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Friday, September 16, 2011

Commercial-stage Cell Therapy Companies and Products


Updated 2012-03-13 update

There are a number of products in the market which are made up entirely of cells or purport to have live cells in them and as such are included in our definition of cell therapy.

Some of these have received regulatory market approval.  However, a number of these products are being legally sold, even in highly regulated markets, without overt regulatory approval because they arguably meet the requirements set out for products which do not require such approval to be marketed.

Below is sample list of companies with cell therapy products* on the market in Europe, USA, or Japan.  In some instances there are reservations about whether or not these products still contain viable cells.  Our listing of these product is not an endorsement of their market claims nor of their strict regulatory compliance.

Company                                                    Product              
Advanced BioHealing (now part of Shire)    Dermagraft
AlloSource                                                 AlloStem
Altrika                                                        MySkin
Altrika                                                        CryoSkin
Alphatec Spine                                           PureGen
Amedica                                                     BioDfactor
Arthro Kinetics                                           CaReS
Avita Medical                                             ReCell® Spray-On Skin
Bio-Tissue                                                  Prokera
Bio-Tissue                                                  AmioGraft
BioTissue Technologies                               BioSeed-C
BioTissue Technologies                               chondrotissue
Cytori                                                         Celution System
Dendreon                                                   Provenge
euroderm                                                    Epidex
euroderm                                                    EpiGraft
Fidia Farmaceuitici                                      Hyalograft 3D
Fidia Farmaceuitici                                      Laserskin
Fidia Farmaceuitici                                      Hyalograft C
Fibrocell                                                      laViv
Genzyme (a Sanofi company)                      Epicel
Genzyme (a Sanofi company)                      Carticel
Genzyme (a Sanofi company)                      MACI Implant
Japan Tissue Engineering Co.                      J-TEC Epidermis
Japan Tissue Engineering Co.                      J-TEC Cartilage                                        
Japan Tissue Engineering Co.                      J-TEC Corneal Epithelium                        
Living Cell Technologies                              DIABECELL
NuTech                                                       NuCel
NuVasive                                                    Osteocel Plus
Organogenesis                                             Appligraf
Organogenesis                                             GINTUIT
Orthofix                                                      Trinity Evolution
TiGenix                                                       ChrondroCelect
Therakos                                                     Therakos Photopheresis

Most of these are only available in one or a few jurisdictions.  Sanofi's Genzyme products (Epicel & Carticel) are two of the few which are multi-nationally available.

South Korea is an interesting example of a country with a mature regulatory framework with more than its share of approval.  There have been 14 cell therapy products approved for sale in South Korea.  They are as follows:

Company                                                    Product    
Anterogen                                                  Adipocel
Anterogen                                                  Cupistem
Antrogen                                                    Queencell
Cellontech                                                  RMS ossron
Cellontech                                                  Chondron
Chabiotech                                                 Hyalgraft-3D+
Chabiotech                                                 Autostem
Creagene                                                    Creavax-RCC+
FCB-Pharmicell                                          Heartcellgram-AMI
Innocell                                                       Immuncell-LC+
Innomedisys                                                Innolak+
MCTT                                                        Keraheal+
Medipost                                                     Cartistem
NKBio                                                        NKM+
S-Bio Medics                                              Cureskin
Tegoscience                                                 Holoderm
Tegoscience                                                 Kaloderm

+ These products were brought to market in 2006-7 under a conditional approval unique to South Korea's regulation that allows commercial sale in certain instances while a pivotal trial is underway.

At present, the Korea-FDA is assessing a Biologics License Application (BLA) for CARTISTEM® being developed by Medipost. Once approved, CARTISTEM® will become available as the World's first hUCB-MSC derived adult stem cell drug for treating osteoarthritis and will be marketed in Korea in association with Dong-A pharmaceuticals

* This list does not purport to be exhaustive of all cell therapy products legally sold in these regions.  This list  does not include approved products in other highly-regulated jurisdictions, such as Australia, New Zealand, or Singapore, for example.  This list also excludes those cell-based treatments provided as a hospital or clinic-based service such as stem cell transplantation (hospital) or Regenexx (Regeneration Sciences, Inc.).

For the purposes of this list, “cell therapy” is defined loosely as any product which has in it live cells when administered to the patient including tissue transplants and devices.

Note that some of these products may be subject to emerging regulatory restrictions under the EMA ATMP regulations which may result in them having to be pulled from the market by the end 2012 at the latest.

Several of the products on this list did not receive overt regulatory approval but are being sold in regulated markets under exemption provisions which allow companies to bring cell therapy products to market which meet certain strict criterion.  At least a couple of the products listed are the subject of dispute between the company and the FDA or other regulatory agency as to whether or not they qualify under the 'exemptions'.

If you would like to suggest any revisions or additions to this list, please do so in the comment section below.

1 comment:

Afanasiefff said...

"Dendreon" and "Provenge" should be exchanged, Dendreon is the company.