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Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group. In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
University Hospital Virgen Macarena
Seville, Seville, Spain
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, Seville, Spain
Start Date
December 1, 2010
Primary Completion Date
February 1, 2013
Completion Date
July 1, 2015
Last Updated
August 5, 2015
33
ACTUAL participants
Autologous adipose derived mesenchymal stem cells
DRUG
Lead Sponsor
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07296484