StemCell Therapy

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What follows is the record of "classifications" done by the ATMP CAT in 2011 related to anything I would call "cell therapies". 


In my opinion there are a couple surprises. I'm surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I'm also surprised at the islets not being classified as an ATMP.


I've tapped into my European and/or regulatory colleagues to help explain those two as well as help us draw any other conclusions or observations we can make in terms of how the CAT is thinking based on the compendium of classifications we have to-date.  I'll post an update here when I have something useful.
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In January, the following product was classified as a tissue engineered product - not combined:

• Layer of autologous corneal epithelium containing stem cells intended for the treatment of extended corneal lesions

In April, the following product was classified as a tissue engineered product, combined: 

• Allogeneic human fibroblasts cultured onto a biodegradable matrix, intended for use of conditions in the therapeutic area of dermatology

In May, the following product was classified as a somatic cell therapy medicinal product: 

• Heterologous human adult liver-derived progenitor cells, intended for the treatment of inborn errors of liver metabolis

In July, the following product was classified as a Tissue Engineered Product, non-combined:

• Suspension of allogeneic bone-marrow derived osteoblastic cells, intended for the treatment of non-union, delayed union or other fractures. 

In September, the following product was classified as a Tissue Engineered Product, non-combined:

• Autologous mesenchymal stem cells (MSC), intended for the treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy

     and the following product was not classified as an ATMP: 

• Human islets of Langerhans, intended for: Post pancreatectomy for benign pancreatic pathologies (autologous); Treatment of severe forms of type 1 diabetes (Allogeneic)

In October, the following product was classified as a somatic cell therapy medicinal product: 

• Autologous dendritic cell (DCs) immunotherapy consisting of autologous mature DCs coelectroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA, intended for the treatment of patients with advanced renal cell carcinoma

In November, the following products were classified as tissue-engineered products:

• Concentrate of autologous bone marrow mononuclear cells (MNC), intended for improvement of heart function and quality of life in patients with chronic ischaemic heart disease and after MI.
• CD 133+ Autologous bone marrow derived stem cells, intended for Improvement of heart function (LVEF) and quality of life in patients with chronic ischemic heart disease and after MI

In December, the following product was classified as somatic cell therapy medicinal product:

• Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes, intended forthe treatment of autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection.

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CIRM has funded a $5.5 million Disease Team to develop a follow on clinical trial that uses a patient's own heart stem cells to regenerate scarred tissue damaged by a heart attack. The team is led by Eduardo Marban, MD, PhD, Director of the Cedars-Sinai Heart Institute

Read more:
Stem Cell Clinical Trial for Heart Failure: Eduardo Marban - CIRM Spotlight on Disease - Video

Direct Download http://www.ezdl.org In the first half, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr. Richard Burt at Northwestern University's School of Medicine has been successfully using patients own bone marrow stem cells to treat a variety of autoimmune diseases like Lupus, and Type 1 Diabetes.

Read the original post:
Coast To Coast AM: 15.11.2011 - Regenerative Medicine/ Dulce Base - Video

Following is a list of cell therapy products approved recently (2010-11):    

•  Dendreon                           Provenge                           US
•  FCB-Pharmicell                 Hearticellgram-AMI           Korea
•  Fibrocell Sciences              Laviv                                  US
•  Living Cell Technologies    DIABECELL                     Russia

 Honorable mention goes to TiGenix' ChondroCelect approved in late 2009 representing the first EMA approval of an ATMP:

• TiGenix                              ChondroCelect                   EU

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In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained formal regulatory market approval in some jurisdiction.


In the course of doing that work, I came across the following industry-sponsored phase III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III    

•     Aastrom              BRCs
•     Aldagen              ALD-101
•     Arblast               AMT-301
•     Avax                  Mvax
•     HepaLife Tech      HepaMate
•     KeraCure             KeraPac
•     t2cure                BMCs
•     TVAX                 TV-Brain
•     TVAX                 TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

•     ABH (now Shire)        Dermgraft
•     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

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

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Following is a list of cell therapy products approved recently (2010-11):    

•  Dendreon                           Provenge                           US
•  FCB-Pharmicell                 Hearticellgram-AMI           Korea
•  Fibrocell Sciences              Laviv                                  US
•  Living Cell Technologies    DIABECELL                     Russia

 Honorable mention goes to TiGenix' ChondroCelect approved in late 2009 representing the first EMA approval of an ATMP:

• TiGenix                              ChondroCelect                   EU

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

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

In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained formal regulatory market approval in some jurisdiction.


