Perianal Fistula Clinical Trial
Official title:
Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.
This observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal fistula according to the Spanish national Compassionate-use law .
Under controlled circumstances, and approved by European and Spanish laws, a
Compassionate-use Program allows the use of stem-cell therapy for patients with non-healing
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 cells 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.
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