A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of lamparoscopic administration of allogenic mesenchymals stem cell (adMSC) extracted by lipoaspirate from healthy patients, for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

22 Oct 2022 → 13 Dec 2024

Decision date (initial)

2023-07-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-507108-30-00

EudraCT number

2021-006068-26

ClinicalTrials.gov

NCT05521672

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the feasibility and safety of laparoscopic administration of allogeneic adMSCs for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease.

Secondary objectives 2

1. To assess preliminary treatment efficacy
2. To evaluate changes in the quality of life of treated patients using the IBDQ32 questionnaire

Conditions and MedDRA coding

Crohn's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients who agree to participate and agree to give their written consent
2. Patients over 18 years of age and under 75 years of age
3. With Crohn's disease diagnosed at least 6 months earlier who meet clinical, endoscopic, histological and/or radiological criteria
4. Presence of a single inflammatory stenotic lesion in the small bowel or ileocolic area or anastomotic area of the small bowel or ileocolic area, either recent, or in the context of inflammatory recurrence, with a maximum length of 10 cm, demonstrated by enteroresonance, resulting in episodes of intestinal occlusion/subocclusion. Other inflammatory lesions are acceptable, but only one lesions are acceptable, but only one should be identified as the obvious cause of the occlusion/subocclusion. occlusion/subocclusion
5. Patients treated with at least one biologic drug and with inadequate response to maintenance doses and prior to intensification (either dose, interval or change/addition of another drug): a. anti-TNF (for at least 14 weeks, which includes induction and/or maintenance doses): Infliximab, Adalimumab, Certolizumab. b. Anti-integrin(at least for 14 weeks, which includes induction and/or maintenance doses): Vedolizumab c. Anti-IL-12/23(at least for 16 weeks, which includes induction and/or maintenance doses): Ustekinumab
6. Women of childbearing age must have a negative pregnancy test at screening and agree to use effective contraceptive measures for the duration of their participation in the study

Exclusion criteria 14

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 (no need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
2. Severe intestinal obstruction requiring urgent surgery.
3. Active Crohn's disease flare-up 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 can be included.
5. History in the last 6 months of severe, progressive or uncontrolled hepatic, hematologic, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurologic or psychiatric disease.
6. Patients with primary sclerosing cholangitis.
7. Patients with known congenital or acquired immune deficiency, including HIV.
8. Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.
9. Contraindication to perform MRI (pacemaker, hip prosthesis or severe claustrophobia) or receive contrast with gadolinium.
10. Patients unwilling or unable to comply with the 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 breastfeeding women.
14. Patients with contraindications for general anesthesia, locoregional anesthesia (depending on the type of anesthesia required) or laparoscopic surgery.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. proportion and type of complications arising from treatment (adverse reactions) Complications during anesthesia
2. Complications arising from the treatment administration procedure

Secondary endpoints 4

1. To evaluate the change in the length of the stenosis with respect to the basal in the enteroresonance.
2. To evaluate the change in the CDAI questionnaire score from baseline at 6, 12, 18, 24, 36 and 52 weeks.
3. To assess the change in score from baseline on the IBDQ32 questionnaire at 6, 12, 18, 24, 24, 36 and 52 weeks after treatment
4. Describe the number of patients with obstructive episode who required resection surgery during the study period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Sponsor organisation

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Address

Calle De Isaac Peral 42 Oficinas 2a Planta Oficina 1

City

Madrid

Postcode

28015

Country

Spain

Scientific contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Contact name

Lucia Llanos Jiménez

Public contact point

Organisation

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz

Contact name

Lucia Llanos Jiménez

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications