2023 Next Steps, page-154

Reg, what do you make of this? Is it the same trial or a different one?

https://pubmed.ncbi.nlm.nih.gov/36602511/

Design: Phase IB/IIA randomized control trial.

Settings: Tertiary inflammatory bowel disease referral center.

Patients: Adult Crohn's patients with perianal fistulizing disease.

Intervention: 75 million mesenchymal stem cells were administered with a 22G needle by direct injection after curettage and primary closure of the fistula tract. A repeat injection of 75 million mesenchymal stem cells at 3 months was given if complete clinical and radiographic healing were not achieved.

Main outcomes measures: Adverse and serious adverse events at post procedure day 1, week 2, week 6, month 3, month 6 and month 12. Clinical healing, radiographic healing per magnetic resonance imaging, and patient reported outcomes at the same time points.

Results: A total of 23 patients were enrolled and treated; 18 were treatment and 5 were control. There were no adverse or serious adverse events reported related to mesenchymal stem cells therapy. At six months, 83% of the treatment group and 40% of the control had complete clinical and radiographic healing. The perianal Crohn's disease activity index, Wexner incontinence score, and VanAssche score had all significantly decreased in treatment patients at six months; none significantly decreased in the control group.

Limitations: Single institution and single blinded.

Conclusions: Bone marrow derived mesenchymal stem cells offer a safe and effective alternative treatment approach for severe perianal fistulizing Crohn's disease. See Video Abstract at http://links.lww.com/DCR/C128.