It is a not-for-profit association headquartered in the U.S. open to everyone involved in wound care, including clinicians, patients and their lay caregivers, facilities, industry, students, retirees and other advocates interested in the care of wounds. AAWC spreads awareness by promoting excellence in education, clinical practice, public policy and research. Through numerous association benefits and activities, AAWC members have the opportunity to be part of a collaborative community that facilitates optimal care for those who suffer with wounds. This community encourages an equal partnership among all individuals who are involved in the care of patients.

For more information about the AAWC and member benefits, please visit http://www.aawconline.org.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor Statement Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's reimbursement related efforts, the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

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CIRM Funds Six UC San Diego Stem Cell Researchers

Saturday, September 8th, 2012

Newswise The governing board of the California Institute for Regenerative Medicine (CIRM) has announced that six investigators from the University of California, San Diego Stem Cell Research program have received a total of more than $7 million in the latest round of CIRM funding. This brings UC San Diegos total to more than $128 million in CIRM funding since the first awards in 2006.

UC San Diego scientists funded by the newly announced CIRM Basic Biology Awards IV include Maike Sander, MD, professor of Pediatrics and Cellular and Molecular Medicine; Miles Wilkinson, PhD, professor, Division of Reproductive Endocrinology; Gene Yeo, PhD, MBA, assistant professor with the Department of Cellular and Molecular Medicine and the Institute for Genomic Medicine; George L. Sen, PhD, assistant professor of cellular and molecular medicine; David Traver, PhD, associate professor with the Department of Cellular and Molecular Medicine and Ananda Goldrath, PhD, associate professor in the Division of Biological Sciences.

Sander was awarded nearly $1.4 million for her proposal to define and characterize the key transcription factors necessary to promote maturation of human embryonic stem cell (hESC)-derived pancreatic progenitors into mature insulin-secreting beta cells. The loss of pancreatic beta cells in type 1 diabetes results in the absence of insulin secreted by the pancreas. The goal of this work is to enable scientists to one day produce an unlimited source of transplantable beta-cells for patients with diabetes.

Wilkinsons grant of $1.36 million will allow his lab to develop and test induced pluripotent stem cells (iPS cells) from patients with genetic mutations in a component of the pathway that results in intellectual disabilities. Many of these patients also have autism, attention-deficit disorders or schizophrenia. Directed towards understanding fundamental mechanisms by which all stem cells are maintained, his research has the potential to impact non-psychiatric disorders as well.

A grant of almost $1.4 million will fund Yeos research to help decode the mechanisms that underlie the single most frequent genetic mutation found to contribute to neurodegenerative diseases amyotrophic lateral sclerosis (ALS or Lou Gehrigs disease) and frontotemporal dementia (FTD). Yeo will generate iPSCs and differentiated motor neurons derived from patients with these mutations, then use genome-wide technologies to analyze these and normal cells and test strategies to rescue mutation-induced defects in iPSC-derived motor neurons.

Sen received a grant of just over $1 million to investigate how tissue specific stem and progenitor cells exist to replenish both healthy, normal tissue and for regeneration from a wound. Disease and aging deplete stem and progenitor cells, impeding the bodys ability to regenerate itself. Sens work aims to better understand the mechanisms of self-renewal and differentiation in epidermal (skin) stem cells. Imbalanced growth and differentiation of epidermal cells can lead to a variety of human skin disorders, including psoriasis and cancer.

Traver, who was awarded a CIRM grant of more than $1.3 million in collaboration with Thierry Jaffredo of the Universit Pierre et Marie Curie in Paris, studies hematopoietic stem cells. HSCs are rare, multipotent stem cells that give rise to all blood cell types, including red blood and immune cells. Travers lab investigates the genes and signaling pathways used by vertebrate embryos to create the first HSCs. An understanding of this developmental process has implications for producing restorative stem cell-based therapies for diseases like leukemia and congenital blood disorders. Currently, medical treatments using HSCs are hampered by cell shortages and finding compatible matches between donors and recipients.

Goldraths $1.16 million grant will help develop strategies to induce immunological tolerance to hESC-derived tissues and cells. Immune-mediated rejection of hESC-derived tissues remains a significant barrier to the promise of regenerative therapies. She proposes a novel approach to promote long-term acceptance of hESC-derived tissues by exploring the molecular pathways and immune cell types that mediate the induction of immune tolerance and pursuing additional targets that halt rejection of tissue grafts derived from these stem cells. If successful, this would increase the potential reach of cellular therapies by decreasing the undesirable side effects of generalized immune suppression.

The CIRM Basic Biology Awards are designed to fund investigations into the basic mechanisms underlying stem cell biology, cellular plasticity, and cellular differentiation. These awards will also fund the development and use human stem cell based models for exploring disease. According to CIRM, studies supported by these awards will form the foundation for future translational and clinical advances, enabling the realization of the full potential of human stem cells and reprogrammed cells for therapies and as tools for biomedical innovation.

CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for stem cell research at California universities and research institutions and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities.

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StemCells, Inc. Awarded $20 Million From the California Institute for Regenerative Medicine for Alzheimer's Disease …

Friday, September 7th, 2012

NEWARK, Calif., Sept. 6, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the California Institute for Regenerative Medicine (CIRM) has approved an award to the Company for up to $20 million under CIRM's Disease Team Therapy Development Award program (RFA 10-05). The award is to fund preclinical development of StemCells' proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) in Alzheimer's disease over a maximum four-year period, with the goal of filing an investigational new drug (IND) application for a clinical trial in that time. In July, CIRM approved a separate award to the Company under RFA 10-05 for up to $20 million to fund preclinical development of HuCNS-SC cells in cervical spinal cord injury.

"With the recent spate of late-stage clinical failures in Alzheimer's disease, it is clear that the field could benefit from alternative approaches to lessen the huge burden on families, caregivers and our healthcare system," commented Martin McGlynn, President and CEO of StemCells, Inc. "Our recently reported preclinical data, which showed that our neural stem cells restored memory and enhanced synaptic function in two animal models relevant to Alzheimer's disease, shows our approach has promise. We greatly appreciate the support from CIRM, which should help us accelerate our efforts to test our HuCNS-SC cells in Alzheimer's disease."

StemCells will evaluate its HuCNS-SC cells as a potential treatment for Alzheimer's disease in collaboration with Frank LaFerla, Ph.D., a world-renowned researcher in the field. Dr. LaFerla is Director of the University of California, Irvine (UCI) Institute for Memory Impairments and Neurological Disorders (UCI MIND), and Chancellor's Professor, Neurobiology and Behavior in the School of Biological Sciences at UCI.

