Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

NCT03726255 | Completed

• 1 other identifier: EO166-18_FJD
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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 .

Conditions

Perianal Fistula

Keywords

Perianal fistula; compassionate use; mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• Number of patients with fistula healed

  Complete closure of the fistula and epithelization of the external orifice

  12 months

Secondary Outcomes (1)

• Number of adversus events

  12 months

Study Arms (3)

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%)

Procedure: Mesenchymal Stem Cell injection

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%)

Procedure: Mesenchymal Stem Cell injection

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%)

Procedure: Mesenchymal Stem Cell injection

Interventions

Mesenchymal Stem Cell injection PROCEDURE

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

Allogenic mesenchymal stem cells; Autologous mesenchymal stem cells; Stromal Vascular fraction

Eligibility Criteria

• Age: 24 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We present an observational study, including 52 cases (53% male and 47% female) treated by a compassionate use ASC program. The mean age was 45 years and ranged from 24 to 69 years. There were 42 perianal fistulas, 7 rectovaginal fistulas, 1 urethrorectal fistula, 1 sacral fistula and 1 hidradenitis suppurativa. All the cases had previous failed surgeries. Thirteen of fifty-two (25%) of the cases presented fecal incontinence at the moment of enrollment. 5/52 (9,6%) of the cases presented anal stenosis and 11/52 (21%) had a scaring anus.

You may qualify if:

• 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

You may not qualify if:

• not signature informed consent

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Instituto Investigación Sanitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Study Officials

• Damian Garcia-Olmo, Prof.

  Instituto de Investigación Sanitaria Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 31, 2018
• Study Start: April 1, 2014
• Primary Completion: January 26, 2018
• Study Completion: July 26, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)