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STATUS OF ROLE OF STEM CELL THERAPY IN PERIANAL CROHN'S FISTULA
Jai Singh
*1, Micheal Luca
1, Gabriela Olivera
2, maryam aleissa
1, Ernesto Drelichman
1, Vijay Mittal
1, Jasneet S. Bhullar
11Colon and Rectal Surgery, Ascension Providence Hospital Southfield Campus, Southfield, MI; 2University of medicine and Health sciences, Detroit, MI
Background: Perianal fistulas occur in approximately 20-30% of Crohn’s disease (CD) patients, often indicating a more aggressive disease course. These fistulas are associated with high morbidity and significantly impair the patient's quality of life. Traditional treatment options include antibiotics, immunosuppressive drugs, biologics, and surgical interventions, but they are associated with high recurrence rates, making long-term remission difficult to achieve. The complexity of perianal fistulizing CD makes it a focus of ongoing research, with new therapies like mesenchymal stem cell (MSC) therapy being explored.
Methods: A systematic literature review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched the PubMed database to identify relevant studies published between October 2014 and October 2024. The inclusion criteria were randomized controlled trials, observational studies, and clinical trials related to stem cell therapy for perianal fistulizing Crohn’s disease, written in English. Data from the selected studies were extracted and analyzed.
Results: An initial search yielded 29 articles, of which 20 met the criteria. The trials included Phase 1 (safety and feasibility), open-label (without control groups), and Phase II/III double- and single-blind, placebo-controlled RCTs. MSCs used included autologous and allogeneic adipose tissue, bone marrow-derived MSCs, and amnion MSCs. Outcomes were measured by fistula closure, drainage cessation, MRI, the Perianal Disease Activity Index, and the Crohn's Disease Activity Index.
Follow-up ranged from 24 weeks to 4 years. MSC therapy groups had significantly higher fistula healing rates, with remission rates of 50-56% compared to 0-40% in controls. Sustained remission was observed in the treatment group, with one study reporting a 51.5% remission at 24 weeks versus 35.6% in controls, increasing to 56.3% at 52 weeks versus 38.6%. Another study showed 87% fistula closure after 4 years. MSC therapies were well tolerated, with rare, non-life-threatening complications such as abscesses and post-procedure pain.
Conclusion: MSC therapy represents a promising new treatment option for refractory perianal Crohn’s disease, offering higher healing rates and fewer relapses compared to conventional therapies. The trials collectively demonstrate both the safety and efficacy of stem cell therapies, although further studies with larger patient populations and longer follow-up periods are needed to fully validate these findings.
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