Mr. McGlynn added, "CIRM's approval of two awards to StemCells illustrates the tremendous promise of our neural stem cell technology and the high degree of confidence in the world class team of scientists and clinicians who will be working to translate this technology into potential treatments and cures for these devastating diseases."

About CIRM

CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and recently reported positive interim data for the first patient cohort. The Company has also initiated a Phase I/II clinical trial in dry age-related macular degeneration (AMD), and is pursuing preclinical studies in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand. Further information about StemCells is available at http://www.stemcellsinc.com.

The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding; the potential of the Company's HuCNS-SC cells to treat a broad range of central nervous system disorders such as Alzheimer's disease and spinal cord injury; the prospect of initiating a clinical trial in Alzheimer's disease or cervical spinal cord injury; the timing and prospects for funding by the California Institute for Regenerative Medicine; and the future business operations of the Company, including its ability to conduct clinical trials as well as its other research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the results of the Company's preclinical studies will be replicated in humans; uncertainties about the prospect and timing of entering into the agreements necessary to receive funding from CIRM and whether the Company will satisfy, and continue to satisfy, all preconditions for such funding; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2011, and in its subsequent reports on Forms 10-Q and 8-K.

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Cytomedix's AutoloGel System Highlighted in Two Presentations at the 4th Congress of the World Union of Wound Healing …

Thursday, September 6th, 2012

GAITHERSBURG, MD--(Marketwire -09/05/12)- Cytomedix, Inc. (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Company's AutoloGel System will be highlighted in an oral abstract and a poster presentation at the 4th Congress of the World Union of Wound Healing Societies (WUWHS 2012) being held from September 2-6, in Yokohama, Japan.

The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel, and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management.

"The Impact of Autologous Platelet Rich Plasma (PRP) Gel on Chronic Wounds" will be presented September 5th from 3:00 to 4:30 p.m. JST as part of the Tissue Engineering and Regenerative Medicines in Wound Healing session. The poster, OR 206, will be presented by Laura Parnell, MSc, CWS, Precision Consulting on behalf of Carelyn P. Fylling, RN, MSN, CWS, CLNC, Vice President of Professional Services of Cytomedix and lead author on the poster.

Key Study Findings (all data reflects mean outcomes)

The study concluded that AutoloGel PRP Gel "initiated rapid size reduction in long-standing non-healing wounds of multiple etiologies in multiple health care sites even in patients with compromised status."

In addition, Dr. Chugo Rinoie, DPM, ABPO, CWS, Chief of Podiatric Surgery, Wound Healing Center, Methodist Hospital of Southern California, Arcadia, Calif., and Medical Director, Millennia Wound Management, Inc., Los Angeles, will present Poster 125, entitled "Healing Complex, Severe Diabetic and Ischemic Wounds in Japan Using Platelet-Rich Plasma Gel" in the Exhibit Hall as part of the Diabetic Foot, Critical Limb Ischemia and Foot Care session.

"We are honored to have these two presentations of positive data in support of the use of AutoloGel to accelerate wound healing in a variety of chronic wounds selected for presentation at WUWHS 2012, as more than 1,200 abstracts were submitted for inclusion at this prestigious international Congress," noted Martin P. Rosendale, Chief Executive Officer of Cytomedix. "The data from these studies support and validate previous studies showing that AutoloGel significantly and reliably improves the rate of healing, speed and progress to healing as compared with previous experience with standard wound care alone. The complexity and co-morbidities associated with the wounds treated in these studies would have excluded them from any randomized controlled trial, making the findings from these real-world studies even more compelling."

"We believe we will continue to generate data such as these through the comprehensive collection of evidence we are undertaking through the Centers for Medicare and Medicaid Services' Coverage with Evidence Development program. We are confident such data will continue to strongly support the ongoing coverage for autologous PRP gel for the benefit of the various stakeholders in improving clinical wound care outcomes while lowering overall costs," added Mr. Rosendale.

About the Congress of the World Union of Wound Healing SocietyThe Congress of the World Union of Wound Healing Societies is held once every four years and provides an international forum for announcement of the latest research relating to wound healing that draws between 3,500 to 5,000 clinicians, researchers and professionals who serve the wound care markets around the world. The Congress also helps to ensure the exchange of information, the improvement and development of education, international person-to-person support and the promotion of industrial collaboration. The ultimate aim is to develop the field of wound healing. Despite the fact that "wounds" are a fundamental component and important target for surgery, there are still many factors that have yet to be clarified or fully understood.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

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ACT’s Chief Scientific Officer Dr. Robert Lanza to Deliver Opening Keynote Address at 4th Annual Stem Cell Symposium …

Tuesday, September 4th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its chief scientific officer, Robert Lanza, M.D., will be delivering the opening Keynote Speech at the 4th Annual Stem Cell Symposium 2012, being held in Singapore, September 6-7. Dr. Lanzas presentation is titled Pluripotent Stem Cells From Benchtop to Clinic.

With the theme, Stem Cell Based Therapy, the symposium will have a particular focus on clinical trials and industrial application of stem cells. Sponsored by Stem Cell Society of Singapore (SCSS), the conference will include scientific presentations from key contributors from academic, clinical, and commercial organizations who are translating basic research on stem cells into therapeutics, with a focus on applying engineering technologies to provide medical solutions.

In their opening statement, the organizers state, We are all keeping our fingers crossed for ACTs success, which will also bring a big boost to the stem cell community.

Other topics of the conference include human induced pluripotent stem cells (hiPSCs), drug screening, adult and cancer stem cells, and stem cell therapies emerging from Asia, with presentations from Indian, Korean and Japanese regenerative medicine companies. There will also be a joint session with the International Society for Cellular Therapy (ISCT) covering important issues concerning the commercialization of stem cells, and addressing issues such as reimbursement, manufacturing, characterization, and clinical implementation issues unique to cell therapies.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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Cytomedix's AutoloGel System Featured in Continuing Education Program at the Paralyzed Veterans of America Summit 2012

Tuesday, September 4th, 2012

GAITHERSBURG, MD--(Marketwire -09/04/12)- Cytomedix, Inc. (CMXI) (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that the Company's AutoloGel System was highlighted in a continuing education program at the Paralyzed Veterans of America Summit 2012 held August 28 to 30 at the Paris Las Vegas Hotel.

The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel, and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management.