In the course of doing that work, I came across the following industry-sponsored phase III cell therapy trials which appear to be inactive and those which failed or were terminated.


INACTIVE INDUSTRY PHASE III    

•     Aastrom              BRCs
•     Aldagen              ALD-101
•     Arblast               AMT-301
•     Avax                  Mvax
•     HepaLife Tech      HepaMate
•     KeraCure             KeraPac
•     t2cure                BMCs
•     TVAX                 TV-Brain
•     TVAX                 TV-Kidney-1

   
RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

•     ABH (now Shire)        Dermgraft
•     Cellerix                    Cx401

I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

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

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

Major General James Gilman, Commanding General of the US Army Medical Research and Material Command, outlined the US army's extensive research efforts in stem cell technologies and their mission to discover, develop and translate regenerative medicine. He spoke about the military's desire to partner with academia and industry to generate effective treatments for volume, bone, muscle and tissue injuries and about spinal cord regeneration as the military's biggest challenge and hope.

See the article here:
2011 Summit: Harnessing Regenerative Medicine for US Service-members, Major General James K. Gilman - Video

INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

• 52% (12) are autologous
• 33% (7) are allogeneic
• Two are gene-modified allogeneic
• One involves autologous and allogeneic cells

• 24% (5) are for cardiac-related indications
• 33% (7) are for oncology or related indications
• Two are for cartilage repair

• Assistance Publique - Hôpitaux de Paris (France)
• Association of Dutch Burn Centres (Netherlands)
• Barts and The London NHS Trust (UK)
• Erasmus Medical Center (Netherlands)
• European Group for Blood and Marrow Transplantation (Europe)
• Leiden University Medical Center (Netherlands)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Ministry of Health (Malaysia)
• Royan Institute (Iran)
• Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
• Third Military Medical University (Chia)
• University of Minnesota, Masonic Cancer Center (US)
• University of Minnesota, Masonic Cancer Center (US)
• University Hospital of North Norway (Norway)
• University of Utah (US)

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INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

• 52% (12) are autologous
• 33% (7) are allogeneic
• Two are gene-modified allogeneic
• One involves autologous and allogeneic cells

• 24% (5) are for cardiac-related indications
• 33% (7) are for oncology or related indications
• Two are for cartilage repair

• Assistance Publique - Hôpitaux de Paris (France)
• Association of Dutch Burn Centres (Netherlands)
• Barts and The London NHS Trust (UK)
• Erasmus Medical Center (Netherlands)
• European Group for Blood and Marrow Transplantation (Europe)
• Leiden University Medical Center (Netherlands)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Ministry of Health (Malaysia)
• Royan Institute (Iran)
• Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
• Third Military Medical University (Chia)
• University of Minnesota, Masonic Cancer Center (US)
• University of Minnesota, Masonic Cancer Center (US)
• University Hospital of North Norway (Norway)
• University of Utah (US)

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William Bruyea, host of StemCellTV talks to Morrie Ruffin, co-founder and managing director of Alliance for Regenerative Medicine at the Meeting on the Mesa partnering forum at Sanford Consortium in La Jolla, CA. Morrie discusses regenerative medicine, stem cells and development.

Go here to read the rest:
StemCellTV Talks to Morrie Ruffin of Alliance for Regenerative Medicine at Meeting on the Mesa - Video

William Bruyea, host of StemCellTV talks to Michael Werner, co-founder and executive director of Alliance for Regenerative Medicine at the Meeting on the Mesa partnering forum at Sanford Consortium in La Jolla, CA. Michael discusses regenerative medicine, stem cells and development, and stem cell regulation.

See more here:
StemCellTV Talks to Michael Werner of Alliance for Regenerative Medicine at Meeting on the Mesa - Video

William Bruyea, host of StemCellTV talks to Elona Baum of the California Institute for Regenerative Medicine (CIRM) about the Meeting on the Mesa Partnering Event at Sanford Consortium and co-sponsoring with Alliance for Regenerative Medicine (ARM).

Originally posted here:
StemCellTV Talks to Elona Baum of the California Institute of Regenerative Medicine - Video

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I'm proud to use every available resource at our disposal, including this blog, to highlight the efforts of the charity we support - especially during this holiday season.  


