Hurdles to overcome for mesenchymal stem cell translation from bench to bedside

Table 1 Mesenchymal stem cell-based products that have received market approval from major regulatory agencies

Product name	Developer company	Cell type	Indication	Regulatory body	Country	Year	Ref.
Ryoncil™ (remestemcel-L)	Mesoblast	Allo-BM-MSC	Pediatric SR-aGvHD	United States FDA	United States	2024	[20]
Cupistem®	Anterogen	Auto-AD-MSCs	Perianal Crohn’s fistula	MFDS	South Korea	2012	[19]
Cartistem®	Medipost	UC-MSC	Knee OA	MFDS	South Korea	2012	[19]
Temcell HS®	JCR Pharmaceuticals	Allo-BM-MSC	SR-aGvHD	PMDA	Japan	2015	[19,20]
Amimestrocel (conditional approval)	Platinum Life Excellence Biotech	UC-MSC	SR-aGvHD with gastrointestinal tract involvement in 14 years of age and older	NMPA	China	2025	[21]
Cellgram AMI	Pharmicell	Auto-BM-MSC	AMI	MFDS	South Korea	2011	[19]
NeuroNata-R	Corestem	Auto-BM-MSC	ALS	MFDS	South Korea	2014	[19]
Stempeucel	Stempeutics Research	Allo-BM-MSC	CLI	DCGI	India	2016	[19]
MesestroCell	Cell Tech Pharmed	Auto-BM-MSC	OA	IFDA	Iran	2018	[19]
Stemirac	Nipro Corp	Auto-BM-MSC	SCI	PMDA	Japan	2018	[19]

Allo-BM-MSC: Allogeneic bone marrow-derived mesenchymal stem cells; SR-aGvHD: Steroid-refractory acute graft vs host disease; FDA: Food and Drug Administration; Auto-AD-MSCs: Autologous adipose derived mesenchymal stem cell; MFDS: Ministry of Food and Drug Safety; UC-MSC: Umbilical cord-derived mesenchymal stem cell; OA: Osteoarthritis; PMDA: Pharmaceuticals and Medical Devices Agency; NMPA: National Medical Products Administration; Auto-BM-MSC: Autologous bone marrow-derived mesenchymal stem cell; AMI: Acute myocardial infarction; ALS: Amyotrophic lateral sclerosis; CLI: Critical limb ischemia; DCGI: Drugs Controller General of India; IFDA: Iran Food and Drug Administration; SCI: Spinal cord injury.