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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03726255

Acronym

RESCeCUF

Enrollment

Registered

2018-10-31

Start date

2014-04-01

Completion date

2018-07-26

Last updated

2018-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perianal Fistula

Keywords

Perianal fistula, compassionate use, mesenchymal stem cells

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.

Interventions

PROCEDUREMesenchymal Stem Cell injection

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with fistula healed	12 months	Complete closure of the fistula and epithelization of the external orifice

Secondary

Measure	Time frame	Description
Number of adversus events	12 months	general adversus events

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026