Abstract
Aim To report our experience in a compassionate use program for complex perianal fistula. Methods Under controlled circumstances and approved by European and Spanish laws, a compassionate use program allows the use of stem cell therapy for patients with nonhealing diseases, mostly complex fistula-in-ano, who do not meet criteria to be included in a clinical trial. Candidates had previously undergone multiple surgical interventions that had failed. The intervention consisted of surgery (with closure of the internal opening or a surgical flap performance), followed by stem cell injection. Three types of cells were used for implant: stromal vascular fraction, autologous expanded adipose-derived, or allogenic adipose-derived stem cells. Healing was evaluated at 6th month follow-up. Outcome was classified as partial response or healing. Relapse was evaluated 1 year later. Maximum follow-up period was 48 months. Results 45 patients (24 male) were included; the mean age was 45 years, which ranged from 24 to 69 years. Since some of them received repeated doses, 52 cases were considered (42 fistula-in-ano, 7 rectovaginal fistulas, 1 urethrorectal fistula, 1 sacral fistula, and 1 hidradenitis suppurativa). Regarding fistula-in-ano, there were 18 Crohn's-associated and 24 cryptoglandular. 49 cases (94.2%) showed partial response starting 6.5 weeks of follow-up. 24 cases (46.2%) healed in a mean time of 5.5 months. A year later, all patients cured remained healed. No adverse effects related to stem cell therapy were reported. Conclusion Stem cells are safe and useful for treating anal fistulae. Healing can be achieved in severe cases.
Highlights
The incidence of fistula-in-ano ranges from 1.1 to 2.2 per 10,000 population per year [1, 2]
adipose-derived stem cells (ASCs) are purified from adipose tissue [14, 15], which can be readily and safely obtained by liposuction [11]
The aim of this paper is to report our experience in a compassionate use program since April 2014 to nowadays in patients with at least 6 months of follow-up
Summary
The incidence of fistula-in-ano ranges from 1.1 to 2.2 per 10,000 population per year [1, 2]. Application of autologous adipose-derived stem cells (ASCs) represents a novel approach for enhancing regeneration and/or repair of damaged tissues [6, 7] in an environment unfavorable for wound healing [8,9,10,11]. ASCs are purified from adipose tissue [14, 15], which can be readily and safely obtained by liposuction [11]. The process yields 100 times more stem cells than bone marrow aspirates [16] and the process is considered safe [17]. A previous proof-of-concept phase I clinical trial in fistulizing Crohn’s disease [18] and a phase II and two phase III clinical trial (CT) in fistulas of cryptoglandular origin and fistulas associated to Crohn’s disease [19,20,21] found ASCs to be safe and effective
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