Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

Perianal Fistula Clinical Trial

— RESCeCUF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726255
• Other study ID #: EO166-18_FJD
• Status: Completed
• Start date: April 1, 2014
• Est. completion date: July 26, 2018

Study information

• Verified date: October 2018
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 26, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Perianal Fistula
• Rectal Fistula

Intervention

Procedure:
• Mesenchymal Stem Cell injection
curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Locations

Country	Name	City	State
Spain	Instituto Investigación Sanitario Fundación Jiménez Díaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with fistula healed	Complete closure of the fistula and epithelization of the external orifice	12 months
Secondary	Number of adversus events	general adversus events	12 months