Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Extremely Complex Perianal Fistulae

Intervention / Treatment
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* Drug: Adipose-derived stem cells without expanded


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Stem Cells<br> | Drug: Adipose-derived stem cells without expanded<br>* Administration will be intralesional injection of cells suspension. They will be placed into fistula walls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae | Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound | 16 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extremely complex perianal fistula, Adipose Derived Stem Cells