autologous culture chondrocytes
Trade name: Carticel
Cell therapyapproved
Approved
Aug 22, 1997
Chondrocytes are the only cells found in healthy cartilage. They produce and maintain the cartilaginous matrix, which consists mainly of collagen and proteoglycans. Although the word chondroblast is commonly used to describe an immature chondrocyte, the term is imprecise, since the progenitor of chondrocytes can differentiate into various cell types, including osteoblasts. — Wikipedia
Clinical trial activity
30 trials · 39 clinical orgs · 1 marketing orgs
Phase 1
11
Phase 2
18
Phase 3
10
Phase 4
1
Earliest trial started May 1, 1999 (NCT00004487)
Timeline
1990s
- Aug 22, 1997
Earliest FDA Approval
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
2010s
- Dec 13, 2016
Vericel Corporation — First NDA Organization
- Dec 13, 2016
Vericel Corporation — NDA Organization
Indications
Approved for
Studied for
- Bone Cysts · Phase 1
- Cartilage · Phase 1
- Cartilage, Articular · Phase 4
- Cartilage Diseases · Phase 3
- Congenital Microtia · Early Phase 1
- Fractures, Bone · Phase 1
- Intervertebral Disc Degeneration · Phase 2
- Intervertebral Disc Displacement · Phase 1/Phase 2
- Joint Diseases · Phase 1/Phase 2
- Liver Cirrhosis · Phase 1
- Mandibular Condyle · Phase 2
- Nasal Septal Perforation · Phase 1
- Osteoarthritis, Hip · Phase 1
- Osteochondritis · Phase 3
- Osteochondritis Dissecans · Phase 3
- Temporomandibular Joint Disorders · Phase 1
- Traumatology · Phase 3
- Vesico-Ureteral Reflux · Phase 3
Mechanism of action
- Unspecified targetOTHER
May promote synthesis of hyaline-like cartilage repair tissue
- ChondrocyteSupplementation
Chondrocyte supplementation
Approval history
- approvedAug 22, 1997
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaChondrocyte ↗
- NCATSD5P3K3V822 ↗
- ChEMBLCHEMBL5315092 ↗
- WikipediaAutologous cultured chondrocytes on porcine collagen membrane ↗
Also known as
- autologous chondrocyte
- autologous chondrocytes
- autologous cultured chondrocytes
- autologous cultured chondrocytes
- autologous cultured chondrocytes
- autologous cultured chondrocytes
- carticel sm service
- chondrocytes
- spheroids of human autologous matrix-associated chondrocytes
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05553132 | Phase 1 | Dec 31, 2022 | Mayo Clinic |
| NCT04633928 | Phase 1 | Apr 9, 2021 | Dr Josef Vavrina, HNO Seepraxen, CH-8810 Horgen, Zurich, University of Basel |
| NCT04744402 | Phase 2 | Oct 28, 2020 | Biosolution Co., Ltd. |
| NCT05051332 | Phase 3 | Mar 19, 2020 | Biosolution Co., Ltd., Catholic University of Korea, Chonnam National University, Chosun University, Chungnam National University, Ewha Womans University, Inje University, Korea University, Kosin University, Kyung Hee University, Pusan National University, Seoul National University, Sungkyunkwan University, Yonsei University |
| NCT03588975 | Phase 3 | Jul 31, 2018 | Vericel Corporation |
| NCT03319797 | Phase 3 | Oct 10, 2017 | Orthopaedic Surgery Munich, Tetec AG |
| NCT04296487 | N/A | Sep 1, 2017 | University of Lausanne |
| NCT03137914 | Phase 1 | May 8, 2015 | Faculdade de Medicina de Petrópolis Faculdade Arthur Sá Earp Neto, Faculty of Medicine of Petrópolis |
| NCT03545269 | Phase 2 | Feb 3, 2014 | Biosolution Co., Ltd., Ewha Womans University, Kyung Hee University, Yonsei University |
| NCT01957722 | Phase 3 | Jan 1, 2014 | Aesculap AG |
| NCT01656902 | Phase 3 | Jan 1, 2013 | Tetec AG |
| NCT01771471 | Phase 2 | Nov 1, 2012 | Carolina Neurosurgery and Spine Associates, ISTO Technologies, Inc. |
| NCT01640457 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2012 | Medical University Innsbruck, Tetec AG, University of Halle |
| NCT03517046 | Phase 1 | Jul 17, 2012 | Biosolution Co., Ltd., Kyung Hee University |
| NCT01694823 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2012 | Air Force Military Medical University, China, People's Liberation Army of China |
| NCT02770209 | N/A | Feb 1, 2012 | People's Liberation Army of China |
| NCT01400607 | Phase 3 | Jul 1, 2011 | ISTO Technologies, Inc. |
| NCT01500811 | Phase 1 | Mar 1, 2011 | Royan Institute |
| NCT01225575 | Phase 2 | Oct 1, 2010 | co.don AG, University of Mannheim |
| NCT01222559 | Phase 3 | Oct 1, 2010 | co.don AG, University of Mannheim |
Showing 20 of 30 trials
Page 1 / 2
Organizations
Research & Development (39)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Biosolution Co., Ltd. | For profit | 4 | 4 | 3 | 2012 |
| Royan Institute | Academic/Hospital | 4 | 4 | 1 | 2009 |
| Kyung Hee University | Academic/Hospital | 3 | 0 | 3 | 2012 |
| Tetec AG | For profit | 3 | 3 | 2 | 2012 |
| Vericel Corporation | For profit | 3 | 3 | 2 | 2000 |
| co.don AG | For profit | 2 | 2 | 2 | 2010 |
| Ewha Womans University | Academic/Hospital | 2 | 0 | 2 | 2014 |
| Genzyme | For profit | 2 | 0 | 2 | 2000 |
| Histogenics Corporation | For profit | 2 | 2 | 2 | 2006 |
| ISTO Technologies, Inc. | For profit | 2 | 2 | 2 | 2011 |
| People's Liberation Army of China | Government | 2 | 1 | 2 | 2012 |
| University of Mannheim | Academic/Hospital | 2 | 0 | 2 | 2010 |
| Yonsei University | Academic/Hospital | 2 | 0 | 2 | 2014 |
| Aesculap AG | For profit | 1 | 1 | 1 | 2014 |
| Air Force Military Medical University, China | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Carolina Neurosurgery and Spine Associates | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Catholic University of Korea | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Chonnam National University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Chosun University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Chungnam National University | Academic/Hospital | 1 | 0 | 1 | 2020 |
39 organizations
Page 1 / 2
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Vericel Corporation | For profit | NDA | Dec 13, 2016 |