I would be so delighted to have you join me in supporting Sabrina Cohen and her efforts.  You can start by buying next year's calendar!

The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   

--Lee


_________________________________________________________________

On the night of November 12, David Porosoff’s Artrageous Gallery hotspot was converted into something likely never imagined -- a hotbed of stem cell research.  Sabrina Cohen fused the vividly artistic backdrop and venue with gambling, cuban music, great food, and beautiful people all to further her mission of raising money and awareness for stem cell research.

Dr. Sally Temple with Sabrina Cohen

Dubbed the Havana Casino Night, the event had several highlights including the granting of the 2011 Sabrina Cohen Foundation award to stem cell researcher Dr. Sally Temple.  


Representing the 3rd recipient of the annual SCF award, Dr. Sally Temple is studying how neural progenitor cells may be employed to create cell-based therapies for neurodegenerative disorders.  Dr. Temple is the co-Founder and Scientific Director of the Neural Stem Cell Institute located in Rensselaer, NY.  NSCI is the first independent, non-profit stem cell research institute in the USA.


The night, sponsored in part by DMR, Evensky & Katz and Harke Clasby & Bushman, raised $10,000 which will be dedicated toward next year’s SCF Award for Stem Cell Research.  


The event also marked the lauch of the the Foundation’s 2012 CELLebrity Doctors Calendar, this year featuring women in the field of stem cell research.  The calendar features academics, industry executives, physicians, and advocates primarily from the United States but also representing Sweden, Australia and Canadian covergirl, Dr. Fiona Costello.


“In science you don't have to accept anything anyone tells you, you can come up with a hypothesis and test it yourself. And you can be the first one to do it,” says Dr. Costello, whose research focus is on multiple sclerolsis and other impairments of the central nervous system. 


“Stem cell science is often accused of being ‘hyped,” says Cohen, “but that doesn’t necessarily translate into monetary support for or society recognition of the enormous contributions made by stem cell resarchers.  They often toil in anonymity making significant discoveries at great personal sacrifice.  I consider it my job to find a way to financially support their work and bring profile to them as people.”  


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   


The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


Sabrina Cohen is the Executive Director and President of the foundation. She graduated from the University of Miami with a degree in Communications, double majoring in Advertising and Psychology, and holds a post-graduate degree in Copywriting from the Miami Ad School.  She is a C5 Quadriplegic, as the result of a spinal cord injury from a car accident in 1992. In 2006, she established SCF to raise funds for research because she believes the field of Regenerative Medicine will lead to the greatest advances of our time. Sabrina is a Motivational Speaker & Spokesperson continuously speaking in schools, universities and community centers. She has spoken at scientific conferences around the country, including the "World Stem Cell Summit" at the University of Wisconsin, Harvard University, Stanford University, Baylor College of Medicine at the University of Texas, and at the United Nations. Sabrina believes her wheelchair is a vehicle to promote change.  


Sabrina Cohen was recognized by WebMD Magazine as a 2009 "American Health Hero”.  Sabrina is currently available for interviews highlighting the 2012 “CELLebrity” Doctors Calendar.

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

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

Tweet 

I'm proud to use every available resource at our disposal, including this blog, to highlight the efforts of the charity we support - especially during this holiday season.  


I would be so delighted to have you join me in supporting Sabrina Cohen and her efforts.  You can start by buying next year's calendar!

The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   

--Lee


_________________________________________________________________

On the night of November 12, David Porosoff’s Artrageous Gallery hotspot was converted into something likely never imagined -- a hotbed of stem cell research.  Sabrina Cohen fused the vividly artistic backdrop and venue with gambling, cuban music, great food, and beautiful people all to further her mission of raising money and awareness for stem cell research.

Dr. Sally Temple with Sabrina Cohen

Dubbed the Havana Casino Night, the event had several highlights including the granting of the 2011 Sabrina Cohen Foundation award to stem cell researcher Dr. Sally Temple.  


Representing the 3rd recipient of the annual SCF award, Dr. Sally Temple is studying how neural progenitor cells may be employed to create cell-based therapies for neurodegenerative disorders.  Dr. Temple is the co-Founder and Scientific Director of the Neural Stem Cell Institute located in Rensselaer, NY.  NSCI is the first independent, non-profit stem cell research institute in the USA.


