StemCell Therapy

Robert A. Freitas Jr., Nanomedicine, Volume I: Basic Capabilities, Landes Bioscience, Georgetown, TX, 1999; http://www.nanomedicine.com/NMI.htm

Nanomedicine, Vol. I: Basic Capabilities (Landes Bioscience, 1999). The first volume of the Nanomedicine book series describes the set of basic capabilities of molecular machine systems that may be required by many, if not most, medical nanorobotic devices, including the physical, chemical, thermodynamic, mechanical, and biological limits of such devices. Specific topics include the abilities to recognize, sort and transport important molecules; sense the environment; alter shape or surface texture; generate onboard energy to power effective robotic functions; communicate with doctors, patients, and other nanorobots; navigate throughout the human body; manipulate microscopic objects and move about inside a human body; and timekeep, perform computations, disable living cells and viruses, and operate at various pressures and temperatures.

Japanese language version of Nanomedicine, Vol. I, published in 2007 by Yakuji Nippo, Ltd:

1999 Robert A. Freitas Jr. All Rights Reserved.

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NMI Table of Contents Page - Nanomedicine

New York College of Health Professions has been a pioneer in Holistic Health and Wellness for 30 years. It is the only private non-profit institutionally accredited college of its kind in the New York metropolitan area. The College mission is to provide education and community service in these areas.

The campus is conveniently located in Syosset, Long Island, with 3 additional locations in New York City in Manhattan on the upper west side at the world famous Riverside Church (120th Street near Columbia University and Barnard College), downtown on Houston Street in the University Settlement in the Soho/Chinatown neighborhood and in a new midtown site at the NY Open Center on East 30th Street. New York College also owns a facility in China where students and friends can visit.

The College has one of the finest and largest Holistic Health Clinics which provides affordable treatments to the public in Massage Therapy, Acupuncture, Reflexology and Herbal Medicine.

New York College is the only private non-profit institutionally accredited college of its kind in the tri-state area. It has institutional accreditation by the New York State Board of Regents and the Commissioner of Education*, a nationally recognized accrediting agency, and accreditation from the Accreditation Commission for Acupuncture and Oriental Medicine** (ACAOM) for its Masters programs. *located at 89 Washington Avenue, Albany, NY 12234 (518) 474-3852. **ACAOM: 14502 Greenview Dr., ste 300B, Laurel, MD 20708 (301) 313-0855

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LASIK is a surgical procedure for correcting near sightedness(myopia), far sightedness(hyperopia) and cylindrical(astigmatic) refractive errors. LASIK stands for Laser-Assisted in Situ Keratomileusis.

Have you been thinking of laser vision correction? Shed your doubts, concerns, specs and contact lenses, because blade free LASIK has arrived. With this technology, laser vision correction procedure has become 100 percent blade-free and completely safe.

In any LASIK procedure the first step is to create a corneal flap. In standard LASIK the surgeon uses a hand-held oscillating blade called microkeratome to cut the corneal flap. The flap is then folded and the Excimer laser treats the cornea to correct the refractive error.

In blade free LASIK, femtosecond laser has replaced the steel blade for creation of the corneal flap which improves visual outcome and post-operative comfort for the patient.

When you opt for advanced blade free LASIK procedure you get a completely integrated, personalized vision correction procedure based on cutting edge technology at every step. NASA recommends blade free LASIK to aspiring astronauts to get rid of their specs, as it can withstand high gravitational forces and has been found to be stable and secure even in extreme environmental conditions.

Advantages

For people with nearsightedness (myopia), farsightedness (hyperopia) or astigmatism, LASIK surgery could be the key to a life free of bulky spectacles or contact lenses. But not everybody is a suitable candidate for this type of laser eye surgery. Here are the few main questions a LASIK surgeon is likely to ask you during a consultation.

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Lasik eye surgery - Centre For Sight

J Nat Sci Biol Med. 2015 Jan-Jun; 6(1): 2934.

Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, Sehora, Jammu and Kashmir, India

1Department of Physiology, Government Medical College, Patiala, Punjab, India

This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Teeth are the most natural, noninvasive source of stem cells. Dental stem cells, which are easy, convenient, and affordable to collect, hold promise for a range of very potential therapeutic applications. We have reviewed the ever-growing literature on dental stem cells archived in Medline using the following key words: Regenerative dentistry, dental stem cells, dental stem cells banking, and stem cells from human exfoliated deciduous teeth. Relevant articles covering topics related to dental stem cells were shortlisted and the facts are compiled. The objective of this review article is to discuss the history of stem cells, different stem cells relevant for dentistry, their isolation approaches, collection, and preservation of dental stem cells along with the current status of dental and medical applications.

Keywords: Cell culture techniques, stem cells, stem cell research, tissue banks, tissue engineering

Regenerative capacity of the dental pulp is well-known and has been recently attributed to function of dental stem cells. Dental stem cells offer a very promising therapeutic approach to restore structural defects and this concept is extensively explored by several researchers, which is evident by the rapidly growing literature in this field. For this review article a literature research covering topics related to dental stem cells was made and the facts are compiled.

A web-based research on Medline (www.pubmed.gov) was done. To limit our research to relevant articles, the search was filtered using terms review, published in the last 10 years and dental journals. Various keywords used for research were regenerative dentistry (128 articles found), dental stem cells (111 articles found), dental stem cells banking (2 articles found), stem cells from human exfoliated deciduous teeth (SHED) (11 articles found). For each heading in the review, relevant articles were chosen and arranged in chronological order of publication date so as to follow the development of the research topic. This review screened about 250 articles to get the required knowledge update. Relevant data were then compiled with aim of providing basic information as well as latest updates on dental stem cells.

Stem cells also known as progenitor or precursor cells are defined as clonogenic cells capable of both self-renewal and multi-lineage differentiation.[1] In 1868, the term stem cell for the first time appeared in the works of German biologist Haeckel.[2] Wilson coined the term stem cell.[3] In 1908, Russian histologist, Alexander Maksimov, postulated existence of hematopoietic stem cells at congress of hematologic society in Berlin.[4] There term stem cell was proposed for scientific use.

Stem cells have manifold applications and have contributed to the establishment of regenerative medicine. Regenerative medicine is the process of replacing or regenerating human cells, tissues or organs for therapeutic applications.[5] The concept of regeneration in the medical field although not new has significantly advanced post the discovery of stem cells and in recent times have found its application in dentistry following identification of dental stem cells. Although, the concept of tooth regeneration was initially not accepted the ground-breaking work by stomatologist G. L. Feldman (1932) showed evidence of regeneration of dental pulp under certain optimal biological conditions. This work introduced the biological-aseptic principle of tooth therapy to achieve pulp regeneration using dentine fillings as building material for stimulating pulp regeneration.[6] Nevertheless subsequent researchers further improved this work.[6] Major breakthrough in dental history was achieved in year 2000 when Gronthos et al. identified and isolated odontogenic progenitor population in adult dental pulp.[7] These cells were referred to as dental pulp stem cells (DPSCs). Since this discovery several researchers have reported varieties of dental stem cells, which are described below:

Human dental stem cells that have been isolated and characterized are:

Stem cells from various sources and their features studied by various researchers are presented in .[7,8,11,12,13,14,15,16,17,18]

Stem cells and their features studied by various researchers (at full page width)

DPSCs are mesenchymal type of stem cells inside dental pulp.[19] DPSCs have osteogenic and chondrogenic potential in vitro and can differentiate into dentin, in vivo and also differentiate into dentin-pulp-like complex.[7] Recently, immature dental pulp stem cells[20] were identified which are a pluripotent sub-population of DPSC generated using dental pulp organ culture.

DPSCs are putative candidate for dental tissue engineering due to:[21]

Easy surgical access to the collection site and very low morbidity after extraction of the dental pulp.

DPSCs can generate much more typical dentin tissues within a short period than nondental stem cells.

Can be safely cryopreserved and recombined with many scaffolds.

Possess immuno-privilege and anti-inflammatory abilities favorable for the allotransplantation experiments.

Four commonly used stem cell identification techniques[22] are:

Fluorescent antibody cell sorting: Stem cells can be identified and isolated from mixed cell populations by staining the cells with specific antibody markers and using a flow cytometer.

Immunomagnetic bead selection.

Immunohistochemical staining.

Physiological and histological criteria, including phenotype, proliferation, chemotaxis, mineralizing activity and differentiation.

