From mesenchymal stem cells to myoblast cell sheets: A next-generation regenerative concept for fistulizing Crohn’s disease

Table 1 Summary of key clinical studies evaluating mesenchymal stem cell therapy in Crohn’s disease

Ref.	Country	n (control vs MSC)	Autologous/allogeneic	Cell type/product	Follow-up	Main outcomes
Molendijk et al[48], 2015	Netherlands	6 vs 15	Allogeneic	BM-MSC	24 weeks	Fistula healing 40% vs 0%; good safety
Panés et al[42], 2016	Europe/Israel	107 vs 105	Allogeneic	AD-MSC (Cx601, darvadstrocel)	24 weeks	Combined remission 50% vs 34%; similar safety
Panés et al[6], 2018	Europe/Israel	103 vs 102	Allogeneic	AD-MSC (Cx601)	52 weeks	Sustained remission 56% vs 36%
Zhou et al[49], 2020	China	11 vs 11	Autologous	AD-MSC	52 weeks	Healing 63.6%; CDAI & PDAI improved; safe
Garcia-Olmo et al[50], 2022	Europe/Israel	15 vs 25	Allogeneic	AD-MSC (Cx601)	104 weeks	Sustained closure approximately 65%; no long-term safety issues
Lightner et al[51], 2023	United States	2-4 vs 4-15	Allogeneic	BM-MSC/Remestemcel-L	6 weeks to 3 months	Fistula healing; CDAI & CRP improvement; acceptable safety
Lindsay et al[52], 2017	United Kingdom	9 vs 13	Autologous	HSC	48 weeks	CDAI, SES-CD, IBDQ, MARIA, PRO2 improved; reversible AEs

MSC: Mesenchymal stem cells; BM-MSC: Bone marrow-derived mesenchymal stem cells; AD-MSC: Adipose-derived mesenchymal stem cells; CDAI: Crohn’s Disease Activity Index; PDAI: Perianal Disease Activity Index; CRP: C-reactive protein; HSC: Hematopoietic stem cell; SES-CD: Simple Endoscopic Score for Crohn’s Disease; IBDQ: Inflammatory Bowel Disease Questionnaire; AEs: Adverse events.