NCT04010526RecruitingPhase 2
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
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.
Source: ClinicalTrials.gov · Last updated 1 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 6 Sept 2018
- Start date
- 19 Feb 2020
- Primary completion date
- Jul 2028
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Crohn's disease
- NCT number
- NCT04010526
- EU CT number
- 2024-517794-24-00
- EudraCT number
- 2019-001948-21
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 84
- From 19 Feb 2020 to the primary completion date, Jul 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 05 | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen decex | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.