ChondroCelect (characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins)
- Region
- 🇪🇺 EU
- Active substance
- characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
- Company
- TiGenix N.V.
- Status
- Withdrawn
- Therapeutic area
- Cartilage Diseases
- EU approval
- Mon 05 Oct 2009
- Designations
- ATMP
- Application
- EMEA/H/C/000878
- ATC
- M09AX02
- Official record
- www.ema.europa.eu
Indication
Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm².
Regulatory milestones
No milestones recorded in the last year.
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