Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

Study Overview
=================
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.

Official Title
-----------------
Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.

Conditions
-----------------
Perianal Fistula

Intervention / Treatment
-----------------
* Procedure: Mesenchymal Stem Cell injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stromal Vascular fraction<br>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%) | Procedure: Mesenchymal Stem Cell injection<br>* curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)<br>|
| Autologous mesenchymal stem cells<br>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%) | Procedure: Mesenchymal Stem Cell injection<br>* curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)<br>|
| Allogenic mesenchymal stem cells<br>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%) | Procedure: Mesenchymal Stem Cell injection<br>* curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with fistula healed | Complete closure of the fistula and epithelization of the external orifice | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adversus events | general adversus events | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perianal fistula, compassionate use, mesenchymal stem cells