Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula (RESCeCUF)

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Completed

Conditions: Perianal Fistula

Treatments: Procedure: Mesenchymal Stem Cell injection

Study type: Observational

Funder types: Other

Identifiers

NCT03726255

EO166-18_FJD

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 24 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 3 patient groups

Stromal Vascular fraction

Description:

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%)

Treatment:

Procedure: Mesenchymal Stem Cell injection

Autologous mesenchymal stem cells

Description:

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%)

Treatment:

Procedure: Mesenchymal Stem Cell injection

Allogenic mesenchymal stem cells

Description:

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%)

Treatment:

Procedure: Mesenchymal Stem Cell injection