Various conventional methods to isolate stem cells from dental pulp are listed below:

Enzymatic digestion of whole dental pulp tissue in solution of 3% collagenase Type I for 1 h at 37C is done. Through process of filtering and seeding, cells with diameter between 3 and 20 m are obtained for further culture and amplification. Based on this approach, small-sized cell populations containing a high percent of stem cells can be isolated.

Enzymatic digestion of the dental pulp tissue is done to prepare single cell suspension cells of which are used for colony formation containing 50 or more cells that is further amplified for experiments.

Is an immune-magnetic method used for separation of stem cell populations based on their surface antigens (CD271, STRO-1, CD34, CD45, and c-Kit). MACS is technically simple, inexpensive and capable of handling large numbers of cells but the degree of stem cell purity is low.

Is convenient and efficient method that can effectively isolate stem cells from cell suspension based on cell size and fluorescence. Demerits of this technique are a requirement of expensive equipment, highly-skilled personnel, decreased viability of FACS-sorted cells and this method is not appropriate for processing bulk quantities of cells.

Dr. Songtao Shi discovered SHED in 2003. Miura et al.[8] confirmed that SHED were able to differentiate into a variety of cell types to a greater extent than DPSCs, including osteoblast-like, odontoblast-like cells, adipocytes, and neural cells. Abbas et al.[23] investigated the possible neural crest origin of SHED. The main task of these cells seems to be the formation of mineralized tissue, which can be used to enhance orofacial bone regeneration.

Types of stem cells present in human exfoliated deciduous teeth are

Advantages of banking SHED cells[25] include: It's a simple painless technique to isolate them and being an autologous transplant they dont possess any risk of immune reaction or tissue rejection and hence immunosuppressive therapy is not required. SHED may also be useful for close relatives of the donor such as grandparents, parents and siblings. Apart from these, SHED banking is more economical when compared to cord blood and may be complementary to cord cell banking. The most important of all these cells are not subjected to same ethical concerns as embryonic stem cells.

Step 1: Tooth collection

Freshly-extracted tooth is transferred into vial containing hypotonic phosphate buffered saline solution (up to four teeth in one vial). Vial is then carefully sealed and placed into thermette, after which the carrier is placed into an insulated metal transport vessel. Thermette along with insulated transport vessel maintains the sample in a hypothermic state during transportation. This procedure is described as sustentation. The time from harvesting to arrival at processing storage facility should not exceed 40 h.

Step 2: Stem cell isolation

Tooth surface is cleaned by washing three times with Dulbecco's phosphate buffered saline without Ca2+ and Mg2+. Disinfection is done and again washed with PBSA. Pulp tissue is isolated from the pulp chamber and is placed in a sterile petri dish, washed at least three times with PBSA. The tissue digestion is done with collagenase Type I and dispase for 1 h at 37C. Isolated cells are passed through a 70 um filter to obtain single cell suspensions. Then the cells are cultured in a MSC medium. Usually isolated colonies are visible after 24 h.

Step 3: Stem cell storage.

The approaches used for stem cell storage are: (a) Cryopreservation (b) magnetic freezing.

It is the process of preserving cells or whole tissues by cooling them to sub-zero temperatures. Cells harvested near end of log phase growth (approximately. 8090% confluent) are best for cryopreservation. Liquid nitrogen vapour is used to preserve cells at a temperature of <150C. In a vial 1.5 ml of freezing medium is optimum for 12 106 cells.

This technology is referred to as cells alive system (CAS), which works on principle of applying a weak magnetic field to water or cell tissue which will lower the freezing point of that body by up to 67C. Using CAS, Hiroshima University (first proposed this technology) claims that it can increase the cell survival rate in teeth to 83%. CAS system is a lot cheaper than cryogenics and more reliable.

Primary incisors and canines with no pathology and at least one third of root left can be used for SHED banking. Primary molar roots are not recommended for sampling as they take longer time to resorb, which may result in an obliterated pulp chamber that contains no pulp, and thus, no stem cells.[26] However in some cases where deciduous molars are removed early for orthodontic reasons, it may present an opportunity to use these teeth for stem cell banking.

MSCs residing in the apical papilla of permanent teeth with immature roots are known as SCAP. These were discovered by Sonoyama et al.[9] SCAP are capable of forming odontoblast-like cells, producing dentin in vivo, and are likely cell source of primary odontoblasts for the formation of root dentin. SCAP supports apexogenesis, which can occur in infected immature permanent teeth with periradicular periodontitis or abscess. SCAP residing in the apical papilla survive such pulp necrosis because of their proximity to the periapical tissue vasculature. Hence even after endodontic disinfection, SCAP can generate primary odontoblasts, which complete root formation under the influence of the surviving epithelial root sheath of Hertwig.[9]

Seo et al.[11] described the presence of multipotent postnatal stem cells in the human periodontal ligament (PDLSCs). When transplanted into rodents, PDLSCs had the capacity to generate a cementum/periodontal ligament-like structure and contributed to periodontal tissue repair. These cells can also be isolated from cryopreserved periodontal ligaments while retaining their stem cell characteristics, including single-colony strain generation, cementum/periodontal-ligament-like tissue regeneration, expression of MSC surface markers, multipotential differentiation and hence providing a ready source of MSCs.[27]

Using a mini pig model, autologous SCAP and PDLSCs were loaded onto hydroxyapatite/tricalcium phosphate and gelfoam scaffolds, and implanted into sockets in the lower jaw, where they formed a bioroot encircled with the periodontal ligament tissue and in a natural relationship with the surrounding bone.[28] Trubiani et al.[29] suggested that PDLSCs had regenerative potential when seeded onto three dimensional biocompatible scaffold, thus encouraging their use in graft biomaterials for bone tissue engineering in regenerative dentistry, whereas Li et al.[30] have reported cementum and periodontal ligament-like tissue formation when PDLSCs are seeded on bioengineered dentin.

Although tooth banking is currently not very popular the trend is gaining acceptance mainly in the developed countries. BioEden (Austin, Texas, USA), has international laboratories in UK (serving Europe) and Thailand (serving South East Asia) with global expansion plans. Stem cell banking companies like Store A- Tooth (Provia Laboratories, Littleton, Massachusetts, USA) and StemSave (Stemsave Inc, New York, USA) are also expanding their horizon internationally. In Japan, the first tooth bank was established in Hiroshima University and the company was named as Three Brackets (Suri Buraketto) in 2005. Nagoya University (Kyodo, Japan) also came up with a tooth bank in 2007. Taipei Medical University in collaboration with Hiroshima University opened the nation's first tooth bank in September, 2008. The Norwegian Tooth Bank (a collaborative project between the Norwegian Institute of Public Health and the University of Bergen) set up in 2008 is collecting exfoliated primary teeth from 1,00,000 children in Norway. Not last but the least, Stemade introduced the concept of dental stem cells banking in India recently by launching its operations in Mumbai and Delhi.

Most research is directed toward regeneration of damaged dentin, pulp, resorbed root, periodontal regeneration and repair perforations. Whole tooth regeneration to replace the traditional dental implants is also in pipeline. Tissue-engineering applications using dental stem cells that may promote more rapid healing of oral wounds and ulcers as well as the use of gene-transfer methods to manipulate salivary proteins and oral microbial colonization patterns are promising and possible.[31]

Adult MSCs recently identified in the gingival connective tissues (gingival mesenchymal stem cells [GMSCs]) have osteogenic potential and are capable of bone regeneration in mandibular defects. GMSCs also suppress the inflammatory response by inhibiting lymphocyte proliferation and inflammatory cytokines and by promoting the recruitment of regulatory T-cells and anti-inflammatory cytokines. Thus, GMSCs potentially promote the right environment for osseous regeneration and is currently being therapeutically explored.[32]

Researchers of the Chinese Academy of Sciences and Guangdong Provincial Key Laboratory of Stem Cell Biology and Regenerative Medicine, reported a possible method for growing teeth from stem cells obtained in urine.[33] In this study, pluripotent stem cells derived from human urine were induced to generate tooth-like structures in a group of mice with a success rates of up to 30%. The generated teeth had physical properties similar to that of normal human teeth except hardness (about one-third less in hardness of human teeth). The reported advantages to such an approach were being noninvasive technique, low cost, and use of somatic cells (instead of embryonic) that are wasted anyways. Interestingly urine-derived stem cells do not form tumors when transplanted in the body unlike other stem cells; more over autologous sourcing of these cells reduces the likelihood of rejection.