The program, titled, "Platelet Rich Plasma (PRP) Gel for Wounds on Persons with SCI," was delivered by Laurie Rappl, PT, DPT, CWS, Clinical Development Liaison for Cytomedix. Ms. Rappl's discussion addressed the underlying mechanisms of action that allow the Company's physiologically relevant concentration of PRP in the AutoloGel System to accelerate healing in recalcitrant wounds in patients with Spinal Cord Injuries ("SCI"), and highlighted the clinical data demonstrating rapid reduction in wound area and volume, as well as reduction of undermining and sinus tracts/tunnels in non-healing wounds in patients with SCI.

"The physiology of SCI -- such as decreased blood flow, blood pressure and blood supply -- causes impairment at every step of the wound healing process. A physiologically relevant concentration of PRP has been shown to improve healing in even the hardest to treat chronic wounds in SCI patients," noted Ms. Rappl.

"It is especially rewarding for Cytomedix to have a continuing education program highlighting the benefits of the AutoloGel System for the treatment of chronic wounds in SCI patients. Pressure ulcers and other chronic wounds are persistent medical challenges that compromise the health and quality-of-life for these paralyzed patients," stated Martin P. Rosendale, Chief Executive Officer of Cytomedix. "Our clinical data demonstrates how the AutoloGel System's physiologically relevant concentration of PRP can rapidly restart the healing process in complex and chronic wounds, including wounds that were recalcitrant to other treatments."

About The Paralyzed Veterans of America SummitParalyzed Veterans' Summit 2012 + EXPO brings together more than 700 healthcare professionals in SCI and multiple sclerosis (MS) care. Doctors, nurses, occupational therapists, physical therapist, social workers and researchers convene to explore and implement holistic strategies to strengthen the continuum of care for SCI and MS patients.

The Paralyzed Veterans of America Summit serves as an educational venue bringing together professionals representing the full spectrum of SCI and MS healthcare and to support clinicians in their pursuit of maintaining their specialty certification and/or license to practice. The objectives are to enhance multi-specialty care across the lifespan of individuals with SCI and MS; to assess advances in the delivery of healthcare services; to present innovative models of care management; to improve practice skills of clinicians, surgeons, researchers and administrators; to discuss evidence-based medicine; to increase the body of knowledge on spinal cord injury and multiple sclerosis, their medical complications and consequences; to promote educational opportunities; to identify research priorities; and to present data on new developments in assessment and treatment.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor StatementStatements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's reimbursement related efforts, the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix's AutoloGel System Featured in Continuing Education Program at the Paralyzed Veterans of America Summit 2012

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Are some cell counts too good to be true? Why some companies’ product data may mislead.

Sunday, September 2nd, 2012
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This is a cautionary tale about the need for robust product characterization and release specifications for all cell therapy products.
Background
While our food often has a list of ingredients, our drugs don't.  We rely on our regulatory agencies to rule on the safety of our drugs.  These agencies require drug manufacturers to submit to them the composition of their therapeutic compounds and then to comply with the product specifications.  It is this composition and these specifications which formed the basis of the clinical data evaluated by the agency and upon which the marketing approval is based.  Any deviation from those specifications requires a submission to the regulatory agency for review. Any deviation without such a submission is punishable.   
At the manufacturing site, as products come off the line they are subjected to a panel of product release tests to ensure each batch complies with the product specifications.
Specification compliance is a direct function of the consistency of the raw and ancillary materials, equipment, and operating procedures used in the manufacturing process.



Cell therapies present unique challenges when complying with this paradigm for several reasons only two of which I will mention here.  Firstly, it is not possible to achieve the level of product purification as one might with other therapeutic products.  Secondly, the product characterization is at a cellular rather than molecular level.

Autologous cell therapies present another set of unique challenge in this paradigm because of the notable patient-to-patient variability where the patient is also the donor of the raw material.  This often means there is a wider tolerance of heterogeneity in the product but it still must be within what has been proven to the regulatory agency as a safe and effective range.  


In cases where an autologous cell therapy is centrally manufactured, they are most often subjected to product release testing similar to that described above.  One notable difference, particularly for fresh products, is that the products may be shipped to the clinic and even administered before the full panel of test results are obtained.  This wold be considered highly unusual (if ever acceptable) with other types of products but is tolerated because of the time-sensitivity of these products and their high safety profile.


In the case of autologous cell therapy products produced at the bedside there is often not the same kind of product release discipline.  Often the regulatory agencies deal with the product consistency and specification compliance issue by ensuring that the cell processing device used point-of-care is validated to ensure the cellular product output is always within a specified range shown to be clinically safe and effective.


The Varying Degree of Product Characterization/Specification of Autologous GTP Cell Therapy Products


However - and now I get to the point of this blog post - for cell-based products, procedures and/or devices/kits which are not mandated to be formally approved by a regulatory agency before they can be commercially marketed, there is no product specification rigor.  Compliance with the Good Tissue Practice regulations and guidance is deemed to ensure safety.  In the United States, cell-based products which are deemed to be "minimally manipulated" and intended for "homologous use" are typically allowed to go straight to market with no formal approval.  Safety and clinical data is not required but is practically necessary to support physician adoption and, where applicable, reimbursement.  


This means that for these products there is a great deal of variability in terms of how much rigor companies apply in characterizing their product and then ensuring that each batch complies with the specifications they themselves have determined to be safe and effective. Again, where such products are manufactured in a centralized facility the likelihood of some release testing is greater.  However, those companies relying on a point-of-care processing kit or device business model that has not been deemed to require formal market approval, rarely (if ever) include product release testing.


The common criticism of these companies is that they simply do not know what they are injecting into patients because of the combination of the patient-to-patient donor variability, the lack of any disciplined product characterization or dosing studies, and the absence of any product release testing.  


This criticism is not equally levied at all autologous GTP products or companies - even those relying on point-of-care processing.  Of course some companies care and do a lot to try to ensure their product is well-characterized and that each batch complies with product specifications. This may involve the use of product release tests but can also involve the combination of pre-market research into the product characterization, safety, and dosing along with validation of the device/kit output.  In this way a company can say that within a very small margin, the output will be within the product specifications the company knows is safe and efficacious.


However, in a rush to get their device/kit to market some companies appear to care very little about the cell product characterization, validation of the output of their device/kit, or tying this data to optimal dose.


More concerning are those companies that appear to provide such data but it is wrong or meaningless.  What follows appears to potentially be a case study of precisely this problem. 


