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Completed

NCT Number: NCT03726255

Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

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 .

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Key information

Conditions

Perianal Fistula

Age range

24 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Investigación Sanitario Fundación Jiménez Díaz

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal Stem Cell injection

Procedure

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

Primary outcomes

  1. Number of patients with fistula healed

    Time frame: 12 months

    Complete closure of the fistula and epithelization of the external orifice

Secondary outcomes

  1. Number of adversus events

    Time frame: 12 months

    general adversus events

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study title

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

Acronym: RESCeCUF

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2018
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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