Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

Completed

• Conditions: Perianal Fistula
• Interventions: Procedure: Mesenchymal Stem Cell injection

• Registration Number: NCT03726255
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary

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 .

Detailed Description

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.

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2018-01-26
• Study Completion: 2018-07-26
• Status Verified: 2018-10
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• patients with complex perianal fistula
• patients who didn't meet criteria of the clinical trial (CT) in development
• foreign patients, who were not allowed to be included in the CT
• patients included in some CT control arms
• failure treatment in patients included in a CT treatment arm as a retreatment

Exclusion Criteria

• not signature informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stromal Vascular fraction	Mesenchymal Stem Cell injection	31 patients were treated with one injection of Stromal Vascular Fraction from adipose tissue obtained by liposuction. Procedure: curettage, closure of the internal opening (IO) and SVF injection in IO (50%) and fistula tract (50%)
Autologous mesenchymal stem cells	Mesenchymal Stem Cell injection	9 patients were treated with one injection of autologous mesenchymal stem cells from adipose tissue. Procedure: curettage, closure of the internal opening (IO) and autologous cell injection in IO (50%) and fistula tract (50%)
Allogenic mesenchymal stem cells	Mesenchymal Stem Cell injection	12 patients were treated with one injection of allogenic mesenchymal stem cells of healthy donors: Procedure: curettage, closure of the internal opening (IO) and allogenic cell injection in IO (50%) and fistula tract (50%)

Primary Outcome Measures

Name	Time	Method
Number of patients with fistula healed	12 months	Complete closure of the fistula and epithelization of the external orifice

Secondary Outcome Measures

Name	Time	Method
Number of adversus events	12 months	general adversus events

Trial Locations

Locations (1)

Instituto Investigación Sanitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain