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Research library

Clinical research overview

This library brings together peer-reviewed studies on Mesenchymal Stem Cells (MSCs) across a wide range of medical indications. Each study contributes to a deeper understanding of how MSCs support repair, regeneration, and immune balance in the body.
Crohn's disease Aging frailty Osteoarthritis
Acute respiratory disease syndrome Graft versus host disease (GvHD) Multiple sclerosis Liver cirrhosis Diabetes type II Diabetes type I Chronic low back pain Chronic obstructive pulmonary disease (COPD) Alzheimer's disease Rheumatoid arthritis

Crohn's disease

Clinical research is investigating the potential of mesenchymal stem cells (MSCs) in Crohn's disease. Studies focus on safety, feasibility, and possible immunomodulatory properties, contributing to the evolving evidence base in Inflammatory Bowel Disease (IBD). Crohn's disease is a chronic form of IBD that causes ongoing inflammation of the digestive tract, most often in the small intestine and colon. Common symptoms include abdominal pain, diarrhea, and weight loss. Conventional therapies may reduce inflammation but do not provide a cure, and many patients continue to experience relapses. Ongoing MSC clinical trials aim to assess whether their immune-regulating and tissue-repairing properties could support disease management. While research remains at an exploratory stage, these studies are expanding scientific understanding of how cell-based approaches might contribute to future IBD treatment strategies.

Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial

Jian Zhang, et al.
Stem cell therapy has been applied to treat a variety of autoimmune diseases, including Crohn's disease (CD), but few studies have examined the use of umbilical cord mesenchymal stem cells (UC-MSCs). This trial sought to investigate the efficacy and safety of UC-MSCs for the treatment of CD.
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Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial

Julián Panés, et al.
Complex perianal fistulas in Crohn's disease are challenging to treat. Allogeneic, expanded, adipose-derived stem cells (Cx601) are a promising new therapeutic approach. We aimed to assess the safety and efficacy of Cx601 for treatment-refractory complex perianal fistulas in patients with Crohn's disease.
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Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial

Damián Garcia-Olmo, et al.
Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy outcomes from the clinical trial known as 'Adipose derived mesenchymal stem cells for induction of remission in perianal fistulizing Crohn's disease,' or ADMIRE-CD (NCT01541579), from up to 52 weeks posttreatment were previously reported. Here, the outcomes from an extended 104-week follow-up are reported.
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The safety of autologous and metabolically fit bone marrow mesenchymal stromal cells in medically refractory Crohn's disease - a phase 1 trial with three doses

T Dhere, et al.
All patients tolerated the mesenchymal stromal cell infusion well and no dose limiting toxicity was seen. Seven patients had serious adverse events of which five were hospitalisations for Crohn's disease flare. Two of these serious adverse events were possibly related to the mesenchymal stromal cells infusion. Five subjects showed clinical response 2 weeks after the infusion. Mesenchymal stromal cell phenotype, cytokine responsiveness, and peripheral blood mononuclear cell proliferation blockade were not different among the patients.
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A phase 2 study of allogeneic mesenchymal stromal cells for luminal Crohn's disease refractory to biologic therapy

Geoffrey M Forbes, et al.
In the study, 15 patients showed a significant reduction in mean CDAI score from 370 to 203 at day 42 after MSC infusion, with scores decreasing after each infusion. 80% of patients had a clinical response, with 53% achieving clinical remission. 7 patients had endoscopic improvement, and one patient experienced a serious adverse event (2 dysplasia-associated lesions), which was unlikely caused by MSCs.
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Mesenchymal Stem Cell Injection in Crohn's Disease Strictures: A Phase I-II Clinical Study

Sophie Vieujean, et al.
MSC injections were well tolerated but four hospitalisations for occlusion were reported. At W12, five patients presented a complete or partial resolution of the stricture [two complete and three partial]. Seven patients were re-evaluated at W48 [one dilated, one operated, and one lost to follow-up] and four patients had a complete resolution. The evolution of clinical scores between W0, W12, and W48 was not statistically significant. MSCs injection in CD stricture was well tolerated and may offer a benefit.
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A Phase IB/IIA Study of Allogeneic, Bone Marrow-derived, Mesenchymal Stem Cells for the Treatment of Refractory Ileal-anal Anastomosis and Peripouch Fistulas in the Setting of Crohn's Disease of the Pouch

Amy L Lightner, et al.
At 6 months, 31% of the treatment group and 20% of the control had complete clinical and radiographic healing. When stratifying the treatment group into perianal [n = 7] and ano-vaginal [n = 8] fistulas, 6-month healing in the treatment groups was 57% and 0%, respectively. The perianal Crohn's disease activity index [PCDAI], Wexner incontinence score, and van Assche score all significantly decreased in treatment patients at 6 months; only the PCDAI decreased in the control group. One marrow-derived, allogeneic MSCs offer a safe and effective alternative treatment approach for peripouch fistulas in the setting of a Crohn's like phenotype of the pouch.
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Long-term Evaluation of Allogeneic Bone Marrow-derived Mesenchymal Stromal Cell Therapy for Crohn's Disease Perianal Fistulas

Marieke C Barnhoorn, et al.
Thirteen out of 15 patients [87%] treated with bmMSCs were available for long-term follow-up. Two non-MSC related malignancies were observed. No serious adverse events thought to be related to bmMSC therapy were found. In cohort 2 [n = 4], all fistulas were closed 4 years after bmMSC therapy. In cohort 1 [n = 4] 63%, and in cohort 3 [n = 5] 43%, of the fistulas were closed, respectively. In none of the patients anti-HLA antibodies could be detected 24 weeks and 4 years after therapy.
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