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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00999115
• Date of registration: 20/10/2009
• Prospective Registration: No
• Primary sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Public title: Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA) ALOREVA
• Scientific title: 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
• Date of first enrolment: September 2009
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00999115
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Spain

Contacts

• Name: Damián García Olmo, MD
• Affiliation: General Surgery Department, Hospital Universitario La Paz

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Crohn Disease

Rectovaginal Fistula

Intervention(s)

Drug: Expanded allogenic adipose-derived adult stem cells

Primary Outcome(s)

Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed [Time Frame: 12 weeks]

Secondary Outcome(s)

Clinically relevant variations in laboratory test [Time Frame: 1, 4 8, 12, 24, 54 weeks]

Quality of life assessment using the SF-36 questionnaire [Time Frame: 24 weeks]

Quality of life assessment using the SF-36 questionnaire [Time Frame: 12 weeks]

Adverse events [Time Frame: 1, 4, 8,12, 24, 54 weeks]

Secondary ID(s)

EC08/00153

EudraCT: 2009-010225-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors