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Taking people in FrancePhase 2

Tests fat-derived cell injection for hard-to-heal perianal Crohn's fistulas

Tests injected fat-derived cells with microfat against placebo in adults with Crohn's fistulas.

Key facts

Who runs it
Assistance Publique Hopitaux De Marseille
Where
Marseille, Montpellier Cedex 05, Nantes, Nîmes, and Rouen decex, FranceSee the 5 sites
Registry title
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
Status
Recruiting
Phase
Phase 2
People taking part
84 people, planned
Started
19 Feb 2020
Expected to end
Oct 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • local co-administration of autologous ADIpose
  • placebo
Record updated
1 October 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who have complex perianal fistulas that did not respond to usual medical and surgical treatment.

Age
18 years or older
Sex
Women and men can join.
Disease stage
Crohn's disease diagnosed at least 6 months ago, with complex perianal fistulas that did not respond to treatment. The bowel disease must be inactive or mildly active (CDAI 220 or lower).
Earlier treatment
People must have had specific treatment for perianal fistulising Crohn's disease before. They cannot join if they are taking steroids or took them in the last 4 weeks.

Main reasons for not taking part

  • Active Crohn's bowel disease that needs treatment right away, or CDAI above 220
  • An abscess or collection larger than 2 cm (0.8 in), unless it was cleared before the trial
  • Past or current cancer of any kind
  • Pregnant or breastfeeding women
  • Active viral infection: HIV, HTLV I and II, VHB, VHC, or syphilis

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Signed informed consent
  • Patients with Crohn's Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria
  • Presence of refractory complex perianal fistulas assessed by clinical assessment during examination under anaesthesia (preparation treatment) and MRI
  • Non-active or mildly active luminal CD defined by a CDAI ≤ 220
  • Patients of either sex aged 18 years or older
  • Good general state of health according to clinical history and a physical examination
  • For women of a childbearing age, they must have negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both men and women should use appropriate birth control methods defined by the investigator

Who cannot take part

  • Rectal and/or anal stenosis if this means a limitation for any surgical procedure
  • Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks
  • Malignant tumour or patients with a prior history of any malignant tumour, including any type of fistula carcinoma
  • Contraindication to the anaesthetic or surgical procedure
  • Presence of dominant luminal active Crohn's disease requiring immediate therapy
  • Patient naïve to specific treatment for perianal fistulising Crohn's disease
  • Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease
  • Any active viral infection follows: HIV, HTLV I et II, VHB, VHC and Syphillis
  • CDAI > 220
  • Presence of an abscess or collections > 2 cm, unless resolved in the preparation procedure
  • Congenital or acquired immunodeficiencies
  • Contraindication to local anaesthetics or gadolinium (MRI contrast)
  • Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia)
  • Pregnant or breastfeeding women
  • BMI < 18 to insure adequate abdominal or other subcutaneous adipose tissue accessible by lipoharvest

Where in France

  • Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
  • CHU de MontpellierMontpellier Cedex 05, FranceTaking people
  • Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
  • Centre Hospitalier Universitaire de NîmesNîmes, FranceTaking people
  • CHU de RouenRouen decex, FranceTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • treatmentTreatment being tested

    CD patients with complex refractory perianal fistula refractory to conventional medical and surgical therapy referred to the gastroenterology departments of the 3 centers in charge of treatment local co-administration of autologous ADIpose will be performed

    Treatment: local co-administration of autologous ADIpose

  • placeboPlacebo, for comparison

    CD patients with complex refractory perianal fistula refractory to conventional medical and surgical therapy referred to the gastroenterology departments of the 3 centers in charge of treatment local co-administration of placebo will be performed

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Double-blind Randomised Placebo Controlled Study Evaluating Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
Plain-language title
Tests fat-derived cell injection for hard-to-heal perianal Crohn's fistulasGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 October 2024