Dental stem cells have the potential to be utilized for medical applications like heart therapies,[34] regenerating brain tissue,[35] for muscular dystrophy therapies[36] and for bone regeneration.[37,38] SHED can be used to generate cartilage[39] as well as adipose tissue.[40] In 2008 first advanced animal study for bone grafting was announced resulting in reconstruction of large size cranial bone defects in rats with human DPSCs.[41]

Researchers have observed promising results in several preclinical animal studies and numerous clinical trials are now on-going globally to further validate these findings. The Obama administration has made stem cell research one of the pillars of his health program. The U.S. Army is investing over $250 million in stem cell research to treat injured soldiers in a project called Armed Forces Institute for Regenerative Medicine. It is likely that the next stem cell advance is the availability of regenerative dental kits, which will enable the dentists the ability to deliver stem cell therapies locally as part of routine dental practice. An innovative method that holds promising future is to generate induced stem cells from harvested human dental stem cells. This approach reprograms dental stem cells into an embryonic state, thus expanding their potential to differentiate into a much wider range of tissue types. Researchers have so far succeeded in making specific dental tissues or tooth like structures although in animal studies but future advances in dental stem cell research will be the regeneration of functional tooth in humans.

As human stem cell research is a relatively new area, companies developing cell therapies face several types of risks as well, and some are not able to manage them thus pushing this venture into a highly speculative enterprise. Present clinical trials are being performed on recombinant human fibroblast growth factor-2, human platelet-derived growth factor, and tricalcium phosphate (GEM-21). Looking at the ongoing clinical trials, it is too early to speculate whether all therapies based on stem cells will prove to be clinically effective.[42]

Stem cells of dental origin have multiple applications nevertheless there are certain limitations as well. The oncogenic potential of these cells is still to be determined in long-term clinical studies. Moreover, the research is mainly confined to animal models and their extensive clinical application is yet to be tested. Other major limitations are the difficulty to identify, isolate, purify and grow these cells consistently in labs. Immune rejection is also one of the issues, which require a thorough consideration; nevertheless use of autologous cells can overcome this. Lastly, stem/progenitor cells are comparatively less potent than embryonic stem cells. Teeth-like structures cannot replace actual teeth, thus a considerable research research and development efforts is required to advance the dental regenerative therapeutics. Researchers still need to grow blood and nerve supply of teeth to make them fully functional. Although not currently available, these approaches may one day be used as biological alternatives to the synthetic materials currently used. Like other powerful technologies, dental stem cell research poses challenges as well as risks. If we are to realize the benefits, meet the challenges, and avoid the risks, stem cell research must be conducted under effective, accountable systems of social-responsible oversight and control, at both the national and international levels.[43]

Source of Support: Nil.

Conflict of Interest: None declared.

3. Wilson EB. 1st ed. New York: Macmillan Company; 1996. The Cell in Development and Inheritance.

4. Maximow A. The lymphocyte as a stem cell, common to different blood elements in embryonic development and during the post-fetal life of mammals. Folia Haematol. 1909;8:12334.

6. Polezhaev LV. 1st ed. Jerusalem: Keterpress; 1972. Restoration of lost regenerative capacity of dental tissues. In: Loss and Restoration of Regenerative Capacity in Tissues and Organs of Animals; pp. 14152.

23. Abbas, Diakonov I, Sharpe P. Neural crest origin of dental stem cells. Pan European Federation of the International Association for Dental Research (PEF IADR) Seq #96-Oral. Stem Cells. 2008 Abs, 0917.

26. Reznick JB. Continuing education: Stem cells: Emerging medical and dental therapies for the dental professional. Dentaltown Mag. 2008;Oct:4253.

31. Jain A, Bansal R. Regenerative medicine: Biological solutions to biological problems. Indian J Med Spec. 2013;4:416.

Articles from Journal of Natural Science, Biology, and Medicine are provided here courtesy of Medknow Publications

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Multipotent Cell-Secreted Extracellular Matrix Supports Cartilage Formation Histogen to present at International Cartilage Repair Society 2015

CHICAGO, May 8, 2015 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, will present new research on its human extracellular matrix (hECM) material in the promotion of cartilage regeneration during the International Cartilage Repair Society (ICRS) 2015 Meeting, taking place May 8-11, 2015 in Chicago, IL. The orthobiologic applications of all of Histogen's products are being developed by its worldwide joint venture, PUR Biologics LLC.

Histogen has previously shown that hypoxia-induced multipotent cells produce soluble and insoluble materials that contain components associated with stem cell niches in the body and with scarless healing. These proteins include a variety of laminins, osteonectin, decorin, hyaluronic acid, collagen type IV, SPARC, CXCL12, NID1, NID2, NOTCH2, tenascin, thrombospondin, fibronectin, versican, and fibrillin-2. In vitro studies further demonstrated that the CCM and ECM promote the adhesion, proliferation and migration of bone marrow-derived human mesenchymal stem cells (MSCs).

In this latest research, in vivo studies with the hECM were undertaken to determine their potential as orthobiologics. Rabbit studies demonstrated the potential of the hECM to promote regeneration and repair of full-thickness articular cartilage defects. Eight weeks following hECM treatment of femoral osteochondral defects, mature bone and hyaline cartilage formation was seen, exemplified by the presence of a tide mark and integration into the adjacent cartilage. This work is currently being repeated in a goat cartilage defect model, with similar results to date.

"The efficacy we have seen with the multipotent cell-secreted ECM in bone and cartilage regeneration is unprecedented," said Ryan Fernan, CEO of PUR Biologics. "The preclinical work overwhelmingly supports use of the material as an orthobiologic to reduce inflammation and promote cartilage regeneration in the articulating joint and intervertebral spinal disc. We look forward to entering human trials for these indications, as well as to continuing our research on utilizing the product for soft tissue repair in a variety of sports injuries."

Histogen's cell conditioned media (CCM) and hECM were also evaluated in an ex vivo rabbit intervertebral spinal disc model to study the effects of these materials in an environment where an extensive inflammatory response was induced by thrombin injection. Compared to untreated controls, both the CCM and ECM treatment significantly down regulated the expression of the inflammatory cytokine genes IL-1, IL-6, TNF-alpha, as well as the genes encoding the extracellular matrix degrading enzymes MMP3, and ADAMTS4, while upregulating aggrecan expression in the annulus fibrosus and nucleus pulposus tissue.

Dr. Gail Naughton, CEO of Histogen, will present "Human Cell Conditioned Media and Extracellular Matrix Reduce Inflammation and Support Hyaline Cartilage Formation" at the ICRS 2015 meeting in Chicago on May 9, 2015. Following the event, the presentation will be available upon request.

About PUR Biologics PUR Biologics is dedicated to providing regenerative biologic solutions to address musculoskeletal surgical needs, including spine, dental, ligament and medical device coating applications. In addition to distribution of approved allograft and biologic products, PUR is focused on development of next-generation orthopedic products based upon human protein and growth factor materials for bone and tissue regeneration. For more information visit http://www.purbiologics.com.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit http://www.histogen.com.

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Novel Immunomodulatory Treatment Induces Apoptosis in Melanoma Histogen to present data at 2015 Society of Investigative Dermatology Annual Meeting

ATLANTA, May 6, 2015 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, will present new research on its 105F immunomodulatory treatment candidate for melanoma during the 2015 Society of Investigative Dermatology (SID) Annual Meeting, taking place May 6-9, 2015 in Atlanta, GA.

Histogen has previously shown that hypoxia-induced multipotent cells produce a soluble material with anti-oncologic properties, with potential benefit in the treatment of a wide range of cancers. Studies to characterize the active components of the material have identified a low molecular weight fraction (105F) which directly induces apoptosis, or controlled cell death, in 21 human cancer cell lines. In its latest research, Histogen sought to further examine the mechanism of action of 105F in melanoma through in vitro and in vivo studies.

After treatment with 105F, melanoma cells were shown to release Interleukin 6 (IL-6) and TNF a, pro-inflammatory cytokines acting as signals to the immune system. This induction of an immune "flare" in combination with tumor cell apoptosis could be critically important in recruiting immune cells to the tumor for cytotoxic attack.

"We were excited to see the dual activity of 105F, both directly inducing cancer cell death and activating an anti-tumorigenic immune response to reduce metastatic disease," said Dr. Gail Naughton, CEO and Chairman of the Board of Histogen. "These results represent a potential treatment for melanoma and other solid tumors that works through multiple channels to eliminate cancer cells, but is not toxic to the body's healthy cells."

An in vivo model of lung metastasis in C57Bl/6 mice further showed the efficacy of 105F in the treatment of melanoma. Daily intravenous injections of 105F over 14 days resulted in a significant (p=0.0049) reduction in lesions and marked immune cell infiltration as compared to controls.

