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 — MEIC

Crohn Disease Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05521672
Study type	Interventional
Source	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Contact	Lucia Llanos
Phone	91 5504800
Email	lucia.llanos@quironsalud.es
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	October 24, 2022
Completion date	June 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.