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NCT05521672CompletedPhase 2

A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of lamparoscopic administration of allogenic mesenchymals stem cell (adMSC) extracted by lipoaspirate from healthy patients, for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease.

A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of lamparoscopic administration of allogenic mesenchymals stem cell (adMSC) extracted by lipoaspirate from healthy patients, for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease. SM

Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Mar 2024

Brief summary (registry, in English)

To evaluate the feasibility and safety of laparoscopic administration of allogeneic adMSCs for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (actual)
First submitted
18 Jul 2023
Start date
22 Oct 2022
Lead sponsor
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
NCT number
NCT05521672
EU CT number
2023-507108-30-00
EudraCT number
2021-006068-26

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 20
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 (no need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
  • Patients who are receiving, or have received, any investigational drug in the 3 months prior to the screening period.
  • Major surgery or severe trauma in the previous 6 months
  • Patients with contraindications for general anesthesia, locoregional anesthesia (depending on the type of anesthesia required) or laparoscopic surgery.
  • Severe intestinal obstruction requiring urgent surgery.

Other illness

  • Active Crohn's disease flare-up 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 can be included.
  • History in the last 6 months of severe, progressive or uncontrolled hepatic, hematologic, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurologic or psychiatric disease.
  • Patients with known congenital or acquired immune deficiency, including HIV.

Lab values

  • Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.

Other

  • Patients unwilling or unable to comply with the study procedures.
  • Pregnant or breastfeeding women.
  • Patients with primary sclerosing cholangitis.
  • Contraindication to perform MRI (pacemaker, hip prosthesis or severe claustrophobia) or receive contrast with gadolinium.

Who the study is looking for

  • Patients who agree to participate and agree to give their written consent
  • Patients over 18 years of age and under 75 years of age
  • With Crohn's disease diagnosed at least 6 months earlier who meet clinical, endoscopic, histological and/or radiological criteria
  • Presence of a single inflammatory stenotic lesion in the small bowel or ileocolic area or anastomotic area of the small bowel or ileocolic area, either recent, or in the context of inflammatory recurrence, with a maximum length of 10 cm, demonstrated by enteroresonance, resulting in episodes of intestinal occlusion/subocclusion. Other inflammatory lesions are acceptable, but only one lesions are acceptable, but only one should be identified as the obvious cause of the occlusion/subocclusion. occlusion/subocclusion
  • Patients treated with at least one biologic drug and with inadequate response to maintenance doses and prior to intensification (either dose, interval or change/addition of another drug): a. anti-TNF (for at least 14 weeks, which includes induction and/or maintenance doses): Infliximab, Adalimumab, Certolizumab. b. Anti-integrin(at least for 14 weeks, which includes induction and/or maintenance doses): Vedolizumab c. Anti-IL-12/23(at least for 16 weeks, which includes induction and/or maintenance doses): Ustekinumab
  • Women of childbearing age must have a negative pregnancy test at screening and agree to use effective contraceptive measures for the duration of their participation in the study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainCompleted
Institut D Investigacio Sanitaria Pere Virgili
Coordinator of this site? Confirm its status
TarragonaSpainCompleted
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainCompleted

This page is information, not medical advice. Discuss any trial with your doctor.