Clinical trial NCT01586715: Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)
Official title: A Phase IIa Clinical Trial to Study the Treatment of the Extremely Complex and Conventional Treatment Resistant Perianal Fistulae With Autologous Stem Cells From Lipoaspirate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extremely Complex Perianal Fistulae
Keywords: Extremely complex perianal fistula
Adipose Derived Stem Cells
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of life assessment using the SF-12 Questionnaire
timeFrame: 1, 4, 16,24 weeks
measure: Adverse events
timeFrame: 1, 4, 12, 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory
name: Damián García Olmo, Prof MD
role: PRINCIPAL_INVESTIGATOR
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