Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

Phase 2

• Conditions: Extremely Complex Perianal Fistulae
• Interventions: Drug: Adipose-derived stem cells without expanded

• Registration Number: NCT01586715
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-25
• Last Update Submitted: 2012-04-25
• Study First Posted: 2012-04-27
• Last Update Posted: 2012-04-27
• Primary Completion: 2013-05
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Stem Cells	Adipose-derived stem cells without expanded	-

Primary Outcome Measures

Name	Time	Method
Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae	16 weeks	Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment using the SF-12 Questionnaire	1, 4, 16,24 weeks	Test SF-12 of quality of life
Adverse events	1, 4, 12, 24 weeks	Control by investigation team of CRD (data collections)

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain