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Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN’s Fistulas : ADICROHN II
EU CTIS ID: 2024-517794-24-00
What this study is testing
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 (W24)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 one or more refractory perianal fistula(s) assessed by clinical assessment during examination under anaesthesia (preparation treatment) and MRI
- Non-active or mildly active luminal CD defined as 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
You likely can't join if
- Presence of dominant luminal active Crohn’s disease requiring immediate therapy
- 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 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible by lipoharvest
- Any active viral infection following: HIV, HTLV I and II, VHB, VHC and Syphillis
See the full eligibility 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 one or more refractory perianal fistula(s) assessed by clinical assessment during examination under anaesthesia (preparation treatment) and MRI
- Non-active or mildly active luminal CD defined as 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.
- Affiliation to a social security scheme
- Presence of dominant luminal active Crohn’s disease requiring immediate therapy
- 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 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible by lipoharvest
- Any active viral infection following: HIV, HTLV I and II, VHB, VHC and Syphillis
- Bleeding disorders precluding surgical procedure
- Patients with known hypersensitivity to human albumin
- Participation in an another clinical trial
- Adults without legal capacity
- Patients in Health and Social Establishments
- CDAI > 220
- Persons in emergency situations
- Persons deprived of their liberty
- Non Affiliated to a social security scheme
- Absence or refusal of the informed consent
- 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 within 5 years prior to enrolment into this clinical study
- Congenital or acquired immunodeficiencies
- Contraindication to local anaesthetics or gadolinium (MRI contrast)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.