Using fat-derived stem cells to treat stubborn perianal fistulas in Crohn's disease patients
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.
This study is testing if injections of fat-derived stem cells can help heal stubborn perianal fistulas in people with Crohn's disease who haven't found relief with regular treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, PACA) |
| Trial ID | NCT04010526 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of local injections of autologous adipose-derived stromal vascular fraction (ADSVF) combined with microfat in treating complex perianal fistulas in patients with Crohn's disease who have not responded to standard therapies. The study aims to assess the closure of fistulas and the absence of fluid collections through clinical evaluations and MRI at 24 weeks post-treatment. Participants will receive either the combined treatment or a placebo to determine the efficacy of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Crohn's disease and complex perianal fistulas that have not responded to conventional treatments.
Not a fit: Patients with active luminal Crohn's disease requiring immediate therapy or those who have not previously received specific treatment for perianal fistulas may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for patients suffering from refractory perianal fistulas associated with Crohn's disease.
How similar studies have performed: While the use of ADSVF has shown promise in other clinical fields, this specific approach for treating perianal fistulas in Crohn's disease is still being evaluated for its therapeutic potential.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille, PACA
- Assistance Publique Des Hopitaux de Marseille — Marseille, Paca, France (Recruiting)
Study contacts
- Study coordinator: Jean Charles Grimaud, Md
- Email: Jean-charles.GRIMAUD@ap-hm.fr
- Phone: +33491368739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.