Stem cell therapeutic products on the market

by Alexey Bersenev on February 29, 2012 · 2 comments

in RegenMed digest

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Updated on Mar. 6, 2012

Last year I wrote about some regenerative medicine and cell therapy products on the market. You can find updated list here. But what is the value of stem cell products among all commercial cellular products? Because there is a big demand for this kind of information I’ve attempted to summarize it in a table. The table includes all (as I was able to capture) stem cell therapeutic products, available on the market worldwide.

Inclusion criteria:

  • Stem cell therapeutic product (drug) was defined as it claimed by a company or regulatory agency.
  • The product is authorized for sales and available on the market.
  • The product is approved and/or regulated by federal agency.

The list:
1. ReliNethra
Brand: Reliance Life Science
Country: India
Year or release: 2008
Regulation: unknown
Condition: eye diseases
Cell type: limbal stem cells
Donor type: autologous

2. CardioRel
Brand: Reliance Life Science
Country: India
Year or release: 2010
Regulation: unknown
Condition: post acute myocardial infarction
Cell type: BM MNC/ MSC
Donor type: autologous

3. Trinity Evolution
Brand: Orthofix
Country: USA
Regulation: FDA (HTC/P, 21 CFR, part 1271)
Condition: orthopedics
Cell type: bone matrix with MSC
Donor type: allogeneic

4. Osteocel Plus
Brand: NuVasive
Country: USA
Regulation: FDA (HTC/P, 21 CFR, part 1271)
Condition: orthopedics
Cell type: BM MSC
Donor type: allogeneic

5. HeartiCellGram-AMI
Brand: FCB PharmiCell
Country: S. Korea
Regulation: KFDA approved
Condition: post acute myocardial infarction
Cell type: BM MSC
Donor type: autologous
(Photo credit: Reuters/Jo Yong-Hak)

6. Cartistem
Brand: Medipost
Country: S. Korea
Regulation: KFDA approved
Condition: degenerative arthritis
Cell type: Umbilical cord MSC
Donor type: allogeneic

7. Cupistem
Brand: Anterogen
Country: S. Korea
Regulation: KFDA approved
Condition: anal fistula (Chron’s disease)
Cell type: Adipose MSC
Donor type: autologous

8. AlloStem
Brand: AlloSource
Country: US
Regulation: FDA (HTC/P, 21 CFR, part 1271)
Condition: orthopedics
Cell type: Bone matrix + BM MSC
Donor type: allogeneic

Abbreviations: FDA – Food and Drug Administration, KFDA – Korean FDA, MSC – mesenchymal stromal cells, BM – bone marrow, MNC – mononuclear cells.

Data access:
Free, public – everyone can view and edit.
link to the spreadsheet

How to cite: Bersenev Alexey. Stem cell therapeutic products on the market. Stem Cell Assays blog. February 29, 2012. Available: http://stemcellassays.com/2012/02/stem-cell-therapeutic-products-market/

This is a working community project. Please let me know if you have any additional information, which could be included.

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{ 2 comments… read them below or add one }

mahendra March 9, 2012 at 9:19 pm

LaViv from Fibrocell
Hemacord a cord blood derivative approved by US FDA
Dendreon- Provenge also approved

Reply

Alexey Bersenev March 11, 2012 at 4:12 pm

Mahendra,
I was capturing precisely “stem cell therapeutic products” commercialised worldwide. Not all “cell therapeutic products”. Laviv and Provenge are not stem cell products. Hemacord is still not clear to me (you can see Hamacord in my table shaded). Not clear because I’m not sure whether this product is commercial and on the market (anyone can buy it). It’s made by non-profit organization, not by a company. Even though Hemacord is a trade mark or label, it’s just a new standard for hematopoietic graft, enforced by US FDA. So, every public CB bank should have their own “Hemacord” in the future. Do you think should we classify these products as “stem cell therapeutic products on a market”?

For all “cell therapy” products on the market, Lee Buckler did a great work while ago –
http://celltherapyblog.blogspot.com/2011/09/commercial-stage-cell-therapy-companies.html
That’s why I decided to focus only on “stem cell products”. I roughly estimate that about 50 cell therapy products commercially available in the world. 8 of them are “stem cell products”.

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