The night, sponsored in part by DMR, Evensky & Katz and Harke Clasby & Bushman, raised $10,000 which will be dedicated toward next year’s SCF Award for Stem Cell Research.  


The event also marked the lauch of the the Foundation’s 2012 CELLebrity Doctors Calendar, this year featuring women in the field of stem cell research.  The calendar features academics, industry executives, physicians, and advocates primarily from the United States but also representing Sweden, Australia and Canadian covergirl, Dr. Fiona Costello.


“In science you don't have to accept anything anyone tells you, you can come up with a hypothesis and test it yourself. And you can be the first one to do it,” says Dr. Costello, whose research focus is on multiple sclerolsis and other impairments of the central nervous system. 


“Stem cell science is often accused of being ‘hyped,” says Cohen, “but that doesn’t necessarily translate into monetary support for or society recognition of the enormous contributions made by stem cell resarchers.  They often toil in anonymity making significant discoveries at great personal sacrifice.  I consider it my job to find a way to financially support their work and bring profile to them as people.”  


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   


The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


Sabrina Cohen is the Executive Director and President of the foundation. She graduated from the University of Miami with a degree in Communications, double majoring in Advertising and Psychology, and holds a post-graduate degree in Copywriting from the Miami Ad School.  She is a C5 Quadriplegic, as the result of a spinal cord injury from a car accident in 1992. In 2006, she established SCF to raise funds for research because she believes the field of Regenerative Medicine will lead to the greatest advances of our time. Sabrina is a Motivational Speaker & Spokesperson continuously speaking in schools, universities and community centers. She has spoken at scientific conferences around the country, including the "World Stem Cell Summit" at the University of Wisconsin, Harvard University, Stanford University, Baylor College of Medicine at the University of Texas, and at the United Nations. Sabrina believes her wheelchair is a vehicle to promote change.  


Sabrina Cohen was recognized by WebMD Magazine as a 2009 "American Health Hero”.  Sabrina is currently available for interviews highlighting the 2012 “CELLebrity” Doctors Calendar.

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

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

William Bruyea, host of StemCellTV talks to Dr. Craig Saunders of Harmony Cosmetic Surgery in Keller, Texas about stem cells and regenerative medicine at the Evolution of Fat Workshop in Dallas, TX sponsored by Medical Alliance Services, distributor of Tickle Lipo.

Original post:
Dr. Craig Saunders Discusses Stem Cells and Regenerative Medicine at the Evolution of Fat Workshop - Video

DOWNLOAD LINK: adf.ly (CLICK ON "REGULAR DOWNLOAD" BUTTON FOR FREE DOWNLOAD) FOLLOW ON TWITTER: twitter.com SUBSCRIBE TO MY YOUTUBE CHANNEL: http://www.youtube.com REGISTER FOR HOTFILE ACCOUNT: hotfile.com REGISTER FOR FILESERVE ACCOUNT: http://www.fileserve.com http://www.coasttocoastam.com Date: 11-15-11 Host: George Noory Guests: Anthony F. Sanchez, Christian Wilde In the first half, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells

Original post:
Coast To Coast AM: Regenerative Medicine / Dulce Base 11-15-2011 Download Link - Video

(Part 6 of 9) David Hinton, Ph.D., spoke at the Scientific Writer's Seminar, a workshop presented on September 17, 2008 at CIRM headquarters in San Francisco. Hinton has a CIRM grant to study the therapeutic potential of retinal pigment epithelial cell lines derived from human embryonic stem cells for retinal degeneration. Hinton is a professor of pathology, neurosurgery, and ophthalmology at the Keck School of Medicine at the University of Southern California.

See the article here:
Stem Cell Based Therapies for Blindness: David Hinton - CIRM Science Writer's Seminar - Video

MP3 http://www.4shared.com Guests: Anthony F. Sanchez, Christian Wilde Regenerative Medicine: In the first half of Tuesday's show, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr.

More:
Coast To Coast AM - 15.11.2011 - 1/4 - Regenerative Medicine/Dulce Base - Video

Guests: Anthony F. Sanchez, Christian Wilde Regenerative Medicine: In the first half of Tuesday's show, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr

Continued here:
Coast To Coast AM - 15.11.2011 - 4/4 - Regenerative Medicine/Dulce Base - Video