Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-01

Study Completion Date

2018-07-26

Brief Summary

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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 .

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Detailed Description

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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.

Conditions

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Perianal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Stromal Vascular fraction

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%)

Mesenchymal Stem Cell injection

Intervention Type PROCEDURE

curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Autologous mesenchymal stem cells

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%)

Mesenchymal Stem Cell injection

Intervention Type PROCEDURE

curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Allogenic mesenchymal stem cells

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%)

Mesenchymal Stem Cell injection

Intervention Type PROCEDURE

curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Interventions

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Mesenchymal Stem Cell injection

curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Intervention Type PROCEDURE

Eligibility Criteria

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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