Dr. Naughton will present "105F is a novel immunoadaptive treatment candidate for melanoma that induces apoptosis and the secretion of pro-inflammatory IL-6" at the 2015 SID Annual Meeting in Atlanta beginning May 6, 2015. Following the event, the presentation will be available upon request.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit http://www.histogen.com.

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Histogen's Composition for Oncology Treatments Receives US Patent

SAN DIEGO, October 8, 2014 - Histogen Oncology, a company developing innovative cancer therapies based on Histogen's regenerative medicine technology, today announced that the United States Patent & Trademark Office has issued patent 12/363,479 entitled "Extracellular matrix compositions for the treatment of cancer" to Histogen.

The patent, which is the fifth U.S. patent issued to Histogen, covers the soluble and insoluble compositions of proteins and cofactors that are secreted by multipotent stem cells through Histogen's technology process for use in the treatment of cancer. The patent claims support of the use of the compositions alone or as a delivery system for traditional chemotherapeutic agents.

Through the recent formation and funding of the Histogen Oncology joint venture, research and development of the unique, naturally secreted compositions is progressing toward a Phase I clinical trial for end stage pancreatic cancer.

"We are pleased about the timely issuance of our U.S. patent for the treatment of cancer," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "Our collaborations with top institutions continue to produce mounting evidence supporting the unique mechanism of action of our secreted material in preventing metastasis and reducing tumor load while having no toxic affect on normal cells."

Histogen's composition has shown effectiveness in inhibiting over 21 human cancer cell lines both in vitro as well as in animal models. The mechanism of action of the secreted material is through the induction of apoptosis (controlled cell death) primarily in malignant cells, so there is little to no toxicity to normal cells. Histogen Oncology is studying the efficacy of a small molecular weight fraction of the cell secreted composition as a stand alone treatment as well as in combination therapy to evaluate whether effectiveness can be demonstrated with less toxic drug doses.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit http://www.histogen.com.

Contacts Eileen Brandt, (858) 200-9520 ebrandt@histogeninc.com

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Histogen Oncology Created to Develop Novel Biologic Cancer Treatments Histogen, Inc. and Wylde, LLC Form Joint Venture

SAN DIEGO, July 8, 2014 - Histogen Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, has partnered with Southern California medical device group Wylde, LLC to create Histogen Oncology. This joint venture will focus on the development of unique cell-derived materials for cancer applications.

Under this joint venture, Histogen Oncology has acquired exclusive rights to Histogen's human multipotent cell conditioned media (CCM) and extracellular matrix (ECM) materials, as well as their derivatives, for oncology applications throughout North America. Histogen Oncology's initial clinical focus is pancreatic cancer, a highly treatment-resistant cancer in which a sub-fraction of the CCM has shown substantial preclinical promise.

"We have been very impressed with the results of Histogen's preliminary oncology work, not only because of the significant survival benefit but also because it is a naturally-derived material that is showing no toxicity," said Christopher Wiggins of Wylde, LLC. "There are so many patients out there who are not candidates for existing therapies due to the toxic nature of available drugs. This is particularly true in pancreatic cancer, where 80% of people diagnosed already have stage four disease."

In post-resection nude mouse models, intravenous treatment with the CCM sub-fraction resulted in prolonged survival by more than three fold in a majority of treated animals. In non-resection models, more than 50% of treated mice lived twice as long as the control. These results point to a potentially significant outcome for pancreatic cancer patients, and Histogen Oncology intends to progress the material toward a Phase I clinical trial for no-option pancreatic cancer patients in the coming 18 months.

Research on the mechanism responsible for cancer cell inhibition by the CCM shows the upregulation of Caspase 9 and cleaved Caspase 3, which causes cancer cells to enter apoptosis, or programmed cell death.

"The activity of the CCM sub-fraction is unique in a number of ways. Whereas most cancer therapies target rapidly dividing cells but not cancer stem cells, the inhibitory effect of this material is seen in malignant cells and circulating tumor cells as well," said Dr. Gail Naughton, CEO and Chairman of the Board of Histogen, Inc. "In addition, the activity is selective for malignant cells, supporting the proliferation of human dermal fibroblasts, embryonic stem cells and mesenchymal stem cells, while inhibiting tumor growth."

Histogen Oncology will be supported by Histogen's research group and funded by Wylde, LLC., made up of experts from the surgery and medical device industries. The creation of this joint venture allows for dedicated development of the CCM sub-fraction as a cancer treatment, as Histogen continues to allocate resources to the Company's revenue-generating aesthetic and promising therapeutic programs.

"We are extremely excited to fuel and push the next stage of development for this innovative and potentially life-saving therapy," said Wiggins. "The next generation of cancer treatment will have cell-signaling at its core, be beneficial in combination with existing therapies as well as stand alone, and provide an option to patients who currently have none. We believe Histogen's material has all of those characteristics and more."

About Histogen Aesthetics Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit http://www.histogen.com.

Contacts Eileen Brandt, (858) 200-9520 ebrandt@histogeninc.com

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Histogen Aesthetics Acquires CellCeuticals Biomedical Skin Treatments

SAN DIEGO, March 10, 2014 - Histogen Aesthetics, a subsidiary of regenerative medicine company Histogen, Inc. focused on skin care and cosmeceuticals, announced today that the Company has acquired the CellCeuticals Biomedical Skin Treatments line of skincare products.

Histogen Aesthetics will continue sales of the eleven existing CellCeuticals Biomedical Skin Treatments skincare products, while bringing new innovation to the line through the addition of a unique regenerative medicine technology, working to improve skin aging at a cellular level.

"We have long admired the science, clinical data and elegant formulas behind the CellCeuticals line, and see it as an ideal fit for our recently revitalized aesthetics subsidiary," said Dr. Gail K. Naughton, CEO and Chairman of Histogen, Inc. "We are very excited to begin infusing unique cell-signaling factors into the CellCeuticals regimen, to truly transform skin one cell at a time."

Dr. Naughton has spent more than 30 years in tissue engineering and regenerative medicine, and holds over 100 patents in the field. She founded Histogen in 2007, focused on developing therapies that work to stimulate the stem cells in the body to regenerate tissues and organs. Through this work, she has also seen how different compositions of human proteins can have cosmetic benefits, particularly in anti-aging and rejuvenation.

"I am pleased that the CellCeuticals Biomedical Skin Treatments will evolve, and see Histogen Aesthetics as an excellent home for this innovative product line," said Paul Scott Premo, co-founder of CellCeuticals Skin Care, Inc. "I believe the addition of this regenerative medicine technology will be the opportunity to introduce a new generation of products that are the vanguard of regenerative skin care."

The CellCeuticals system is made up of eleven distinctive products including the Extremely Gentle Skin Cleanser, CellGenesis Regenerative Skin Treatment, and PhotoDefense Color Radiance SPF55+ with proprietary and patented PhotoPlex technology. The line is currently available at retailers including QVC.com, Dermstore.com, and Nordstrom.com, as well as http://www.cellceuticalskincare.com.

About Histogen Aesthetics Histogen Aesthetics LLC, formed in 2008 as a subsidiary of Histogen, Inc., focuses on the development of innovative skin care products utilizing regenerative medicine technology. Histogen Aesthetics' technology is based on the expertise of founder Dr. Gail K. Naughton, in which fibroblasts are grown under unique conditions, producing a complex of naturally-secreted proteins and synergistic bio-products known to stimulate skin cells to regenerate and rejuvenate tissues. In 2014, Histogen Aesthetics acquired CellCeuticals Biomedical Skin Treatments, a line of scientifically-proven products that reactivate cells to help aging skin perform and look healthier and younger. For more information, visit http://www.cellceuticalskincare.com.

About Suneva Medical, Inc. Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process is also being researched for oncology applications, and in orthopedics through joint venture PUR Biologics, LLC. For more information, please visit http://www.histogen.com.

Contacts Eileen Brandt, (858) 200-9520 ebrandt@histogeninc.com

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Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally

SAN DIEGO, CA, January 14, 2014 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, today announced that they have entered into an international license agreement with Suneva Medical, Inc. for physician-dispensed aesthetic products containing Histogen's proprietary multipotent cell conditioned media (CCM).

This agreement is an amendment to the existing license between Histogen and Suneva Medical, through which Suneva has exclusively licensed the Regenica skincare line within the United States since February 2012. Under the terms of the international agreement, Suneva Medical is now the exclusive licensee for the distribution of Regenica through the physician-dispensed channel in Europe, most of Asia, South America, Canada, Australia, and the Middle East.

"Not only has Suneva had sales success, but they have generated enthusiasm around the Regenica product line and our technology here in the US," said Gail K. Naughton, Ph.D., CEO and Chairman of the Board of Histogen. "We are excited about expanding our skincare partnership internationally, and look forward to an exciting year for Regenica."

Regenica contains Histogen's proprietary Multipotent Cell Conditioned Media, made up of soluble cell-signaing proteins and growth factors which support the body's epidermal stem cells and renew skin throughout life. Through Histogen's technology process, which mimics the embryonic environment including conditions of low oxygen and suspension, cells are triggered to become multipotent, and naturally produce these proteins associated with skin renewal and scarless healing.

"We believe that Regenica truly is the next generation in growth factor technology, and we are extremely pleased that the products will now have a presence around the world," said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Suneva Medical. "Our relationship with Histogen in the US physician market has been a valuable asset to Suneva, and has laid the groundwork for international success."

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit http://www.histogen.com.

About Suneva Medical, Inc. Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the general dermatology and aesthetic markets. The company currently markets Artefill in the US, Korea, Singapore and Vietnam; Refissa and Regenica Skincare in the U.S.; and Bellafill in Canada. For more information, visit http://www.sunevamedical.com.

Regenica is a trademark of Suneva Medical, Inc. The Multipotent Cell Conditioned Media Complex is covered by U.S. patents #8,257,947 and #8,524,494.

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Multipotent Stem Cell Proteins Support Soft Tissue Regeneration Histogen to present data at TERMIS AM Annual Conference in Atlanta

ATLANTA, November 13, 2013 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, announced that Dr. Michael Zimber will give a podium presentation entitled "Human Multipotent Stem Cell Proteins Support Soft Tissue Regeneration" today at the Tissue Engineering and Regenerative Medicine International Society (TERMIS) Americas Annual Meeting in Atlanta, GA.

Through its proprietary technology process that simulates the conditions of the embryonic environment, Histogen has developed a human extracellular matrix (hECM) material composed of stem cell-associated proteins including SPARC, decorin, collagens I,III,IV, V, fibronectin, fibrillin, laminins, and hyaluronic acid. The hECM's distinctive composition of growth factors and other proteins are known to stimulate stem cells in the body, regenerate tissues, and promote scarless healing.

Histogen sought to examine whether the hECM may promote scarless healing in full thickness wounds, similar to that seen in fetal healing, using a variety of forms of the material, including hollow spheres to maximize void fill volume. In preclinical studies, all hECM-treated wounds healed rapidly with minimum contractions, and the hECM microspheres had a statistically significant improvement in healing as compared to the controls (p<0.05) and produced a 25% thicker dermis. In addition, hECM applied topically after microneedling resulted in up to a 3X dermal thickening.

"We are very pleased that our propriety materials produced by hypoxia-induced human multipotent stem cells have shown significant healing results in both soft and hard tissues," said Dr. Gail Naughton, CEO and Chairman of the Board of Histogen. "These results open new therapeutic markets, show tremendous potential for our material in cutaneous wound care and orthopedics, as well as support the expansion of our aesthetic pipeline to include soft tissue fillers."

In addition to "Human Multipotent Stem Cell Proteins Support Soft Tissue Regeneration", Dr. Zimber will also be presenting "Human Multipotent Stem Cell Proteins Support Osteogenesis In Vitro" during the TERMIS AM Annual Meeting taking place November 10-13, 2013 in Atlanta. Following the event, these presentations will be available upon request.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit http://www.histogen.com.

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Multipotent Stem Cell Proteins Support Rejuvenation while Inhibiting Skin Cancer Histogen to present data at TERMIS AP Annual Conference in Shanghai

San Diego, October 24, 2013 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, announced that the Company's Chairman and CEO, Dr. Gail Naughton, will present today at the Tissue Engineering and Regenerative Medicine International Society (TERMIS) Asia Pacific Annual Meeting in Shanghai, China.

Through its proprietary technology process that simulates the conditions of the embryonic environment, Histogen is uniquely able to trigger the de-differentiation of skin cells into multipotent stem cells without genetic manipulation. The cells express key stem cell markers including Oct4, Sox2 and Nanog, and secrete a distinctive composition of growth factors and other proteins known to stimulate stem cells in the body, regenerate tissues, and promote scarless healing.

It is the soluble and insoluble compositions of multipotent proteins and growth factors resulting from this process that have been shown to both promote skin regeneration and induce controlled cell death in multiple skin cancers.

"The anti-aging and rejuvenation benefits of human multipotent stem cell proteins have been shown in several clinical studies, and have resulted in the material's use as a thriving next-generation ingredient for skin care," said Dr. Naughton. "In parallel, we have also been studying the anti-cancer activity of these proteins, and have shown that, just as in the embryonic environment, they support normal tissue growth while resulting in the controlled death of cancer cells".

In vitro studies performed with Histogen's material have shown reduction in Squamous Cell Carcinoma (SCC), Basal Cell Carcinoma, and Melanoma cell number through the mechanism of apoptosis, or controlled cell death, induced by the upregulation of Caspase in these cancer cells. In one in vivo model, melanoma load was reduced by up to 80% versus the control (p<0.05) by the addition of the insoluble multipotent stem cell proteins, and a dose response curve was seen. Similar inhibition was seen with SCC. In subcutaneous mouse experiments, tumor growth was inhibited by 70-90%.

"Human Multipotent Stem Cell Proteins Stimulate Skin Regeneration While Inducing Skin Cancer Cell Apotosis" will be presented by Dr. Naughton during the TERMIS AP Annual Meeting taking place October 23-26, 2013 in Shanghai. Further information and data on the ability of multipotent stem cell proteins to induce apoptosis in skin cancers can be found in the publication Journal of Cancer Therapy at file.scirp.org/Html/1-8901700_33923.htm.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit http://www.histogen.com.

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Histogen to present at 2013 STEM CELL MEETING ON THE MESA

San Diego, October 11, 2013 - Histogen, Inc., a regenerative medicine company developing therapies for conditions including hair loss and cancer, announced today that Histogen CEO Gail K. Naughton, Ph.D. will give a company presentation at the 3rd Annual Regen Med Partnering Forum, part of the Stem Cell Meeting on the Mesa to be held October 14-16 in La Jolla, CA.

Histogen's solutions are based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. The technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of proteins that have been shown to support stem cell growth and differentiation.

"It is an exciting time for Histogen, as we continue to move the technology forward with expanded partnerships in skincare, compelling clinical data in both male and female hair loss, and early but exciting results in orthopedics," said Dr. Naughton. "We look forward to sharing our story during the Stem Cell Meeting on the Mesa, and to progressing our products even further through growing relationships with industry leaders and through our potential merger with Stratus Media to form publicly-traded Restorgenex."

Organized by the Alliance for Regenerative Medicine (ARM), the California Institute for Regenerative Medicine (CIRM) and the Sanford Consortium for Regenerative Medicine, the 2013 Stem Cell Meeting on the Mesa is a three-day conference aimed at bringing together senior members of the regenerative medicine industry with the scientific research community to advance stem cell science into cures. The Regen Med Partnering Forum, held October 14 &15 at the Estancia La Jolla Hotel, is the only partnering meeting organized specifically for the regenerative medicine and advanced therapies industry.

The following are specific details regarding Histogen's presentation at the conference:

Event: Regen Med Partnering Forum - 2013 Stem Cell Meeting on the Mesa Date: October 14, 2013 Time: 3:15pm Location: Estancia La Jolla Hotel & Spa, 9700 North Torrey Pines Road, La Jolla

A live video webcast of all company presentations will be available at: stemcellmeetingonthemesa.com/webcast and will also be published on ARM's website shortly after the event. Histogen will also make a copy of Dr. Naughton's presentation available at http://www.histogen.com.

About Histogen Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit http://www.histogen.com.

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Stratus Media Group and Histogen Execute Letter of Intent for Biotechnology Merger

LOS ANGELES, October 07, 2013 - Stratus Media Group, Inc. (OTCQB:SMDI) announced today that it was planning to expand its entrance into the biotechnology industry with the execution of a letter of intent between the Company and Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer.

The non-binding letter of intent outlines the primary terms of a merger of San Diego-based Histogen into Stratus, to be renamed Restorgenex Corporation. The letter of intent has been approved by the board of directors of both companies, and the parties are engaged in completing a formal merger agreement.

