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Stem Cell Therapy: A Compassionate Use Program in Perianal Fistula
M D Herreros1, D Garcia-Olmo1,2,3, H Guadalajara1,3,4
1Department of Surgery, University Hospital Fundación Jiménez Díaz, Madrid, Spain.
Stem Cells International
|June 14, 2019
Summary
Stem cell therapy shows promise for complex anal fistulas in a compassionate use program. This treatment is safe and effective, leading to significant healing in patients with severe, non-healing conditions.
Area of Science:
- Regenerative Medicine
- Gastroenterology
- Surgical Innovation
Background:
- Complex perianal fistulas often present treatment challenges, particularly in patients who have failed multiple prior surgical interventions.
- Compassionate use programs offer access to novel therapies for severe, non-healing diseases outside of clinical trials.
- Stem cell therapy is an emerging option for complex fistulas, leveraging the regenerative potential of various cell types.
Purpose of the Study:
- To evaluate the safety and efficacy of stem cell therapy in a compassionate use program for patients with complex perianal fistulas.
- To assess healing rates and long-term outcomes following stem cell treatment for refractory fistulas.
- To report on the types of stem cells used and their impact on treatment response.
Main Methods:
- A compassionate use program utilized stem cell therapy (stromal vascular fraction, autologous or allogeneic adipose-derived stem cells) in conjunction with surgery for complex perianal fistulas.
- Patients included had undergone multiple failed surgical treatments and did not meet criteria for clinical trials.
- Outcomes were assessed at 6-month follow-up for partial response or healing, with relapse evaluated at 1 year.
Main Results:
- The study included 45 patients (52 cases), with 42 cases of fistula-in-ano, primarily Crohn's-associated (18) and cryptoglandular (24).
- A high rate of partial response (94.2%) was observed, with 46.2% achieving complete healing within a mean of 5.5 months.
- No adverse effects related to stem cell therapy were reported, and all initially healed patients remained healed at 1-year follow-up.
Conclusions:
- Stem cell therapy is a safe and effective treatment option for complex anal fistulas, even in severe, refractory cases.
- The compassionate use program demonstrated successful healing rates, suggesting a viable therapeutic strategy.
- Further research into stem cell applications for complex perianal fistulas is warranted.
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