Status:
RECRUITING
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Togethe...
Detailed Description
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. Togethe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04010526
Start Date
February 19 2020
End Date
October 1 2028
Last Update
October 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, France, 13354