The INCELL Study 


This week I came across a fascinating white paper from Incell Corporation analyzing the output of adipose tissue processing kits of MediVet-America apparently demonstrating the inaccuracy of their cell counts (a common type of cell therapy product characterization) and calling into the question the cell count claims of Intellicell Biosciences (New York, NY) and Adistem (Hong Kong).


At the heart of the critique is the claim that the cell counting (product characterization) techniques employed by these companies counts as cells things (namely acellular micelles) which are not cells.

I encourage you to read the white paper in its entirety.  They corresponding author told me to watch for one or more papers which they are preparing for submission to peer-reviewed publications shortly.  Presumably these will rely on a larger data set and perhaps test other methodologies or technologies.


For the purposes of this blog, I've pulled what I believe are the most salient excerpts below:

Intrigued by the high cell numbers  (5 to 20 million cells/gram)  reported by kit/device manufacturers such as MediVet-America (Lexington, KY), Intellicell  Biosciences (New York, NY), and Adistem, Ltd. (Hong Kong) in adipose stem cell therapy compared to other methods (e.g., 
Chung,Vidal, and Yoshimura), INCELL staff conducted a research study to  investigate the high apparent yield of stem cells.  This initial work was focused  on SVF cells from the MediVet Kit, which is marketed to isolate adiposederived canine SVF and stem cells.

The cell yields reported for the Medivet Kits are five to more than ten times higher than the yields routinely obtained by INCELL from freshly harvested human or animal adipose tissue using our adipose tissue processing methods.  These yields are also tenfold or higher than those reported in the literature by most academic researchers (Chung-canine, Vidal–equine, Yoshimura–human).  Since these  cell counts are used to support stem cell dosing recommendations and cell banking, it is important to better understand why the cell numbers are higher.

...

A comparative analytical study of three dog donors of adipose tissue was designed to evaluate the cell yields using the MediVet Kit as an example of this class of isolation system. All  kit procedures were followed as per the instructions provided.  A brief overview of the different cell counting methods used, and the resultant cell counts, observations and explanations of the results observed, are described below

....

This study shows that incorrect counting of adipose derived SVF cells and the subset of regenerative stem cells can subsequently result in inaccurate dosing, both in direct therapeutic applications and in cryostorage of cells for future use.  The DAPI-hemocytometer cell count (manual) was considered the most accurate, but there are various sources of technical difficulties that  can lead to incorrect  cell numbers. The nature of adipose tissue itself with variability in dissociation by enzymatic digestion can all contribute to the outcomes. Fat tissue has a propensity to form acellular micelles and oils upon tissue disruption. Processing methods or reagents (e.g., Solution E or lecithins) can generate micelles that may be  erroneously  counted as cells. Autofluorescence and dye trapping or uptake by the micelles can lead to very high inaccurate cell counts when automated cell counting is used. 


In this study the most inaccurate counting came from the Cellometer. When used according to kitrecommended guidelines and on-site training provided by Nexelcom for counting  cells by the MediVet procedure, the Cellometer overstated the DAPI-hemocytometer cell count by up to 20X or more. The Coulter Counter protocols also led to incorrect, high cell numbers. Although the cell counts were still a bit high, the authors recommend the NucleoCounter, or similar equipment, as more acceptable for automated counting.  The manual hemocytometer-DAPI method is the most accurate, but requires a highly experienced cell biologist or technician to make accurate counts and  is not suitable for routine clinical use. 

...

Other companies also have claims of very high cell numbers when their processes are used. Adistem, like MediVet, states they add an emulsifying agent to their kits to assist in cell release, and they also use a light activation system. Their kits were not tested in this study but it is possible that the high cell numbers reported by Adistem are also incorrect and result from the same problems highlighted in this paper for the MediVet procedure. Ultrasonic energy, which is commonly used to manufacture micellular  liposome  structures and to disrupt and lyse cells, is  another potentially problematic procedure for counting and verifying viable, regenerative cells.  Intellicell 3uses ultrasonic energy to release cells from adipose tissue, and it is possible that resultant micelles or cell fragments contribute to the higher than expected cell numbers.  This assumption could be verified with additional studies.  

In summary, the authors caution that great care must be taken when using kits and automated cell counting for stem cell dosing and cryobanking of cells intended for clinical use. Overestimated  cell numbers would be a major confounding source of variation when efficacy of stem cells injected are compared as doses based on cell number and when cryostored cells are aliquoted for use based on 

specific cell numbers as a treatment dose.  Hopefully, this study will lead to more  reproducible counting and processing methods being reported in the literature, more inter-study comparability of cell doses to clinical outcomes,  more industry diligence to support claims, and more accurate counting for dosing stem cell therapies to patients.

...

Chung D, Hayashi K, Toupadakis A, et al.  Osteogenic proliferation and differentiation of canine bone marrow and adipose tissue derived mesenchymal stromal cells and the influence of hypoxia.  Res Vet Sci, 2010; 92(1):66-75. Vidal MA, Kilroy GE, Lopez MJ, Johnson JR, Moore RM, Gimble JM. Characterization of equine adipose tissue-derived stromal cells: adipogenic and osteogenic capacity and comparison with bone marrow-derived mesenchymal stromal cells. Vet Surg, 2007; 36:613–622.  Yoshimura K, Shigeura T, Matsumoto D, et al:  Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirate.  J Cell Phys, 2006; 205:64-76.

 In Conclusion

Despite some of their other challenges, Intellicell, MediVet-America, and AdiStem (and others) have scored credibility points with some of my colleagues who have been impressed by the fact that they have incorporated product release criterion and testing technologies into their business model where their peer companies have not bothered.  This credibility may be quickly eroded if it turns out the results of their cell counts have been misleading.  For now it is a word of caution to do your own due diligence and/or not to fall into a similar product development/characterization trap.  Meanwhile, we will watch for the peer-reviewed papers.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Are some cell counts too good to be true? Why some companies’ product data may mislead.

Sunday, September 2nd, 2012
Tweet 

This is a cautionary tale about the need for robust product characterization and release specifications for all cell therapy products.
Background
While our food often has a list of ingredients, our drugs don't.  We rely on our regulatory agencies to rule on the safety of our drugs.  These agencies require drug manufacturers to submit to them the composition of their therapeutic compounds and then to comply with the product specifications.  It is this composition and these specifications which formed the basis of the clinical data evaluated by the agency and upon which the marketing approval is based.  Any deviation from those specifications requires a submission to the regulatory agency for review. Any deviation without such a submission is punishable.   
At the manufacturing site, as products come off the line they are subjected to a panel of product release tests to ensure each batch complies with the product specifications.
Specification compliance is a direct function of the consistency of the raw and ancillary materials, equipment, and operating procedures used in the manufacturing process.



