Local treatment in complex perianal fistulas in patients without inflammatory bowel disease
Conditions
Interventions
Product Name: Células troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Células troncales mesenquimales
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent - Perianal complex fistula with criptoglandular origin, that means fistula with some of the following circumstances: _Some grade of fecal incontinence _ Extra-sphincter fistula _Supra-sphincter fistula _Trans-sphnicter fistula _Patients both sexs elder than 18 years old. Good clinical condition, according to the patient medical notes and physical examination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient diagnosed with intestinal inflammatory disease. - Patients with abscess, unless a complete cleaning of the zone with drainage of the collections is done and the absence of abscess and other collections majors than 2 cm of maximum diameter is confirmed before initiating the treatment. - Antecedents of alcohol or other addictive substances abuse in the 6 months previous to the inclusion. - Malignant neoplasia, unless it is a skin basocelular or epidermoide carcinoma or antecedents of malignant tumors, unless they have been in remission phase during the 5 previous years. - Cardiopulmonary disease that, according to the investigator, is unstable or revista is sufficiently serious to discard the patient from the study. - Medical or psychiatric disease of any type that, according to the investigator, can suppose a reason for exclusion from the study. - Subjects with congenital or acquired immunodeficiencies. Hepatitis B and/or C or tuberculosis diagnosed during the inclusion - Greater surgery or serious traumatism of the patient in the previous semester. - Pregnant or breastfeeding women. - Adult women of childbearing age not using effective contraception during the trial. - Administration of any other drug in investigation at present or any time during the three months prior the recruitment for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the efficacy of autologous stem cells (ASC) plus fibrin glue versus fibrin glue for the closure of complex perianal fistulas not associated to inflammatory bowel disease. Fistula closure is defined as the absence of suppuration in the external orifice of the fistula and complete re-epithelialization of the external orifice en the clinic assesment.;Secondary Objective: Evaluate the safety in patients treated with ASC plus fibrin glue versus patients treated with only fibrin glue Evaluate the evolution of the clinical complexity of the fistula in the patients treated Evaluate the quality of life for both treatment groups (SF-12 score) Assess the fecal incontinence degree in both groups of patients (Wexner score). Evaluate the value of NMR in the follow-up of these patients;Primary end point(s): Study efficacy and safety;Timepoint(s) of evaluation of this end point: Once patient received treatment, 16 weeks after the last implantation and after 9 months of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluación de la calidad de vida de los pacientes yuna evaluación clínica del tratamiento Evaluación de recidiva: evaluación clínica;Timepoint(s) of evaluation of this end point: First one: After 16 weeks after last implantation. Second one: At 36 weeks after last implantation. | — |
Countries
Spain
Contacts
Public ContactMariano García Arranz
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Outcome results
None listed