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

NCT05521672 | Terminated Phase 1

• 2 other identifiers: FJD-MEIC-21-012021-006068-26
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stenosis; Bowel; Crohn Disease

Outcome Measures

Primary Outcomes (5)

• Percentage of complications

  Number of complication associated with presurgery, surgery, IMP administration and postsurgery period

  Through study completion, an average of 2 years

• Change from baseline length and diameter of the stenosis

  according to RMI

  From screening visit to week 52

• Crohn's disease activity index (CDAI) questionnaire score

  Change from baseline in Crohn's disease activity index (CDAI) score (0-1100 points). Higher scores mean a worse outcome.

  Through study completion, an average of 2 years

• inflammatory bowel disease questionnaire (IBDQ32 )

  Change from baseline in inflammatory bowel disease questionnaire (IBDQ32 ). 140-200 points, higher scores mean a better outcome.

  Through study completion, an average of 2 years

• patients with an obstructive episode who required resection surgery

  number of patients with an obstructive episode who required resection surgery

  Through study completion, an average of 2 years

Study Arms (1)

Single Dose

EXPERIMENTAL

This is an uncontrolled trial, phase IIa, proof of concept. Group control has not been included. All patients will receive one single dose of 120 million cells

Drug: Adipose derived allogenic mesenchymal stem cells (adAMSC)

Interventions

Adipose derived allogenic mesenchymal stem cells (adAMSC) DRUG

adAMSC will be administered in the perilesional adipose tissue, through a laparoscopic procedure

Single Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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
• Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraceptive measures for the duration of their participation in the study\*
• a woman is considered to be of childbearing potential (WOCBP), that is, fertile, after menarche and until she becomes postmenopausal, unless she is permanently infertile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
• Highly effective methods are considered: combined hormonal contraception (containing estrogens and progestogens) associated with ovulation inhibition (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with ovulation inhibition (oral, injectable, implantable ), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence

You may not qualify if:

• 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
• Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia).
• Patients unwilling or unable to comply with study procedures.
• 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.
• Pregnant or lactating women.
• Patients who have a contraindication for general anesthesia.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (3)

Hospital Universitario Valle de Hebrón

Barcelona, 08035, Spain

Location

Hospital Universitario Fundación Jiménez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Constriction, Pathologic; Crohn Disease

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dolores Herreros

  Hospital Fundación Jiménez Diaz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: October 24, 2022
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

ES (3)