Cell therapies present unique challenges when complying with this paradigm for several reasons only two of which I will mention here.  Firstly, it is not possible to achieve the level of product purification as one might with other therapeutic products.  Secondly, the product characterization is at a cellular rather than molecular level.

Autologous cell therapies present another set of unique challenge in this paradigm because of the notable patient-to-patient variability where the patient is also the donor of the raw material.  This often means there is a wider tolerance of heterogeneity in the product but it still must be within what has been proven to the regulatory agency as a safe and effective range.  


In cases where an autologous cell therapy is centrally manufactured, they are most often subjected to product release testing similar to that described above.  One notable difference, particularly for fresh products, is that the products may be shipped to the clinic and even administered before the full panel of test results are obtained.  This wold be considered highly unusual (if ever acceptable) with other types of products but is tolerated because of the time-sensitivity of these products and their high safety profile.


In the case of autologous cell therapy products produced at the bedside there is often not the same kind of product release discipline.  Often the regulatory agencies deal with the product consistency and specification compliance issue by ensuring that the cell processing device used point-of-care is validated to ensure the cellular product output is always within a specified range shown to be clinically safe and effective.


The Varying Degree of Product Characterization/Specification of Autologous GTP Cell Therapy Products


However - and now I get to the point of this blog post - for cell-based products, procedures and/or devices/kits which are not mandated to be formally approved by a regulatory agency before they can be commercially marketed, there is no product specification rigor.  Compliance with the Good Tissue Practice regulations and guidance is deemed to ensure safety.  In the United States, cell-based products which are deemed to be "minimally manipulated" and intended for "homologous use" are typically allowed to go straight to market with no formal approval.  Safety and clinical data is not required but is practically necessary to support physician adoption and, where applicable, reimbursement.  


This means that for these products there is a great deal of variability in terms of how much rigor companies apply in characterizing their product and then ensuring that each batch complies with the specifications they themselves have determined to be safe and effective. Again, where such products are manufactured in a centralized facility the likelihood of some release testing is greater.  However, those companies relying on a point-of-care processing kit or device business model that has not been deemed to require formal market approval, rarely (if ever) include product release testing.


The common criticism of these companies is that they simply do not know what they are injecting into patients because of the combination of the patient-to-patient donor variability, the lack of any disciplined product characterization or dosing studies, and the absence of any product release testing.  


This criticism is not equally levied at all autologous GTP products or companies - even those relying on point-of-care processing.  Of course some companies care and do a lot to try to ensure their product is well-characterized and that each batch complies with product specifications. This may involve the use of product release tests but can also involve the combination of pre-market research into the product characterization, safety, and dosing along with validation of the device/kit output.  In this way a company can say that within a very small margin, the output will be within the product specifications the company knows is safe and efficacious.


However, in a rush to get their device/kit to market some companies appear to care very little about the cell product characterization, validation of the output of their device/kit, or tying this data to optimal dose.


More concerning are those companies that appear to provide such data but it is wrong or meaningless.  What follows appears to potentially be a case study of precisely this problem. 


The INCELL Study 


This week I came across a fascinating white paper from Incell Corporation analyzing the output of adipose tissue processing kits of MediVet-America apparently demonstrating the inaccuracy of their cell counts (a common type of cell therapy product characterization) and calling into the question the cell count claims of Intellicell Biosciences (New York, NY) and Adistem (Hong Kong).


At the heart of the critique is the claim that the cell counting (product characterization) techniques employed by these companies counts as cells things (namely acellular micelles) which are not cells.

I encourage you to read the white paper in its entirety.  They corresponding author told me to watch for one or more papers which they are preparing for submission to peer-reviewed publications shortly.  Presumably these will rely on a larger data set and perhaps test other methodologies or technologies.


For the purposes of this blog, I've pulled what I believe are the most salient excerpts below:

Intrigued by the high cell numbers  (5 to 20 million cells/gram)  reported by kit/device manufacturers such as MediVet-America (Lexington, KY), Intellicell  Biosciences (New York, NY), and Adistem, Ltd. (Hong Kong) in adipose stem cell therapy compared to other methods (e.g., 
Chung,Vidal, and Yoshimura), INCELL staff conducted a research study to  investigate the high apparent yield of stem cells.  This initial work was focused  on SVF cells from the MediVet Kit, which is marketed to isolate adiposederived canine SVF and stem cells.

The cell yields reported for the Medivet Kits are five to more than ten times higher than the yields routinely obtained by INCELL from freshly harvested human or animal adipose tissue using our adipose tissue processing methods.  These yields are also tenfold or higher than those reported in the literature by most academic researchers (Chung-canine, Vidal–equine, Yoshimura–human).  Since these  cell counts are used to support stem cell dosing recommendations and cell banking, it is important to better understand why the cell numbers are higher.

...

A comparative analytical study of three dog donors of adipose tissue was designed to evaluate the cell yields using the MediVet Kit as an example of this class of isolation system. All  kit procedures were followed as per the instructions provided.  A brief overview of the different cell counting methods used, and the resultant cell counts, observations and explanations of the results observed, are described below

....

This study shows that incorrect counting of adipose derived SVF cells and the subset of regenerative stem cells can subsequently result in inaccurate dosing, both in direct therapeutic applications and in cryostorage of cells for future use.  The DAPI-hemocytometer cell count (manual) was considered the most accurate, but there are various sources of technical difficulties that  can lead to incorrect  cell numbers. The nature of adipose tissue itself with variability in dissociation by enzymatic digestion can all contribute to the outcomes. Fat tissue has a propensity to form acellular micelles and oils upon tissue disruption. Processing methods or reagents (e.g., Solution E or lecithins) can generate micelles that may be  erroneously  counted as cells. Autofluorescence and dye trapping or uptake by the micelles can lead to very high inaccurate cell counts when automated cell counting is used. 


In this study the most inaccurate counting came from the Cellometer. When used according to kitrecommended guidelines and on-site training provided by Nexelcom for counting  cells by the MediVet procedure, the Cellometer overstated the DAPI-hemocytometer cell count by up to 20X or more. The Coulter Counter protocols also led to incorrect, high cell numbers. Although the cell counts were still a bit high, the authors recommend the NucleoCounter, or similar equipment, as more acceptable for automated counting.  The manual hemocytometer-DAPI method is the most accurate, but requires a highly experienced cell biologist or technician to make accurate counts and  is not suitable for routine clinical use. 

