Actively Recruiting
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-10-01
84
Participants Needed
1
Research Sites
449 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosed Crohn's Disease at least 6 months ago according to clinical or diagnostic criteria
- Presence of refractory complex perianal fistulas confirmed by examination and MRI
- Non-active or mildly active Crohn's Disease (CDAI ≤ 220)
- Male or female patients aged 18 years or older
- Good overall health based on medical history and physical exam
- For women of childbearing age, negative pregnancy test and use of birth control; men must also use birth control
You will not qualify if you...
- Active luminal Crohn's Disease requiring immediate treatment
- CDAI score above 220
- No prior treatment for perianal fistulising Crohn's disease
- Abscess or fluid collection larger than 2 cm unless resolved before treatment
- Rectal or anal narrowing limiting surgery
- Current or recent steroid treatment within 4 weeks
- History of cancer or fistula-related cancer
- Severe or uncontrolled infections or other serious diseases
- Immune system deficiencies
- Allergy to local anesthetics or MRI contrast agents
- Contraindications to MRI (e.g., pacemakers, hip replacements, severe claustrophobia)
- Pregnant or breastfeeding women
- Contraindications to anesthesia or surgery
- Body mass index below 18
- Active viral infections such as HIV, HTLV, hepatitis B or C, or syphilis
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Trial Site Locations
Total: 1 location
1
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, France, 13354
Actively Recruiting
Research Team
J
JEAN CHARLES GRIMAUD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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