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

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rectovaginal Fistula; Crohn Disease

Treatments: Drug: Expanded allogenic adipose-derived adult stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00999115

EC08/00153

EudraCT: 2009-010225-39

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Allogenic ASCs

Experimental group

Description:

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.

Treatment:

Drug: Expanded allogenic adipose-derived adult stem cells