...

Other companies also have claims of very high cell numbers when their processes are used. Adistem, like MediVet, states they add an emulsifying agent to their kits to assist in cell release, and they also use a light activation system. Their kits were not tested in this study but it is possible that the high cell numbers reported by Adistem are also incorrect and result from the same problems highlighted in this paper for the MediVet procedure. Ultrasonic energy, which is commonly used to manufacture micellular  liposome  structures and to disrupt and lyse cells, is  another potentially problematic procedure for counting and verifying viable, regenerative cells.  Intellicell 3uses ultrasonic energy to release cells from adipose tissue, and it is possible that resultant micelles or cell fragments contribute to the higher than expected cell numbers.  This assumption could be verified with additional studies.  

In summary, the authors caution that great care must be taken when using kits and automated cell counting for stem cell dosing and cryobanking of cells intended for clinical use. Overestimated  cell numbers would be a major confounding source of variation when efficacy of stem cells injected are compared as doses based on cell number and when cryostored cells are aliquoted for use based on 

specific cell numbers as a treatment dose.  Hopefully, this study will lead to more  reproducible counting and processing methods being reported in the literature, more inter-study comparability of cell doses to clinical outcomes,  more industry diligence to support claims, and more accurate counting for dosing stem cell therapies to patients.

...

Chung D, Hayashi K, Toupadakis A, et al.  Osteogenic proliferation and differentiation of canine bone marrow and adipose tissue derived mesenchymal stromal cells and the influence of hypoxia.  Res Vet Sci, 2010; 92(1):66-75. Vidal MA, Kilroy GE, Lopez MJ, Johnson JR, Moore RM, Gimble JM. Characterization of equine adipose tissue-derived stromal cells: adipogenic and osteogenic capacity and comparison with bone marrow-derived mesenchymal stromal cells. Vet Surg, 2007; 36:613–622.  Yoshimura K, Shigeura T, Matsumoto D, et al:  Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirate.  J Cell Phys, 2006; 205:64-76.

 In Conclusion

Despite some of their other challenges, Intellicell, MediVet-America, and AdiStem (and others) have scored credibility points with some of my colleagues who have been impressed by the fact that they have incorporated product release criterion and testing technologies into their business model where their peer companies have not bothered.  This credibility may be quickly eroded if it turns out the results of their cell counts have been misleading.  For now it is a word of caution to do your own due diligence and/or not to fall into a similar product development/characterization trap.  Meanwhile, we will watch for the peer-reviewed papers.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Biostem U.S., Corporation Opens National Affiliate Program for The Biostem Method(TM) of Hair Regrowth Treatments

Tuesday, August 28th, 2012

CLEARWATER, FL--(Marketwire -08/28/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, The Company), a fully reporting public company in the stem cell regenerative medicine sector, announced today that, in response to overwhelming inquiries from hair clinics around the nation, it has completed preparation to allow for expansion of hair regrowth services throughout the United States.

According to Dwight Brunoehler, Chief Executive Officer of Bisotem, "On the heels of Dr. Marina Pizarro's initial hair replacement procedures using The Biostem Method, the Company is now fully prepared to offer and support turnkey operations that will provide its proprietary hair regrowth technology to qualified physicians and clinics in the U.S. This service provides equipment, on site set up, training, operational protocols, marketing assistance, a fully staffed training facility, and on-going support. Our intention is to make this as easy as possible for affiliates to become involved. After entering into an agreement, physicians will be able to offer Biostem services in their offices within 8 weeks. It is expected that hair replacement clinics in New York, California, Texas and other metropolitan centers known for the popularity of cosmetic procedures will be on board The Biostem Method before the end of the year."

Biostem U.S., Corporation has developed a hair restoration process known as The Biostem Method. This process, offered through Biostem affiliates and licensees, involves the use of platelet rich plasma injections, low level laser therapy, nutraceutical supplements to stimulate stem cell growth, and private labeled hair products. This combination has proven highly effective in restoring hair growth in men and women.

About Biostem U.S., CorporationBiostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair regrowth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group, 310-974-6821.

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Biostem U.S., Corporation Opens National Affiliate Program for The Biostem Method(TM) of Hair Regrowth Treatments

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ACT Comments on U.S. Appeals’ Court’s Dismissal Ruling in Case Challenging Federal Funding of Embryonic Stem Cell …

Monday, August 27th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT)(ACTC), a leader in the field of regenerative medicine, today issued a statement on the U.S. Appeals Courts ruling, upholding a lower courts dismissal of the case, Sherley v. Sebelius, 11-5241, U.S. Court of Appeals for the District of Columbia Circuit (Washington), on the permissibility of federal funding of embryonic stem cell research.

This court ruling should be of considerable benefit to ACT and our embryonic stem cell-based clinical programs, commented Gary Rabin, chairman and CEO. It effectively removes major speed bumps for the National Institutes of Health (NIH) in terms of approving the several stem cell lines that we have submitted for their consideration for funding. With Fridays decisive ruling, we expect that a number of our embryonic stem cell lines will be approved for funding in coming months.

Sherley v. Sebelius had sought to block the United States Health and Human Services Department and the NIH from spending federal funds for research with hESCs, contending that doing so would violate the Dickey-Wicker Amendment, a short rider attached to legislation passed in 1996.

This ruling removes a great deal of the ambiguity that has hampered legislative attempts to provide an efficient mechanism for federal funding of hESC research, continued Mr. Rabin. The path for legislators to enact such legislation has now been cleared, and in that case we are optimistic that there could be encouraging new developments in the legislative arena, as well, in coming months. We would certainly hope that our patented, proprietary embryo-safe single-cell blastomere technique would be a part of any such conversation. We feel that if we could educate more Americans about this technique, and how directly and effectively it addresses the various ethical objections to hESC research, that broad support for the technique and the field overall would quickly fall into place.

More commentary on Fridays court ruling will be posted today on Mr. RabinsChairmans blog.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

Continued here:
ACT Comments on U.S. Appeals’ Court’s Dismissal Ruling in Case Challenging Federal Funding of Embryonic Stem Cell ...

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New partnership to drive mass production of life-saving stem cells – Commercialization Impact Prize is first of its …

Saturday, August 25th, 2012

TORONTO, ON Stem cells hold great promise for treating and curing numerous diseases; however, a major challenge facing scientists is how to produce stem cells in the massive quantities required for clinical use. The McEwen Centre for Regenerative Medicine (McEwen Centre) and the University of Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM) are partnering to establish a fund that will drive research in this area. Several University of Toronto regenerative medicine scientists are affiliated with CCRM and the Scientific Director is Dr. Peter Zandstra of the Institute of Biomaterials and Biomedical Engineering.

