Category Archives: Regenerative Medicine

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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.

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

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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.

Go here to read the rest:
Coast To Coast AM: 15.11.2011 - Regenerative Medicine/ Dulce Base - 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

Continue reading here:
Coast To Coast AM: 15.11.2011 - Regenerative Medicine/ Dulce Base - Video

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.

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

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.

Read the original post:
Stem Cell Clinical Trial for Heart Failure: Eduardo Marban - CIRM Spotlight on Disease - 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

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

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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

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

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

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.

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