Histogen's solutions are based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. The technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of proteins that have been shown to support stem cell growth and differentiation. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products.

"Histogen's technology platform opens a spectrum of potential product opportunities in both aesthetics and therapeutics, an ideal fit with our vision for Restorgenex," said Sol J. Barer, Ph.D., who will assume the position of Chairman of the Board of Restorgenex effective November 1, 2013. "The expertise of the Histogen team in developing regenerative products from concept to market, along with the success Histogen has already found in skincare partnering, will add significant value to our Company."

Following successful completion of this proposed merger, the company's goal is to build Restorgenex into a world-class cosmeceutical and pharmaceutical company in the large and expanding fields of dermatology and hair restoration. The parties intend to move toward a formal merger agreement in which Histogen would become a wholly-owned subsidiary, Histogen founder Gail K. Naughton, Ph.D. would assume the position of Chief Executive Officer of Restorgenex, and the corporate headquarters of Restorgenex would be located in San Diego. The merger will require, among other things, the satisfaction of customary closing conditions including the approval of Histogen's shareholders.

"I am very excited about the potential of a merger between Histogen and Restorgenex, and look forward to moving into the next stage," said Dr. Naughton. "It is an honor to be working with biotechnology visionaries Dr. Sol Barer and Isaac Blech, and to have them recognize the promise of Histogen's products is a true testament to the unique and exciting nature of our technology."

Dr. Naughton has spent more than 25 years extensively researching the tissue engineering process, holds more than 95 U.S. and foreign patents, and has been honored for her pioneering work in the field by prestigious organizations including receiving the Intellectual Property Owners Association Inventor of the Year Award.

Prior to founding Histogen in 2007, Dr. Naughton oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four human cell-based products from concept through FDA approval and market launch as President of Advanced Tissue Sciences.

"I believe the potential acquisition of Histogen, and the expertise and vision Dr. Naughton will bring as Chief Executive Officer will be a tremendous asset in ushering the Company into the biotechnology industry," said Jerold Rubinstein, current Chairman and Chief Executive Officer of Stratus.

http://www.histogen.com http://www.stratusmediagroup.com

Forward-Looking Statements Statements in this press release relating to plans, strategies, projections of results, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Securities Acts of 1933 and 1934. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors. Although the company's management believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, performance or achievements. The company has no obligation to update these forward-looking statements.

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I received a disturbing call from a woman in Texas recently. She was having some complications from the stem cell treatment that she received in her hometown.

In what is becoming a more common email or call from people not our patients, she revealed that she believed that her doctor was inexperienced in the Stem Cell procedure and did not know how to address her complications.

Even though I did not have the luxury of examining her, I tried to ask some questions to help her with her situation.

It seems, that she had received placental cells.They were injected into her knee and it caused a severe inflammatory response that left her with a great deal of pain. I did wish her the best and try to offer some advice, but also let her know that it is not legal nor recommended to inject placental cells into a patient.

While we have found the use of stem cells for the symptomatic treatment of arthritis and pain to be very helpful in our practice, one must be very cautious as to know what they are receiving.

As I mentioned, placental cells are not only illegal, but are immature cells that can have mutagenic properties. That is, they have the ability to turn into cancer cells and furthermore it is uncertain if the body can reject them since they are not harvested from the person who is receiving the treatment. These cells, also differentiate to form both blood cells and tissue cells so there is a great deal of insufficiency if you are looking to heal damaged tissue.

Bone marrow derived stem cells also have this same property of containing cell lines that turn into blood cells. There are certain areas, like the tibia, where the bone marrow contains many more blood cells then areas such as the hip, which contain more mesenchymal cells. Certain doctors have recommended tibial bone marrow draws for the use of bone marrow prolotherapy from the tibia, but this has very little scientific backing to be included as a stem cell source. There is also no research whatsoever showing its efficacy.

Many other doctors use bone marrow from the hip in their stem cell procedure. While this is a richer source of mesenchymal cells when compared to the tibia it is still a very poor source of stem cells.

Results from stem cell procedures not only depend on the cell type and where they are injected, but also the diagnostic skill and approach of the physician. While stem cells may have amazing properties, they are not so magical where we can just inject stem cells into a joint and hope for good results. As a physician, it is our job to evaluate and treat any problem surrounding, above and below the joint using a very careful physical examination. A comprehensive approach, not a single sided approach, will yield the best results for the patient.

Growth hormone has also been touted by one physician as useful in a stem cell mixture. That physician is conducting a study on this, but it still remains unproven. We had used this in power injection solution well over 10 years ago and stopped because it did not produce any significant clinical benefit. Furthermore, stem cells do need to be combined with a variety of growth factors in order to further their differentiation into new tissue. This can be achieved by using specialized forms of PRP along with the stem cell mixture. Both ourselves with our partners at Kensey and Dr. Centeno from Regenexx has done laboratory tests to look at the importance of this. There is a large variation in how stem cells perform based upon the environment that they are given with the PRP.

In summary, while these procedures have tremendous potential, we need to follow in the best of our knowledge base and follow our outcomes. Eventually, our technology will expand, and in the future we will have the capability to harvest stem cells in less than a half hour But this will take several years of development.

Scott Greenberg MD

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Stem Cell Therapy dangers and risks the wrong stem cells

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Icahn School of Medicine at Mount Sinai - New York City ...

A human embryo can split into twins or triplets until about 14 days after fertilization

Egg and sperm: some people believe an embryo must be fully protected from conception onwards (Wellcome Images/Spike Walker)

Human blastocyst on the tip of a pin: embryonic stem cells can be grown from cells found in the blastocyst (Wellcome Images/Yorgos Nikas)

Some people think an embryo deserves special protection from about 14 days after fertilization

Many patients could one day benefit from embryonic stem cell research

The rules controlling embryonic stem cell research vary around the world and have been the topic of much discussion

Embryonic stem cell research poses a moral dilemma. It forces us to choose between two moral principles:

In the case of embryonic stem cell research, it is impossible to respect both moral principles.To obtain embryonic stem cells, the early embryo has to be destroyed. This means destroying a potential human life. But embryonic stem cell research could lead to the discovery of new medical treatments that would alleviate the suffering of many people. So which moral principle should have the upper hand in this situation? The answer hinges on how we view the embryo. Does it have the status of a person?

Chapter 1 of this film introduces some of the key ethical arguments. Watch this film and others on our films page.

The moral status of the embryo is a controversial and complex issue. The main viewpoints are outlined below.

1. The embryo has full moral status from fertilization onwards Either the embryo is viewed as a person whilst it is still an embryo, or it is seen as a potential person. The criteria for personhood are notoriously unclear; different people define what makes a person in different ways.

Development from a fertilized egg into to baby is a continuous process and any attempt to pinpoint when personhood begins is arbitrary. A human embryo is a human being in the embryonic stage, just as an infant is a human being in the infant stage. Although an embryo does not currently have the characteristics of a person, it will become a person and should be given the respect and dignity of a person.

An early embryo that has not yet implanted into the uterus does not have the psychological, emotional or physical properties that we associate with being a person. It therefore does not have any interests to be protected and we can use it for the benefit of patients (who ARE persons).

The embryo cannot develop into a child without being transferred to a womans uterus. It needs external help to develop. Even then, the probability that embryos used for in vitro fertilization will develop into full-term successful births is low. Something that could potentially become a person should not be treated as if it actually were a person

2. There is a cut-off point at 14 days after fertilization Some people argue that a human embryo deserves special protection from around day 14 after fertilization because:

3. The embryo has increasing status as it develops An embryo deserves some protection from the moment the sperm fertilizes the egg, and its moral status increases as it becomes more human-like.

There are several stages of development that could be given increasing moral status:

1. Implantation of the embryo into the uterus wall around six days after fertilization. 2. Appearance of the primitive streak the beginnings of the nervous system at around 14 days. 3. The phase when the baby could survive if born prematurely. 4. Birth.

If a life is lost, we tend to feel differently about it depending on the stage of the lost life. A fertilized egg before implantation in the uterus could be granted a lesser degree of respect than a human fetus or a born baby.

More than half of all fertilized eggs are lost due to natural causes. If the natural process involves such loss, then using some embryos in stem cell research should not worry us either.

We protect a persons life and interests not because they are valuable from the point of view of the universe, but because they are important to the person concerned. Whatever moral status the human embryo has for us, the life that it lives has a value to the embryo itself.

If we judge the moral status of the embryo from its age, then we are making arbitrary decisions about who is human. For example, even if we say formation of the nervous system marks the start of personhood, we still would not say a patient who has lost nerve cells in a stroke has become less human.

