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New treatment option for Crohn Disease
Official title Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.
ClinicalTrials.gov ID: NCT04010526
What this study is testing
What is local co-administration of autologous ADIpose?
local co-administration of autologous ADIpose is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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
You likely can't join if
- 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
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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, PACA, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, PACA, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.