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New treatment option for Crohn Disease
Official title Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula
ClinicalTrials.gov ID: NCT06636032
What this study is testing
What is AdMSC (CellReady®)?
AdMSC (CellReady®) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for crohn disease.
Also referred to as AdMSC.
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
- Perianal fistulas are in the forefront (42 to 72, 4%) of morbid complication of Crohn's disease, affecting nearly one- third of patients and complicating abscesses in 35-48% of cases. The current treatment is based on the combination of drainage (proctologic and surgical), and biologics techniques, but the failure rate varies from 30 to 80%.
- Phase 2: a mid-size study of how well it works
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
- Patients over 18 years old,
- Patients who signed the informed consent,
- Patient affiliated to a social security system,
- Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological...
- Colonoscopy less than a year old without ulcer in the rectum,
You likely can't join if
- Refusal of the patient to participate in the study,
- Positive QuantiFERON test,
- Patient with transplanted organ,
- History of cancer in the last five years or lympho-proliferative disease,
- Persistent bacterial or viral infection,
- Patient with a contraindication to MRI,
See the full eligibility criteria
- Patients over 18 years old,
- Patients who signed the informed consent,
- Patient affiliated to a social security system,
- Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological and/or radiological criteria for more than 3 months,
- Colonoscopy less than a year old without ulcer in the rectum,
- Presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports,
- Patient treated with a combined treatment (drainage on setons + anti-TNFα) and who failed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled
- Refusal of the patient to participate in the study,
- Positive QuantiFERON test,
- Patient with transplanted organ,
- History of cancer in the last five years or lympho-proliferative disease,
- Persistent bacterial or viral infection,
- Patient with a contraindication to MRI,
- Known allergy to Gadolinium,
- Known allergy to Albumine,
- End-stage organ failure,
- Pregnant or breastfeeding women,
- Women of childbearing age without effective contraception throughout the duration of the study,
- Patient under judicial protection, under guardianship or curatorship.
- Patient previously treated with ALOFISEL®
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, 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 Toulouse, 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.