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

Evenbratt, H.; Andreasson, L.; Bicknell, V.; Brittberg, M.; Mobini, R.; Simonsson, S.

doi:10.1186/s13619-021-00104-5

Cell Regeneration

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Invossa / TissueGene-C	Allogeneic	Phase III underway in the US, withdrawn in KR	Knee Osteoarthritis	Juvenile chondrocytes and transduced cells expressing TGF-B1	Intraarticular Injection	US Phase III NCT03203330	(Clinicaltrials.gov,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MACI	Autologous	Approved in US 2016, EU in 2013, withdrawn 2018	Articular Cartilage Defect	chondrocytes from patient joint	Cell-seeded collagen membrane secured with fibrin glue during mini-arthrotomy	US Phase III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)

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.

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