- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (MEIC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Lucia Llanos
- Phone Number: 3245 91 5504800
- Email: lucia.llanos@quironsalud.es
Study Contact Backup
- Name: Eva Cerezo
- Phone Number: 3214 91 5504800
- Email: eva.cerezo@quironsalud.es
Study Locations
-
-
-
Barcelona, Spain, 08035
- Not yet recruiting
- Hospital Universitario Valle de Hebrón
-
Contact:
- Marc Martí Gallostra
- Email: mmgallostra@vhebron.net
-
Madrid, Spain, 28040
- Recruiting
- Hospital Universitario Fundacion Jimenez Diaz
-
Contact:
- Dolores Herreros Marcos
- Email: dolores.herreros@quironsalud.es
-
Valencia, Spain, 46026
- Not yet recruiting
- Hospital Universitario y Politécnico La Fe
-
Contact:
- Mónica Millán Scheiding
- Email: monicamillan72@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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):
- 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
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Dose
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 |
adAMSC will be administered in the perilesional adipose tissue, through a laparoscopic procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of complications
Time Frame: Through study completion, an average of 2 years
|
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
Time Frame: From screening visit to week 52
|
according to RMI
|
From screening visit to week 52
|
Crohn's disease activity index (CDAI) questionnaire score
Time Frame: Through study completion, an average of 2 years
|
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 )
Time Frame: Through study completion, an average of 2 years
|
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
Time Frame: Through study completion, an average of 2 years
|
number of patients with an obstructive episode who required resection surgery
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dolores Herreros, Hospital Fundación Jiménez Díaz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJD-MEIC-21-01
- 2021-006068-26 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crohn Disease
-
ProgenaBiomeRecruitingCrohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Crohn's | Crohn Disease of Ileum | Crohn Ileitis | Crohn's Disease Relapse | Crohns Disease Aggravated | Crohn Disease in Remission | Crohn's Disease of PylorusUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CelltrionRecruitingBowel Disease | Inflammatory Disease | Disease CrohnNetherlands
-
Chinese University of Hong KongTerminatedCrohn Disease | Perianal Crohn DiseaseHong Kong
-
SandozCompletedCrohn´s DiseaseAustria, Germany, Poland, Spain, Sweden
-
Dr. Falk Pharma GmbHCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
Groupe Hospitalier Paris Saint JosephCompleted
-
Ferring PharmaceuticalsTerminatedCrohn´s DiseaseUnited Kingdom, United States, Germany, Belgium, Denmark, France, Sweden
-
Jinling Hospital, ChinaCompletedCrohn Disease in RemissionChina
-
Boehringer IngelheimTerminatedFibrostenotic Crohn´s DiseaseUnited States, Canada, Japan, Sweden
Clinical Trials on Adipose derived allogenic mesenchymal stem cells (adAMSC)
-
Aarhus University HospitalNot yet recruiting
-
Instituto de Investigación Hospital Universitario...UnknownRecto-vaginal FistulaSpain
-
Steminent Biotherapeutics Inc.Completed
-
Tehran University of Medical SciencesCompletedMultiple Sclerosis | Mesenchymal Stem Cells | Secondary-Progressive Multiple SclerosisIran, Islamic Republic of
-
Celltex Therapeutics CorporationNo longer available
-
Anterogen Co., Ltd.RecruitingCrohn DiseaseKorea, Republic of
-
Anterogen Co., Ltd.CompletedCrohnKorea, Republic of
-
Rigshospitalet, DenmarkCompletedChronic Ischemic Heart DiseaseDenmark
-
LaTonya J. HicksonActive, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus | Chronic Kidney Diseases | Diabetes Mellitus, Type 1 | Diabetic NephropathiesUnited States
-
Rigshospitalet, DenmarkCompletedDry Eye | Kerato Conjunctivitis Sicca | Aqueous Tear DeficiencyDenmark