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
Drug: Adipose-derived stem cells without expanded
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Locations near you
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Full eligibility criteria for NCT01586715
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01586715
Hospital Universitario La Paz
Madrid, Spain, 28046
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View full eligibility
Tris trial is registered with FDA with number: NCT01586715. The sponsor of the trial is Instituto de Investigación Hospital Universitario La Paz and it is looking for 10 volunteers for the current phase.
Official trial 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
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