Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Unknown; Phase 2

Conditions: Extremely Complex Perianal Fistulae

Treatments: Drug: Adipose-derived stem cells without expanded

Study type: Interventional

Funder types: Other

Identifiers

NCT01586715

HULPCIR-2010-01

2010-024329-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Autologous Stem Cells

Experimental group

Treatment:

Drug: Adipose-derived stem cells without expanded