The McEwen Centre-CCRM Commercialization Impact Prize launches today, and will solicit innovative ideas from regenerative medicine scientists working in labs throughout the McEwen Centre. The winning team(s) will be awarded up to $600,000 to pursue research that will determine how to manufacture stem cells for clinical use and drug screening.

This private-public funding partnership is an important step forward to accelerating the advance of a discovery from a lab bench to the patient and onto the global market. Scientists at the McEwen Centre are making significant progress towards finding a cure for diseases such as Type 1 diabetes and heart disease. Collaborative partnerships are the key to discovering the cures sooner! says Rob McEwen, co-founder of the McEwen Centre, and Chief Owner, McEwen Mining.

Deadline for submissions is October 15, 2012. The Prize will fund up to two, 2-year projects that address the following challenges:

Making the transition from pre-clinical to clinical mass production; and, Scaling up stem cell manufacturing for high throughput drug screening.

Overcoming the scale-up and manufacturing challenge of stem cells would be a huge advancement for the regenerative medicine [RM] industry and this initiative fits in perfectly with our mandate to bridge the RM commercialization gap, explains Dr. Michael May, CEO of the Centre for Commercialization of Regenerative Medicine. Were very pleased to be working with the McEwen Centre, already a partner of ours, to make this happen.

The Commercialization Impact Prize budget template and application form can be found here: http://ccrm.ca/Commercialization-Impact-Prize or http://mcewencentre.com/ccrm

About McEwen Centre for Regenerative Medicine The McEwen Centre for Regenerative Medicine was founded by Rob and Cheryl McEwen in 2003 and opened its doors in 2006. The McEwen Centre for Regenerative Medicine, part of Toronto-based University Health Network, is a world leading centre for stem cell research, facilitating collaboration between renowned scientists from 5 major hospitals in Toronto, the University of Toronto and around the world. Supported by philanthropic contributions and research grants, McEwen Centre scientists strive to introduce novel regenerative therapies for debilitating and life threatening illnesses including heart disease, spinal cord injury, diabetes, diseases of the blood, liver and arthritis.

About Centre for Commercialization of Regenerative Medicine (CCRM) CCRM, a Canadian not-for-profit organization funded by the Government of Canadas Networks of Centres of Excellence program and six institutional partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM translates scientific discoveries into marketable products for patients. CCRM launched in Torontos Discovery District on June 14, 2011.

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New partnership to drive mass production of life-saving stem cells - Commercialization Impact Prize is first of its ...

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Press Release

Tuesday, August 21st, 2012

Advanced Cell Technology Inc.Posted on:20 Aug 12

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Scotlands NHS Lothian has been confirmed as a site for its Phase I/II human clinical trial for Stargardts Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

NHS Lothian should be a superb partner for our EU clinical trial for SMD, said Gary Rabin, chairman and CEO of ACT. We are particularly pleased to be working with the Principal Investigator, Professor BaljeanDhillon, and his team. Additionally, we would like to thank the men and women of the Scottish Development Authority and Scottish National Blood Transfusion Service (SNBTS) for their tireless efforts to help make this history-making clinical trial a reality.

This approved, Phase I/II clinical trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD. It is similar in design to the companys US trials for SMD and dry age-related macular degeneration initiated in July 2011.

SMD represents an important unmet need in the wider clinical arena of macular degeneration, said Professor Dhillon, BMed Sci, BM BS, FRCS, Consultant Ophthalmic Surgeon, at the Princess Alexandra Eye Pavilion, NHS Lothian andHonorary Professor of Ophthalmology at the University of Edinburgh. This trial will evaluate a promising potential new treatment for this condition, using hESC-derived RPE cells.

Professor Marc Turner, Medical Director of SNBTS continued, hESC-derived RPE cells represent one of the first of a new generation of regenerative therapies and is an example of the high quality clinical research being conducted in, and supported by, NHS Scotland which we hope will help to transform medicine over the coming decades.

On July 30, the company announced that the third patient in this SMD clinical trial had been treated.

More information on the companys clinical trials will be posted today on Mr. RabinsChairmans blog.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

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Press Release

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ACT Announces Scotland’s NHS Lothian as Additional Site for EU Clinical Trial Using hESC-Derived RPE Cells for Macular …

Monday, August 20th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Scotlands NHS Lothian has been confirmed as a site for its Phase I/II human clinical trial for Stargardts Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

NHS Lothian should be a superb partner for our EU clinical trial for SMD, said Gary Rabin, chairman and CEO of ACT. We are particularly pleased to be working with the Principal Investigator, Professor BaljeanDhillon, and his team. Additionally, we would like to thank the men and women of the Scottish Development Authority and Scottish National Blood Transfusion Service (SNBTS) for their tireless efforts to help make this history-making clinical trial a reality.

This approved, Phase I/II clinical trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD. It is similar in design to the companys US trials for SMD and dry age-related macular degeneration initiated in July 2011.

SMD represents an important unmet need in the wider clinical arena of macular degeneration, said Professor Dhillon, BMed Sci, BM BS, FRCS, Consultant Ophthalmic Surgeon, at the Princess Alexandra Eye Pavilion, NHS Lothian and Honorary Professor of Ophthalmology at the University of Edinburgh. This trial will evaluate a promising potential new treatment for this condition, using hESC-derived RPE cells.

Professor Marc Turner, Medical Director of SNBTS continued, hESC-derived RPE cells represent one of the first of a new generation of regenerative therapies and is an example of the high quality clinical research being conducted in, and supported by, NHS Scotland which we hope will help to transform medicine over the coming decades.

On July 30, the company announced that the third patient in this SMD clinical trial had been treated.

More information on the companys clinical trials will be posted today on Mr. RabinsChairmans blog.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

Excerpt from:
ACT Announces Scotland’s NHS Lothian as Additional Site for EU Clinical Trial Using hESC-Derived RPE Cells for Macular ...

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Building Body Parts: Ears, Muscles and More!

