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Table 2 Products currently approved or undergoing clinical trials of cell-based products for cartilage repair

From: Insights into the present and future of cartilage regeneration and joint repair

Product Allogeneic /autologous Market Status Indication Cell source Delivery method Clinical trial number Ref.
Chondrocytes, allogeneic        
Invossa / TissueGene-C Allogeneic Phase III underway in the US, withdrawn in KR Knee Osteoarthritis Juvenile chondrocytes and transduced cells expressing TGF-B1 Intraarticular Injection US Phase III NCT03203330 (Clinicaltrials.gov, 2017; Evans, 2019)
Chondrocytes, autologous        
Chondron Autologous Approved in KR in 2001 Focal knee cartilage defect and arthritis chondrocytes from patient joint Cell suspension to be implanted with fibrin glue during arthrotomy KR Follow up NCT01056900 (Ministry of Food and Drug Safety, 2019; Clinicaltrials.gov, 2010a)
JACC Autologous Approved in JP 2012 traumatic cartilage defect, Osteochondritis dissecans chondrocytes from patient joint Cells embedded in atelocollagen gel implanted with periosteal flap JP study J-TEC002 (Ministry of Health, Labour and Welfare, 2012)
MACI Autologous Approved in US 2016, EU in 2013, withdrawn 2018 Articular Cartilage Defect chondrocytes from patient joint Cell-seeded collagen membrane secured with fibrin glue during mini-arthrotomy US Phase III NCT00719576 (Food and Drug Administration, 2021; European Medicines Agency, 2018; Clinicaltrials.gov, 2008)
Ortho-ACI Autologous Approved in AU in 2017 Articular Cartilage Defects, knee, patella, ankles Chondrocytes from patient joint Cells and collagen scaffold implanted arthroscopy None found (Department of Health Therapeutic Good Administration, 2017)
Spherox Autologous Approved in EU 2017 Articular Cartilage Lesion of the Femoral Condyle chondrocytes from patient joint Spheroids of autologous matrix-associated chondrocyte implanted during arthroscopy or mini-arthrotomy EU Phase III NCT01222559 (European Medicin Agency, 2021; Clinicaltrials.gov, 2010b)
Novocart 3D Autologous Approved in DE and CH in 2014, phase III in US and EU Traumatic Articular Cartilage Defects in the Knee chondrocytes from patient joint Cells within bilayer collagen sponge implanted during arthrotomy US Phase III NCT01957722
EU Phase III NCT01656902
(Paul Ehrlich Institut German Federal Ministry of Health, 2014; Swissmedic Swiss Agency for Therapeutic Products, 2014; Clinicaltrials.gov, 2013a)
CartiLife Autologous Approved in KR, Phase II underway in the US Articular Cartilage Defect and Degeneration Costal autologous chondrocytes Pellet-cultured beads fixed with fibrin glue during arthrotomy KR Phase II NCT03545269
Phase II US NCT04744402
(Ministry of Food and Drug Safety, 2019; Clinicaltrials.gov, 2021; Clinicaltrials.gov, 2018a)
Stem Cells, allogeneic        
Cartistem Allogeneic Approved in KR in 2012, Phase I/II a completed in the US Cartilage Injury, Osteoarthritis umbilical cord derived MSCs and sodium hyaluronate During arthroscopy into holes drilled into defects KR Phase III NCT01041001
US Phase I/II NCT01733186
(Clinicaltrials.gov, 2012; Clinicaltrials.gov, 2009)
CYP-004 Allogeneic Phase III trial underway in AU Knee OA iPSC derived MSCs Intraarticular Injection AU Phase III ACTRN12620000870954 (Australian New Zealand Clinical Trial Registry, 2020)
Chondrogen Allogeneic Phase II underway in MY Knee OA Umbilical cord derived MSCs and HA Intraarticular Injection MY Phase II NCT04520945 (Clinicaltrials.gov, 2020a)
AlloJoin Allogeneic Phase II underway in CN Knee OA Adipose-derived mesenchymal progenitor cells Intraarticular Injection CN Phase II NCT04208646 (Clinicaltrials.gov, 2019a)
CELLISTEM-OA Allogeneic Phase I/II underway in CL Knee OA Umbilical-cord derived MSCs Intraarticular Injection CL Phase I/II NCT03810521 (Clinicaltrials.gov, 2019b)
Chondrochymal Allogeneic Phase I/II underway in TW Knee OA Bone marrow derived MSCs Intraarticular Injection TW Phase I/II NCT03589287 (Clinicaltrials.gov, 2018b)
Elixcyte Allogeneic Phase I/II underway in TW Knee OA Adipose-derived MSCs Intraarticular Injection TW Phase I/II NCT02784964 (Clinicaltrials.gov, 2016)
MAG200 Allogeneic Phase I completed in AU Bilateral Primary OA of Knee Adipose-derived MSCs Intraarticular Injection AU Phase I ACTRN12617001095358 (Registration number ACTRN12617001095358, 2018)
Progenza Allogeneic Phase I completed in AU Knee OA Adipose-derived MSCs plus MSC secretions Intraarticular Injection AU Phase I ACTRN12615000439549 (Australian New Zealand Clinical Trial Registry, 2018)
SMUP-IA-01 Allogeneic Phase I in KR completed Knee OA umbilical cord derived MSCs Intraarticular Injection KR Phase I NCT04037345 (Clinicaltrials.gov, 2019c)
Stem Cells, autologous        
JOINTSTEM Autologous Phase III completed KR, Phase II/III in US underway Degenerative Arthritis Knee Osteoarthritis Adipose-derived MSCs Intraarticular Injection KR Phase III NCT03990805
US PhaseII/III NCT04368806
(Clinicaltrials.gov, 2019d; Clinicaltrials.gov, 2020b)
AdMSCs Autologous Phase II underway in the US Osteoarthritis, Knee, Hip, Shoulder Adipose-derived MSCs Intraarticular Injection and intravenous infusion US Phase II NCT04448106 (Clinicaltrials.gov, 2020c)
ReJoin Autologous Phase II completed in CN Knee Osteoarthritis adipose-derived mesenchymal progenitor cells Intraarticular Injection CN Phase II NCT01809769 (Clinicaltrials.gov, 2013b)
Stemchymal OA Knee Autologous Phase I/II underway in TW Knee OA Adipose-derived MSCs Intraarticular Injection TW Phase I/II NCT02544802 (Clinicaltrials.gov, 2015)
PSC-01 Autologous Phase I underway in the US Knee OA Adipose-derived MSCs Intraarticular Injection US Phase I NCT04043819 (Clinicaltrials.gov, 2019e)
  1. Products currently approved or undergoing clinical trials of cell-based products for cartilage repair. Products that are regarded as “minimally manipulated” and not subject to marketing approval are excluded. Products no longer on the market or with terminated clinical development are excluded. Product name, autologous or allogeneic, the most recent status of approval or clinical trials, the listed indication, cell source and delivery method of cells, and clinical trial numbers are provided where available.