Autologous cultured chondrocytes
As of the edition of 20 October 2026, Autologous cultured chondrocytes is a drug: marketed, first approved in 1997 (US); US protection ended in 2009.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Unknown
- Brand name
- Carticel Sm Service
- First approved
- 22 August 1997 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Vericel
- Withdrawn from market
- 1 July 2018 (in some regions)
- Registered trials
- 7, 1 stopped early
- Disease areas
- Bones, joints and muscles; Injuries; Skin and connective tissue
US protection
US protection ended in 2009.
US protection ended in 2009, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Vericel. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 3 | 4 | 1 | 2 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vericel | Applicant and Lead sponsor of trials | 1995 to now |