Clinical Trial to Evaluate if the Laparoscopic Administration of Cells Derived From the Fatty Tis… (NCT05521672) | Clinical Trial Compass
TerminatedPhase 1/2
Clinical Trial to Evaluate if the Laparoscopic Administration of Cells Derived From the Fatty Tissue Can Improve the Inflammatory Stenosis in Patient With Crohn's Disease
Stopped: low recruitment
Spain2 participantsStarted 2022-10-24
Plain-language summary
A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of laparoscopic administration of adipose derived allogenic mesenchymals stem cells (adMSC), for the treatment of patients with a single inflammatory stenosis in the context of Crohn's disease.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who agree to participate and agree to give their written consent.
. Patients older than 18 years and younger than 75 years
. With Crohn's disease diagnosed at least 6 months before that meet clinical, endoscopic, histological and/or radiological criteria.
. Presence of a single inflammatory stenotic lesion in the small intestine or ileocolic area with a maximum length of 5 cm, demonstrated by magnetic resonance enterography, which produces episodes of intestinal occlusion/subocclusion. Other inflammatory lesions are admittedly present, but only one should be identified as the obvious cause of the occlusion/subocclusion.
. Patients treated with at least one biological drug and with inadequate response to maintenance doses and before intensification (either dose, interval or change/addition of another drug):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of complications
Timeframe: Through study completion, an average of 2 years
2
Change from baseline length and diameter of the stenosis
Timeframe: From screening visit to week 52
3
Crohn's disease activity index (CDAI) questionnaire score
Timeframe: Through study completion, an average of 2 years
. antiTNF (for at least 14 week, include induction and/or maintenance doses): Infliximab, Adalimumab, Certolizumab.
. Anti-integrin (for at least 14 week, include induction and/or maintenance doses): Vedolizumab
. Anti-IL-12/23 (for at least 16 week, include induction and/or maintenance doses): Ustekinumab
Exclusion criteria
. Intra-abdominal abscesses larger than 3 cm not drained (surgically, by interventional radiology) or not treated with antibiotics. Patients may be included once the abscess has been drained (without the need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
. Several intestinal obstruction that requires urgent surgery
. Active outbreak of Crohn's disease requiring medical treatment, defined as abdominal pain, fever, bloody diarrhea and CRP greater than 10. The patient may be included once the condition has resolved, when the patient is on maintenance medication.
. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
. History in the last 6 month of several, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease
. Patients with primary sclerosing cholangitis
. Patients with known congenital or acquired immunodeficiency, including HIV
. Known allergy or hypersensibility to penicillin or aminoglycosides; DMEN (dulbecco modified eagle´s medium), bovine serum, local anesthesic or gadolinium