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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

Tracking Information
First Submitted Date October 26, 2018
First Posted Date October 31, 2018
Last Update Posted Date November 12, 2018
Actual Study Start Date April 1, 2014
Actual Primary Completion Date January 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2018)
Number of patients with fistula healed [ Time Frame: 12 months ]
Complete closure of the fistula and epithelization of the external orifice
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03726255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 29, 2018)
Number of adversus events [ Time Frame: 12 months ]
general adversus events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula
Official Title Retrospective Evaluation of Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Perianal Fistula
Intervention Procedure: Mesenchymal Stem Cell injection
curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)
Study Groups/Cohorts
  • 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%)
    Intervention: Procedure: Mesenchymal Stem Cell injection
  • 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%)
    Intervention: Procedure: Mesenchymal Stem Cell injection
  • 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%)
    Intervention: Procedure: Mesenchymal Stem Cell injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 29, 2018)
52
Original Actual Enrollment Same as current
Actual Study Completion Date July 26, 2018
Actual Primary Completion Date January 26, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03726255
Other Study ID Numbers EO166-18_FJD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators Not Provided
Investigators
Principal Investigator: Damian Garcia-Olmo, Prof. Instituto de Investigación Sanitaria Fundación Jiménez Díaz
PRS Account Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Verification Date October 2018