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Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.

Study acronym: ADICROHN2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 2022 to Jul 2028 · Completion date: Oct 2023 to Oct 2028 · Start date changed from estimate of Mar 2020 to Feb 19, 2020 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Jul 2022 to Jul 2028
    • Completion date: Oct 2023 to Oct 2028
    • Start date changed from estimate of Mar 2020 to Feb 19, 2020
    • Site details revised
  2. Start date: Jan 2020 to Mar 2020v3
  3. Primary completion date: Jul 2021 to Jul 2022 Start date: Jul 2019 to Jan 2020 · Completion date: Oct 2021 to Oct 2023v2 Show 2 more changesShow less
    • Start date: Jul 2019 to Jan 2020
    • Completion date: Oct 2021 to Oct 2023
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Autologous ADSVF constitutes an innovative therapeutic strategy that concentrates various types of regenerative stem cells and paracrine factors able to promote angiogenesis and tissue repair. Together with the ease of collection from a minimally manipulated lipoaspirate, the unique properties of ADSVF offer new opportunities for fistulas' healing in patients with CD. The use of ADSVF is currently developed in many clinical fields based on safety and efficacy data. Our ADICROHN pilot study evaluating safety and tolerance of local administration of autologous ADSVF with microfat in CD patients with complex perianal fistula refractory to conventional medical and surgical therapy showed that this novel therapeutic approach appears feasible and safe. However the therapeutic potential of local this combined treatment in healing refractory perianal Crohn's fistulas still remains to be demonstrated. The main objective of this study is to assess the efficacy of local injection of autologous ADSVF and microfat versus placebo for the treatment of complex refractory perianal Crohn's fistulas at week 24. The efficacy will be assessed on clinical assessment of closure of all the external openings that were drained at baseline, and MRI confirmation of absence of collections \> 2 cm of the treated perianal fistulas at week 24.
Trial Details
NCT Number NCT04010526
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Crohn Disease
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov