Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula
Phase 1 / Phase 2 · Testing AdMSC (CellReady®) · 1 site · University Hospital, Toulouse
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing AdMSC (CellReady®) (a drug) as a possible treatment. Condition(s) listed: Crohn Disease.
It is open-label: participants know what they are receiving.
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:
- Patients over 18 years old,
- Patients who signed the informed consent,
- Patient affiliated to a social security system,
Plus 4 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 9 participants are expected to take part.
- Start date: 2025-03-12.
- Main results expected around 2027-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- adverse events of grade ≥ 2 at 6 months (6 months after injection)
In the researchers’ words
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%.
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 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | University Hospital, Toulouse |
| Enrollment | 9 (estimated) |
| Start date | 2025-03-12 |
| Primary completion (est.) | 2027-09 |
| First posted | 2024-10-10 |
| Last updated | 2025-12-24 |
| Official title | Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula:a Phase I/II Clinical Study |
| ClinicalTrials.gov ID | NCT06636032 |
Interventions
- AdMSC (CellReady®) (Drug)
At day 0, patients will have AdMSC injections. Patients will be followed-up for 6 months
Full eligibility criteria (from the record)
Inclusion 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 Exclusion Criteria: * 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®
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Toulouse Hospital | Toulouse | 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.