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