The Achievements and Challenges of Mesenchymal Stem Cell-Based Therapy in Inflammatory Bowel Disease and Its Associated Colorectal Cancer

Table 2

Clinical trials of MSC-based therapy in IBD.

MSC source/type	Type of trial	Route of administration	Condition	Outcome	Reference
Adipose/allogeneic	Phase 3 randomized, double-blind controlled trial	Intralesional injection	Perianal fistulas in CD	(i) Significant clinical remission; (ii) Improved PDAI	[112]
Bone marrow/allogeneic	Efficacy and safety study	Intravenous injection	UC	(i) Powerful immunomodulatory effects; (ii) Reduced activity of autoimmune inflammation and stimulated reparative process in the intestinal mucosa, hence increasing the duration of remission, reducing the risk of recurrence of disease, and reducing the frequency of hospitalizations	[120]
Bone marrow/allogeneic	Double-blind, placebocontrolled study	Intralesional injection	Perianal fistulas in CD	(i) Promoted healing of perianal fistulas; (ii) Improved PDAI	[111]
Umbilical cord	Non-randomized safety and therapeutic efficacy study	Intravenous infusion	Moderate to severe UC	(i) 30/36 patients treated with MSC showed good response; (ii) Diffuse and deep ulcer formation and severe inflammatory mucosa were improved markedly; (iii) -During the follow-up, the median Mayo score and histology score were decreased while IBDQ scores significantly improved	[121]
Bone marrow/allogeneic	Phase 2, open-label, multicenter study	Intravenous infusions	Luminal CD	(i) Reduced CDAI and CDEIS scores; (ii) Significant clinical remission	[108]
Adipose/autologous	Long-term sustained response assessment	Submucosal fistula injection	Fistulas in CD	(i) High proportion of complete fistula closure; (ii) Sustained efficacy and safety	[102]
Adipose/autologous	Prospective phase I clinical trial	Fistula inoculation	Fistula in CD	(i) 6/8 fistulas completely healed. The other 2 with incomplete closure of the external opening	[114]
Bone marrow/autologous	Phase I safety and feasibility study	Intravenous injection	Refractory CD	(i) Significantly reduced CDAI and CDEIS scores; (ii) While 3/10 showed clinical response, another 3/10 required surgery due to disease worsening	[105]
Adipose/allogeneic	Multicenter phase I/IIa clinical trial	Intralesionally injection	Perianal fistula in CD	(i) 56.3% of the patients achieved complete closure of the treated fistula; (ii) MRI score of severity showed marked reduction at week 24	[113]
Adipose/allogeneic	Phase I-IIa clinical trial	Intralesional injection	Crohn’s-related rectovaginal fistula	60% of patients achieved a complete healing	[115]

A summary of clinical trials obtained from MSC-based therapy in IBD. In each observation, route of administration, type of IBD, and final outcome of the therapy are outlined.