Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Perianal Fistula
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Number of patients with fistula healed
- Status
- Completed
- Last Updated
- 7 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Number of patients with fistula healed
Time Frame: 12 months
Complete closure of the fistula and epithelization of the external orifice
Secondary Outcomes
- Number of adversus events(12 months)