If we are not sure whether a fertilized egg should be considered a human being, then we should not destroy it. A hunter does not shoot if he is not sure whether his target is a deer or a man.

4. The embryo has no moral status at all An embryo is organic material with a status no different from other body parts.

Fertilized human eggs are just parts of other peoples bodies until they have developed enough to survive independently. The only respect due to blastocysts is the respect that should be shown to other peoples property. If we destroy a blastocyst before implantation into the uterus we do not harm it because it has no beliefs, desires, expectations, aims or purposes to be harmed.

By taking embryonic stem cells out of an early embryo, we prevent the embryo from developing in its normal way. This means it is prevented from becoming what it was programmed to become a human being.

Different religions view the status of the early human embryo in different ways. For example, the Roman Catholic, Orthodox and conservative Protestant Churches believe the embryo has the status of a human from conception and no embryo research should be permitted. Judaism and Islam emphasize the importance of helping others and argue that the embryo does not have full human status before 40 days, so both these religions permit some research on embryos. Other religions take other positions. You can read more about this by downloading the extended version of this factsheet below.

Extended factsheet with a fuller discussion of the issues by Kristina Hug (pdf) EuroStemCell film "Conversations: ethics, science, stem cells" EuroStemCell factsheet on ethical issues relating to the sources of embyronic stem cells EuroStemCell factsheet on the science of embryonic stem cells EuroStemCell FAQ on human embryonic stem cells and their use in research EuroStemCell summaries of regulations on stem cell research in Europe Booklet for 16+ year olds about stem cells and ethics from the BBSRC Research paper on the ethics of embryonic stem cell research by Kristina Hug

This factsheet was created by Kristina Hug and reviewed by Gran Hermern.

Images courtesy of Wellcome Images: Egg and sperm by Spike Walker; Blastocyst on pin by Yorgos Nikas; Diabetes patient injecting insulin by the Wellcome library, London.

Other images from "Conversations : ethics, science, stem cells", a film by EuroStemCell.

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Embryonic stem cell research: an ethical dilemma | Europe ...

Sports and exercise are great ways to stay healthy, challenge yourself and have fun. So when an injury sidelines you, you want doctors with the expertise to get you back in the game as quickly as possible.

Youll find that expertise at Rush, home to the team physicians for the Chicago White Sox, Chicago Bulls, DePaul University Blue Demons, U.S. soccer and rugby, Hubbard Street Dance Company, and many other teams, schools and organizations.

Sports medicine physicians at Rush diagnose and treat athletes of all ages from weekend warriors to pro athletes and have the know-how to treat even the most complex injuries. They strive to relieve your pain and restore function, whether you're suffering from a throwing injury, "jumper's knee," a stress fracture, a muscle strain or tear, or another problem.

These highly-skilled specialists have pioneered numerous treatments for sports injuries, including cartilage transplants and arthroscopic surgical approaches for ACL and rotator cuff repair. They also have extensive experience evaluating and treating failed knee and shoulder surgeries, and performing shoulder replacement.

Sports injuries can happen any time of day. And when it comes to orthopedic injuries, you don't want to spend hours sitting in the ER. Now, you can get prompt medical care for your injury at the Sports Injury Immediate Care Clinic at Rush, with two convenient locations: downtown and in Westchester.

Staffed by board certified sports medicine doctors, the clinics are open until 7 p.m. on weeknights and from 8 a.m. to noon on Saturdays for immediate treatment including X-rays, bracing and casting or consultation.

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Sports Medicine Program - Rush University Medical Center

Are applicants for a driver's license asked questions about diabetes?

The driver's license application (first-time and renewal) asks an applicant whether he or she has, within the past six months, had a physical or mental condition that affected his or her ability to drive and if, within the past six months, he or she has had a fainting spell, blackout, seizure, or episode of loss of consciousness. If an applicant answers yes to either of these questions, he or she is required to have a physician complete an examination and submit a medical evaluation form before he or she may be licensed. See generally Mich. Admin. Code r. 257.853(1), (3) (2013) (requiring statement of physical history before licensing if reason to believe physical disability affects safe driving).

What other ways does the state have to find out about people who may not be able to drive safely because of a medical condition?

The state accepts reports of potentially unsafe drivers from police officers, the courts, physicians, family members, friends, other citizens, and hospitals. The licensing agency does not accept anonymous reports and investigates the source of a report if the source's relationship to the driver is not clear. See Mich. Comp. Laws 257.309(1) (2013) (licensing agency may refuse to grant a license without an examination based on information of physical condition received from any source). A concerned third party may make a report by submitting a Request for Driver Evaluation (OC-88) form. This report must contain identifying information about the driver, as well as specific information to justify the reevaluation of his or her driving ability. See Mich. Dept. of State, "Request for Driver Evaluation," Form OC-88 (Rev. 09/11). Drivers also may be required to have medical evaluations if they have impairments which are observed by licensing agency personnel during the licensing process, Mich. Comp. Laws 257.309(1) (2013), if they have been involved in at-fault crashes involving a fatality, have accumulated significant numbers of accidents or points during a two-year period, or when driving privileges are to be restored following a revocation or suspension. See Mich. Comp. Laws 257.320(1)(a)-(e) (2013).

What is the process for medical evaluations of drivers?

When the licensing agency has reason to believe that a driver may be medically unqualified to operate a motor vehicle, either because the driver gave positive answers to medical questions on the license application or because of a report from one of the other sources listed above, it will require the driver to submit to a medical evaluation. Mich. Comp. Laws 257.320(1)(a) (2013); Mich. Admin. Code r. 257.853(1) (2013). When this happens, a medical evaluation form is sent to the individual, which must be completed, in part, by his or her physician. See Mich. Admin. Code r. 257.853(6)-(9) (2013) (setting forth standards for physician's statement). The Physician's Statement of Examination must be returned to the licensing agency, where it is evaluated and a licensing decision is made. See Mich. Admin. Code r. 257.853(1), (3) (2013).

The Physician's Statement of Examination (DI4P) asks the driver to indicate whether he or she has diabetes. See Mich. Dept. of State, "Physician's Statement of Examination," Form DI-4P (03/05/2013). It also asks about seizures, blackouts, or fainting. Id. The driver must explain any of the conditions listed. Further questions relate to the number of accidents or incidents of lost consciousness within the last five years, and current medications being taken. Id. The physician must indicate if they have concerns about the driver's ability to operate vehicle, and why. Id. A full section asks detailed questions about medical conditions, prescribed medicine, control of condition, and episodes of lost consciousness. Id. Finally, the physician must indicate whether restrictions or further evaluations should be conducted. Id.

The licensing agency may request additional medical information from the physician or order further tests before making a decision. Mich. Admin. Code r. 257.853(9) (2013). Periodic follow-up medical evaluations may be required. Mich. Admin. Code r. 257.853(10) (2013).

Are physicians required by law to report drivers who have medical conditions that could affect their ability to drive safely?

There is no statutory authority requiring physicians to report drivers with medical conditions that could affect their ability to drive safely to a central state agency. Physicians and optometrists may voluntarily report a patient's physical qualifications to safely operate a vehicle. Mich. Comp. Laws 333.5139(1) (2013).

Are physicians who report drivers with medical conditions immune from legal action by the patient?

Yes. Physicians and optometrists are immune from civil and criminal liability for making a report, so long as they are acting in good faith and exercising due care. Mich. Comp. Laws 333.5139(3) (2013). Conversely, a physician who voluntarily chooses not to make a report is also immune from any liability for any subsequent injuries caused by the unsafe driver. Mich. Comp. Laws 333.5139(1) (2013).

Who makes decisions about whether drivers are medically qualified?

Licensing decisions are made by staff in the licensing agency's medical unit after reviewing an individual's medical information and giving strong consideration to the opinion of his or her physician. Mich. Comp. Laws 257.320(2) (2013) (licensing agency has authority to restrict, suspend, or revoke license). The licensing agency may appoint health consultations, Mich. Admin. Code r. 257.852 (2013), and has created a Medical Advisory Board. An expert in endocrinology may be a health consultant. Mich. Admin. Code r. 257.852(2)(n) (2013). The health consultants may advise the department concerning physical and mental standards for motor vehicle licensing. Mich. Admin. Code r. 257.852(3) (2013). Upon request, the consultants may advise the department concerning an applicant's or licensee's physical or mental ability to drive motor vehicle. Mich. Admin. Code r. 257.852(4) (2013). Nevertheless, the opinions of health consultants are advisory and the licensing agency retains ultimate authority over licensing decisions. Mich. Admin. Code r. 257.852(5) (2013). For more information, see Michigan Secretary of State, "(Terri Lynn) Land Creates Medical Advisory Board." (describing creation of Medical Advisory Board).

