Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)

Study Overview
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Brief Summary
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The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.

Official Title
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Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease

Conditions
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Rectovaginal Fistula, Crohn Disease

Intervention / Treatment
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* Drug: Expanded allogenic adipose-derived adult stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Patients with Crohn´s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria. Fulfilling one of the following criteria: At least, one previous surgery for fistulous disease. Physical status which discourage liposuction. Rectovaginal fistula. Women of a childbearing age. Good general state of health according to the findings of the clinical history and the physical examination. Exclusion Criteria: Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy Patients with CDAI≥201 Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start Patients who have received infliximab or any other anti TNF agent in the 8 weeks before the cell treatment administration Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study. Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent. Patients allergic to local anesthetics or gadolinium (MRI contrast) MRI is unfeasible (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia) Patients who have suffering major surgery or severe trauma in the prior 6 months Pregnant or breastfeeding women Patients currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogenic ASCs<br>Intralesional dose of 20 million cells at baseline with a possible second administration of 40 million in case of incomplete fistula closure following week 12 assessment. | Drug: Expanded allogenic adipose-derived adult stem cells<br>* Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach.<br>* Other names: CX601 (company code);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment using the SF-36 questionnaire |  | 12 weeks | 
| Adverse events |  | 1, 4, 8,12, 24, 54 weeks | 
| Clinically relevant variations in laboratory test |  | 1, 4 8, 12, 24, 54 weeks | 
| Quality of life assessment using the SF-36 questionnaire |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectovaginal Fistula, Crohn Disease, Allogenic, Adipose-Derived Stem Cells