Crohn'sRecruiting
Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
Phase 2 · Testing local co-administration of autologous ADIpose · 1 site · Assistance Publique Hopitaux De Marseille
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing local co-administration of autologous ADIpose (a combination product). Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 4 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 84 participants are expected to take part.
- Start date: 2020-02-19.
- Main results expected around 2028-07 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- clinically evaluated (24 weeks (w))
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
| Enrollment | 84 (estimated) |
| Start date | 2020-02-19 |
| Primary completion (est.) | 2028-07 |
| First posted | 2019-07-08 |
| Last updated | 2024-10-01 |
| Official title | 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. |
| ClinicalTrials.gov ID | NCT04010526 |
Interventions
- local co-administration of autologous ADIpose (Combination Product)
local co-administration of autologous ADIpose derived stromal vascular fraction and microfat for refractory perianal CROHN's fistulas Each batch of the final product is composed of one 5 mL syringes containing 25,9 +/- 10,7 millions viable cells. Each syringe will be obstructed with a sterile stopper and packaged in an external packaging. - placebo (Other)
local co-administration of placebo The study placebo will consist of a saline solution for intralesional administration and will follow the same administration schema described for the SFV
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Des Hopitaux de Marseille | Marseille, PACA | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.