NCT03726255

Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 24 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perianal Fistula

Interventions

Type	Name	Description
PROCEDURE	Mesenchymal Stem Cell injection	curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-01-26
• Completion: 2018-07-26
• First posted: 2018-10-31
• Last updated: 2018-11-13

Locations

1 site across 1 country: Spain