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Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula (RESCeCUF)

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ClinicalTrials.gov Identifier: NCT03726255
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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 .

Condition or disease Intervention/treatment
Perianal Fistula Procedure: Mesenchymal Stem Cell injection

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.


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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : July 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort Intervention/treatment
Stromal Vascular fraction
31 patients were treated with one injection of Stromal Vascular Fraction from adipose tissue obtained by liposuction. Procedure: curettage, closure of the internal opening (IO) and SVF injection in IO (50%) and fistula tract (50%)
Procedure: Mesenchymal Stem Cell injection
curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Autologous mesenchymal stem cells
9 patients were treated with one injection of autologous mesenchymal stem cells from adipose tissue. Procedure: curettage, closure of the internal opening (IO) and autologous cell injection in IO (50%) and fistula tract (50%)
Procedure: Mesenchymal Stem Cell injection
curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)

Allogenic mesenchymal stem cells
12 patients were treated with one injection of allogenic mesenchymal stem cells of healthy donors: Procedure: curettage, closure of the internal opening (IO) and allogenic cell injection in IO (50%) and fistula tract (50%)
Procedure: Mesenchymal Stem Cell injection
curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)




Primary Outcome Measures :
  1. Number of patients with fistula healed [ Time Frame: 12 months ]
    Complete closure of the fistula and epithelization of the external orifice


Secondary Outcome Measures :
  1. Number of adversus events [ Time Frame: 12 months ]
    general adversus events



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Ages Eligible for Study:   24 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We present an observational study, including 52 cases (53% male and 47% female) treated by a compassionate use ASC program. The mean age was 45 years and ranged from 24 to 69 years. There were 42 perianal fistulas, 7 rectovaginal fistulas, 1 urethrorectal fistula, 1 sacral fistula and 1 hidradenitis suppurativa. All the cases had previous failed surgeries. Thirteen of fifty-two (25%) of the cases presented fecal incontinence at the moment of enrollment. 5/52 (9,6%) of the cases presented anal stenosis and 11/52 (21%) had a scaring anus.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726255


Locations
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Spain
Instituto Investigación Sanitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Investigators
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Principal Investigator: Damian Garcia-Olmo, Prof. Instituto de Investigación Sanitaria Fundación Jiménez Díaz

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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT03726255     History of Changes
Other Study ID Numbers: EO166-18_FJD
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
Perianal fistula
compassionate use
mesenchymal stem cells

Additional relevant MeSH terms:
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Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases