Using fat-derived stem cells to treat stubborn perianal fistulas in Crohn's disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.