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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)

Primary Purpose

Stenosis; Bowel, Crohn Disease

Status
Recruiting
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Adipose derived allogenic mesenchymal stem cells (adAMSC)
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stenosis; Bowel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who agree to participate and agree to give their written consent.
  2. Patients older than 18 years and younger than 75 years
  3. With Crohn's disease diagnosed at least 6 months before that meet clinical, endoscopic, histological and/or radiological criteria.
  4. 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.
  5. 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):

    1. antiTNF (for at least 14 week, include induction and/or maintenance doses): Infliximab, Adalimumab, Certolizumab.
    2. Anti-integrin (for at least 14 week, include induction and/or maintenance doses): Vedolizumab
    3. Anti-IL-12/23 (for at least 16 week, include induction and/or maintenance doses): Ustekinumab
  6. 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:

  1. 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.
  2. Several intestinal obstruction that requires urgent surgery
  3. 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.
  4. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
  5. History in the last 6 month of several, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease
  6. Patients with primary sclerosing cholangitis
  7. Patients with known congenital or acquired immunodeficiency, including HIV
  8. Known allergy or hypersensibility to penicillin or aminoglycosides; DMEN (dulbecco modified eagle´s medium), bovine serum, local anesthesic or gadolinium
  9. Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia).
  10. Patients unwilling or unable to comply with study procedures.
  11. Patients who are receiving or have received any investigational drug in the 3 months prior to the screening period
  12. Major surgery or severe trauma in the previous 6 months.
  13. Pregnant or lactating women.
  14. Patients who have a contraindication for general anesthesia.

Sites / Locations

  • Hospital Universitario Valle de Hebrón
  • Hospital Universitario Fundación Jiménez DiazRecruiting
  • Hospital Universitario y Politécnico La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Dose

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of complications
Number of complication associated with presurgery, surgery, IMP administration and postsurgery period
Change from baseline length and diameter of the stenosis
according to RMI
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.
inflammatory bowel disease questionnaire (IBDQ32 )
Change from baseline in inflammatory bowel disease questionnaire (IBDQ32 ). 140-200 points, higher scores mean a better outcome.
patients with an obstructive episode who required resection surgery
number of patients with an obstructive episode who required resection surgery

Secondary Outcome Measures

Full Information

First Posted
August 22, 2022
Last Updated
July 5, 2023
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Effice Servicios Para la Investigacion S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT05521672
Brief Title
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
Acronym
MEIC
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Effice Servicios Para la Investigacion S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis; Bowel, Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Dose
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Adipose derived allogenic mesenchymal stem cells (adAMSC)
Intervention Description
adAMSC will be administered in the perilesional adipose tissue, through a laparoscopic procedure
Primary Outcome Measure Information:
Title
Percentage of complications
Description
Number of complication associated with presurgery, surgery, IMP administration and postsurgery period
Time Frame
Through study completion, an average of 2 years
Title
Change from baseline length and diameter of the stenosis
Description
according to RMI
Time Frame
From screening visit to week 52
Title
Crohn's disease activity index (CDAI) questionnaire score
Description
Change from baseline in Crohn's disease activity index (CDAI) score (0-1100 points). Higher scores mean a worse outcome.
Time Frame
Through study completion, an average of 2 years
Title
inflammatory bowel disease questionnaire (IBDQ32 )
Description
Change from baseline in inflammatory bowel disease questionnaire (IBDQ32 ). 140-200 points, higher scores mean a better outcome.
Time Frame
Through study completion, an average of 2 years
Title
patients with an obstructive episode who required resection surgery
Description
number of patients with an obstructive episode who required resection surgery
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Llanos
Phone
91 5504800
Ext
3245
Email
lucia.llanos@quironsalud.es
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Cerezo
Phone
91 5504800
Ext
3214
Email
eva.cerezo@quironsalud.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores Herreros
Organizational Affiliation
Hospital Fundación Jiménez Diaz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Valle de Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Martí Gallostra
Email
mmgallostra@vhebron.net
Facility Name
Hospital Universitario Fundación Jiménez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Herreros Marcos
Email
dolores.herreros@quironsalud.es
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mónica Millán Scheiding
Email
monicamillan72@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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