Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
Overview
- Phase
- Phase 1
- Intervention
- Autologous adipose derived mesenchymal stem cells
- Conditions
- Critical Limb Ischemia (CLI)
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diabetes, type 1 or 2
- •Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
- •No options for target limb revascularization.
Exclusion Criteria
- •Cancer antecedent in the last two years
- •Current limb infection or limb gangrene
Arms & Interventions
Mesenchymal stem cells 0,5 million * weight (kg)
Group of low dose of Mesenchymal stem cells.
Intervention: Autologous adipose derived mesenchymal stem cells
Mesenchymal stem cells 1 million * weight (kg)
Group of mid dose of mesenchymal stem cells
Intervention: Autologous adipose derived mesenchymal stem cells
Outcomes
Primary Outcomes
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
Time Frame: 6 months
Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.
Major adverse event (death, target limb amputation)
Time Frame: 1 month, 6 months, 12 months
Secondary Outcomes
- Ankle Brachial Index(1 month, 6 months, 12 months)
- University of Texas Classification at target limb(1 month, 6 months, 12 months)