NCT04010526 Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
| NCT ID | NCT04010526 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2020-02-19 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2020-02-19 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Presence of dominant luminal active Crohn's disease requiring immediate therapy * CDAI \> 220 * Patient naïve to specific treatment for perianal fistulising Crohn's disease * Presence of an abscess or collections \> 2 cm, unless resolved in the preparation procedure * 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 * Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease * 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 * Contraindication to the anaesthetic or surgical procedure * BMI \< 18 to insure adequate abdominal or other subcutaneous adipose tissue accessible by lipoharvest * Any active viral infection follows: HIV, HTLV I et II, VHB, VHC and Syphillis
Contact & Investigator
EMILIE GARRIDO PRADALIE
STUDY DIRECTOR
APHM
Frequently Asked Questions
Who can join the NCT04010526 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04010526 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04010526 currently recruiting?
Yes, NCT04010526 is actively recruiting participants. Contact the research team at Jean-charles.GRIMAUD@ap-hm.fr for enrollment information.
Where is the NCT04010526 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT04010526 clinical trial?
NCT04010526 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is EMILIE GARRIDO PRADALIE at APHM. The trial plans to enroll 84 participants.