NCT05521672

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

Clinical Trial Phase IIa to Evaluate the Safety and Effectiveness of Treatment With Fat-derived Mesenchymal Allogenic Mesenchymal Troncal Cells in Patients With Single Inflammatory Stenosis in the Context of Crohn's Disease.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The hypothesis of the study is that the drug study administration will result in a anti-inflammatory effect, preventing the progression of the stenotic lesion and thus reducing the need to perform surgical resections. A multicentre, national, uncontrolled and open-label pilot study will be performed. 20 adult patients fulfilling eligibility criteria will be included. The trial is organized in screening period, treatment period and 6 follow-up visits. The treatment visit will be done in operating theatre, as the study drug is administrated by laparoscopy with a total dose of 120 million cells prepared in a saline solution with a cell concentration of 10 million cells per millilitre. Follow-up visits are divided into 4 visits that will take place every 6 weeks (+-7 days) until week 24; 1 additional follow-up visit will take place at week 36 and the last one at week 52. Analytical controls (blood count, biochemistry and coagulation) will be carried out throughout the trial and biological samples will be taken in three visits (Screening, visit 3 and visit 6). Abdominal MRI will be performed at baseline and in the end of study visit, to assess stenosis evolution. The overall duration of the trial is 36 months from the start of recruitment to the last follow-up visit. The period planned for this trial is from september 2022 to september 2025.

Conditions

• Stenosis; Bowel
• Crohn Disease

Interventions

Type	Name	Description
DRUG	Adipose derived allogenic mesenchymal stem cells (adAMSC)	adAMSC will be administered in the perilesional adipose tissue, through a laparoscopic procedure

Timeline

• Start date: 2022-10-24
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2022-08-30
• Last updated: 2025-03-20

Locations

3 sites across 1 country: Spain