What are the circumstances under which a driver may be required to undergo a medical evaluation?

A driver may be required to undergo a medical evaluation if the licensing agency has reason to believe that he or she has a physical or mental disability that affects his or her ability to safely operate a motor vehicle. Mich. Comp. Laws 257.320(1)(a) (2013); Mich. Admin. Code r. 257.853(3) (2013). These reasons may include observation by licensing agency staff. Mich. Comp. Laws 257.320(1) (2013). The licensing agency may also consider information from a Request for Driver Evaluation (OC-88) submitted by a physician or optometrist or any other concerned third party. Mich. Comp. Laws 257.320(3) (2013) (physician or optometrist report should be considered for examination). A driver may also be required to undergo a medical evaluation for driving violations: 1) if he or she has in one or more instances been involved in an accident resulting in the death of a person; 2) he or she, within a 24-month period, has been involved in three accidents resulting in personal injury or damage to the property of a person for moving violations; 3) he or she has charged against him or her a total of 12 or more points within a period of two years; or 4) he or she has been convicted of violating restrictions, terms, or conditions of his or her license. Mich. Comp. Laws 257.320(1)(b)-(e) (2013); see also Mich. Comp. Laws 257.320a (2013) (providing for point system for various driving violations).

Has the state adopted specific policies about whether people with diabetes are allowed to drive?

No. Michigan has adopted no specific medical guidelines related to diabetes, except for its guidelines related to episodes of loss of consciousness. However, the Physician Examination form specifically asks the driver whether he or she has diabetes. Mich. Dept. of State, "Physician's Statement of Examination," Form DI-4P (03/05/2013).

What is the state's policy about episodes of altered consciousness or loss of consciousness that may be due to diabetes?

If an applicant or a licensee experiences an "episode," his or her license will be denied or indefinitely suspended after reexamination. Mich. Admin. Code r. 257.854(1) (2013). An episode is defined as any "condition which causes or contributes" to lapse of consciousness, blackout, seizure, fainting spells, syncope, or other impairments of the level of consciousness. Mich. Admin. Code r. 257.851(1)(e)(i)-(ii) (2013). It also includes any condition which causes or contributes to "violent or aggressive action" related to driving a motor vehicle. Mich. Admin. Code r. 257.851(1)(e)(iii) (2013). In order to regain his or her license, the driver must submit a Physician's Statement of Examination (DI-4P). Mich. Admin. Code r. 257.854(1) (2013). The physician must certify that the driver's condition is under control by medical or other treatment. All symptoms or conditions which would affect safe driving must have been controlled for at least 6 months. Mich. Admin. Code r. 257.854(2)(a) (2013). The physician must certify that the individual has not experienced an episode of loss of consciousness within the previous 6 months. Mich. Admin. Code r. 257.854(2)(b) (2013); see also Mich. Admin. Code r. 257.853(4)-(8) (2013) (specifying what information the Physician's Statement of Examination must contain). For chauffeurs and persons endorsed to operate trucks or buses, the requirements of the Physician's Statement of Examination are identical with the exception that the relevant episode-free period is 12 months. Mich. Admin. Code r. 257.854(3)(a)-(b) (2013). The licensing agency may require that an individual submit periodic follow-up medical evaluations as a condition of licensure. Mich. Admin. Code r. 257.853(10) (2013).

Does the state allow for waivers of this policy, e.g., a waiver for a one-time episode of severe hypoglycemia that has mitigating factors (e.g., recent change in medication, illness, etc.) or that has been addressed with a physician?

Yes. The 6-month or 12-month period may be reduced or eliminated based upon a departmental review of the specific recommendation of a qualified physician or any other information that may come to the licensing agency, including evidence that the episode of loss of consciousness resulted from medical intervention or medically supervised experimentation with prescribed medication, as well as the evaluation of other evidence. Mich. Admin. Code r. 257.854(4) (2013). Additionally, the licensing agency maintains that any action taken on the basis of a physical or mental condition or disability will be reassessed upon receipt of new medical evidence and documentation that the condition or disability has changed or abated or no longer exists. Mich. Admin. Code r. 257.853(11) (2013). All medical information submitted is reviewed by licensing agency personnel and at times in consultation with the Medical Advisory Board.

What is the process for appealing a decision of the state regarding a driver's license?

A driver may seek appeal to the licensing agency's administrative hearing officer or the circuit court. See Mich. Comp. Laws 257.322-.323 (2013); see also Mich. Admin. Code r. 257.856 (2013) (providing the right to appeal final decisions of the licensing agency). A request for an administrative hearing must be made in writing within 14 days of the denial or suspension of the license. Mich. Comp. Laws 257.322(2) (2013). To request a hearing, an individual may submit a Driver's License Appeals Hearing Request. At the hearing, an individual may present evidence and testimony, and before its commencement, the hearing officer may compel production of documents and transcripts of testimony. Mich. Comp. Laws 257.322(2)-(3) (2013). Following the hearing, the hearing officer may affirm, modify, or set aside the final determination of the licensing agency. Mich. Comp. Laws 257.322(5) (2013).

Alternately, an individual may request review of the licensing agency's decision in the circuit court of the county where the suspension or revocation was imposed or that of his or her residence by filing a petition within 63 daysor within 182 days with a showing of good cause. Mich. Comp. Laws 257.323(1) (2013). The court will set a date for a cause for hearing not more than 63 days after receipt of the petition for review. Mich. Comp. Laws 257.323(2) (2013). After presentation of evidence and testimony, the court will affirm, modify, or set aside the final determination of the licensing agency. Mich. Comp. Laws 257.323(3) (2013). The circuit court will not grant an individual restricted driving privileges, and it will set aside the licensing agency's final determination only if the petitioner's substantial rights have been prejudiced. Mich. Comp. Laws 257.323(4) (2013).

May an individual whose license is suspended or denied because of diabetes receive a probationary or restricted license?

Yes. The licensing agency may issue limited or restricted licenses or endorsements to individuals that have experienced episodes of loss of consciousness on a case-by-case basis. Mich. Admin. Code r. 257.854(4) (2013); see also Mich. Comp. Laws 257.312 (2013) (providing for restricted operator's and chauffeur's licenses); Mich. Admin. Code r. 257.3 (2013) (describing specific license restrictions).

Is an identification card available for non-drivers?

Yes, with proper identification and payment of a fee. Identification cards are issued at no charge to persons age 65 and over and to individuals whose licenses have been suspended due to medical reasons. See Mich. Dept. of State, "Driver's License or ID Requirements," Form SOS-428, (04/13). For more information, see Michigan Secretar of State, "Driver's License and State ID."

Resources

Driver licensing in Michigan is administered by the Department of State.

Read more:
Michigan: American Diabetes Association

Living with Diabetes

The Diabetes programs within MidMichigan Health help people with diabetes take control of their illness so they can live full and active lives here in the middle of Michigan.

Diabetes is a disease that prevents the body from correctly utilizing glucose the fuel that is made from the carbohydrates we eat. There are several types of diabetes:

Learn more about risk factors, symptoms and free screenings throughout the middle of Michigan

If you have diabetes, working with a team, including your physician, a diabetes nurse and a diabetes dietitian, will help you establish a plan for treatment.Learn more about the diagnosis and treatment of diabetes.

Diabetes is a risk factor for many other conditions and complications, including heart disease, eye problems, kidney disease, foot problems and depression. But there are many things you can do to manage your disease and prevent complications:

MidMichigan is committed to providing self-management tools to help you stay in control of your diabetes, including:

You may want to check with your insurance plan to see which programs and services are covered.

The diabetes education programs at MidMichigan Medical Centersin Clare,Gladwin, Midland, and MidMichigan Health ParkMt. Pleasant havebeenrecognized by the American Association of Diabetes Educatorsfor meeting national quality standards.These programs have also earned state certification by theMichigan Department of Community Health.

The diabetes instructors at the Diabetes Center of MidMichigan Medical Center in Midland arecertified diabetes educators (CDEs), which assures that they have met specific requirements of the National Certification Board of Diabetes Educators.

Diabetes services and programs are available in severallocations in central Michigan:

See the original post here:
Diabetes - MidMichigan Health

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Journal of Advanced Sciences Applied Engineering