Monday, August 20th, 2012

BACKGROUND: According to the U.S. Department of Health and Human Services, regenerative medicine is the next evolution of medical treatments. Regenerative medicine offers the potential for the body to heal itself. Scientists at the Wake Forest Institute for Regenerative Medicine in Winston-Salem, N.C., were the first in the world to engineer lab-grown organs that were successfully implanted into humans. Now, the team of researchers is working to engineer more than 30 different replacement tissues and organs to develop cell therapies with the goal of curing a variety of diseases. (SOURCE: Wake Forest Institute for Regenerative Medicine)

LAB-GROWN URETHRAS: Researchers from Wake Forest were the first in the world to use patients own cells to build tailor-made urine tubes in the lab and successfully replace damaged tissue in five boys in Mexico. The boys were unable to urinate due to a pelvic injury. After receiving the lab-grown urethras, all the boys continue to do well with normal or near-normal urinary flow. The urethras were grown on biodegradable mesh scaffolds made of a polyester compound. The scaffolds were seeded with cells taken from the patients own bladders and incubated in the lab for four to seven weeks. They were then used to repair damaged segments of the boys urethras. For us, really, our goal here at the Institute is really to try to complete technologies that we can get to patients to make their lives better, so anytime that were able to do that, improve the quality of patients lives, we feel like thats part of our mission, Anthony Atala, M.D., Director, Wake Forest Institute for Regenerative Medicine, told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Atala and WebMD article)

GROWING EARS: Scientists are working on printing ears in the lab. What we can do is we can take any three dimensional image of an ear, and it can be put into the computer, and that will generate an image within the printer that then prints that specific three dimensional structure, John Jackson, Ph.D., Associate Professor, Wake Forest Institute for Regenerative Medicine, told Ivanhoe. Right now, implants that are commercially-available are hard and rigid. They also cause problems with erosion through the skin. The new, tailor-made ears are flexible and patient-specific. In animal studies, the lab-grown ears have been shown to cause less erosion. The next step is to print the ears for use in humans. To be able to take a structure, generate a 3D implant and have that as a potential treatment for a patient who has lost an ear, thats very exciting, Dr. Jackson told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Jackson)

ENGINEERING MUSCLE: Researchers are also looking to see if they can engineer tissue that resembles muscle to repair small injuries in the body. They take biopsies from skeletal muscles and culture out the stem cells from the muscle. They then seed the cells onto a scaffold and condition the scaffold and a bioreactor to exercise muscle in-vitro. Then, they use that construct as an implant to accelerate regeneration and repair of injured muscle in the body. Scientists have been studying the engineered muscle in animals, and the next step is to try it in humans. For me, personally, its fantastic because you dont often get an opportunity to do research thats not only compelling but that can result in therapies that can help people on a daily basis and really improve their quality of life, George Christ, Ph.D., Professor of Regenerative Medicine, Wake Forest Institute for Regenerative Medicine, told Ivanhoe.

(SOURCE: Ivanhoe interview with Dr. Christ)

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Building Body Parts: Ears, Muscles and More!

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Biostem Medical Director, Dr. Marina Pizarro Performs First Biostem Method(TM) of Hair Re-Growth Procedures at Orlando …

Monday, August 13th, 2012

CLEARWATER, FL--(Marketwire -08/13/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company) is a fully reporting public company in the stem cell regenerative medicine sciences sector. President, John Satino announced today that the Pizarro Hair Restoration Clinic in Orlando, Florida is now equipped and ready to begin offering The Biostem Method of hair re-growth using the patient's own adult cells in a minimally invasive, painless procedure. In addition, Biostem Medical Director and Trainer, Dr. Marina Pizarro is ready to offer onsite training to new Biostem affiliates.

According to Satino, "This week, Dr. Pizarro treated her first two patients using The Biostem Method of hair re-growth in her Orlando office. This paves the way for Biostem to start offering affiliate agreements throughout the country in response to the many inquiries from physicians who want to offer this transplant alternative to their patients. We are making plans to open affiliate offices in major cities soon, after which we will expand the services to rural and international locations focusing first on Europe and Asia."

As a side note, Satino stated that, "While the industry typically sees more males requesting hair transplant for hair re-growth solutions, it is interesting that the first two treatments Dr. Pizarro performed were on women. Statistics do show that women suffer hair loss in significant numbers, yet are less likely to go through the transplant procedure. The Biostem Method finally offers women as well as men, a viable and proven alternative."

About Biostem U.S. Corporation Biostem U.S., Corporation (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

See the article here:
Biostem Medical Director, Dr. Marina Pizarro Performs First Biostem Method(TM) of Hair Re-Growth Procedures at Orlando ...

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Is the cell therapy sector outperforming the major indices?

Sunday, August 12th, 2012
Tweet 

So here's what I did today.  I built a portfolio of public companies focused exclusively or predominately in the cell therapy space.  I excluded any companies that are in the sector but their products/services constitute less than a significant majority of their revenue and/or expenses.  The portfolio sits at 29 companies.  Here's the list:


Here's how the portfolio performs against the Dow Jones, Standard and Poor's, and NASDAQ indices so far this year.


When looking at the period 1 January 2012 to 10 August 2012, the cell therapy portfolio is up 42%, Dow Jones up 8%, Standard and Poor's up 12% and NASDAQ up 16%.

In the context of how much we hear about how harsh this sector is or has been on investors, I found today's analysis interesting and, honestly, pleasantly surprising.

This snapshot is useful but has its limitations. I'm relying on Google Finance for accuracy of the information provided.  Do your own due diligence. Invest accordingly.  I hope this helps.

--Lee

This snapshot has been brought to you by Cell Therapy Group: all cell therapy, all the time! 🙂

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Is the cell therapy sector outperforming the major indices?

Sunday, August 12th, 2012
Tweet 

So here's what I did today.  I built a portfolio of public companies focused exclusively or predominately in the cell therapy space.  I excluded any companies that are in the sector but their products/services constitute less than a significant majority of their revenue and/or expenses.  The portfolio sits at 29 companies.  Here's the list:


Here's how the portfolio performs against the Dow Jones, Standard and Poor's, and NASDAQ indices so far this year.


When looking at the period 1 January 2012 to 10 August 2012, the cell therapy portfolio is up 42%, Dow Jones up 8%, Standard and Poor's up 12% and NASDAQ up 16%.

In the context of how much we hear about how harsh this sector is or has been on investors, I found today's analysis interesting and, honestly, pleasantly surprising.

This snapshot is useful but has its limitations. I'm relying on Google Finance for accuracy of the information provided.  Do your own due diligence. Invest accordingly.  I hope this helps.

--Lee

This snapshot has been brought to you by Cell Therapy Group: all cell therapy, all the time! 🙂

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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