Stenosis; BowelPhase 1/2MEICNCT05521672
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
A Phase 1/2 study testing Adipose derived allogenic mesenchymal stem cells (adAMSC) in people with Stenosis; Bowel and Crohn Disease, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stenosis; Bowel, Crohn Disease
- What is being tested?
- Adipose derived allogenic mesenchymal stem cells (adAMSC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesSpain
- Study dates
- 24 Oct 2022to 13 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario Valle de Hebrón
Barcelona, 08035
Hospital Universitario Fundación Jiménez Diaz
Madrid, 28040
Hospital Universitario y Politécnico La Fe
Valencia, 46026
About this study
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.
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.
Read the 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
- Being tested
- Adipose derived allogenic mesenchymal stem cells (adAMSC)
- Medical subject headings
- Constriction, Pathologic, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose derived allogenic mesenchymal stem cells (adAMSC)Drug
adAMSC will be administered in the perilesional adipose tissue, through a laparoscopic procedure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Adipose derived allogenic mesenchymal stem cells (adAMSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of complications
Number of complication associated with presurgery, surgery, IMP administration and postsurgery period
Measured: Through study completion, an average of 2 years
Change from baseline length and diameter of the stenosis
according to RMI
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start24 Oct 2022
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis; BowelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
- Investigators
- Dolores Herreros, Principal investigator, Hospital Fundación Jiménez Diaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521672
- Sponsor's protocol ID
- FJD-MEIC-21-01
- Other IDs
- 2021-006068-26
- Acronym
- MEIC
- Status last verified
- Mar 2025
- First submitted
- 22 Aug 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05521672
- Acronym / sponsor ID
- MEIC / FJD-MEIC-21-01
- Conditions
- Stenosis; Bowel, Crohn Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Dose | Experimental | Drug: Adipose derived allogenic mesenchymal stem cells (adAMSC)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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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):
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose derived allogenic mesenchymal stem cells (adAMSC)adAMSC will be administered in the perilesional adipose tissue, through a laparoscopic procedure | Drug | Single Dose |
Primary outcome
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
Change from baseline length and diameter of the stenosis
Time frame: From screening visit to week 52
according to RMI
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.
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.
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
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dolores Herreros principal investigator
Hospital Fundación Jiménez Diaz
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adipose derived allogenic mesenchymal stem cells (adAMSC) in people with Stenosis; Bowel and Crohn Disease, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of complications (time frame: Through study completion, an average of 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.