Overview

Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Criteria
Inclusion Criteria:

- Signed informed consent

- Extremely Complex perianal fistulae

- Men and women over 18 years old. Good general state of health according to the
findings of the clinical history and the physical examination

- Previous failure in at least one closing fistula standard treatment

Exclusion Criteria:

- Presence of severe proctitis or dominant active luminal disease requiring immediate
therapy

- 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 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 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 enrollment
into this clinical trial, any investigational drug