Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Critical Limb Ischemia (CLI), Diabetes

Intervention / Treatment
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* Drug: Autologous adipose derived mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesenchymal stem cells 0,5 million * weight (kg)<br>Group of low dose of Mesenchymal stem cells. | Drug: Autologous adipose derived mesenchymal stem cells<br>* Intra-arterial administration through a selective cannulation of target common femoral artery<br>|
| Active Comparator: Mesenchymal stem cells 1 million * weight (kg)<br>Group of mid dose of mesenchymal stem cells | Drug: Autologous adipose derived mesenchymal stem cells<br>* Intra-arterial administration through a selective cannulation of target common femoral artery<br>|
| No Intervention: Controlled group<br>Controlled group with no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis) | 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. | 6 months | 
| Major adverse event (death, target limb amputation) |  | 1 month, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle Brachial Index |  | 1 month, 6 months, 12 months | 
| University of Texas Classification at target limb |  | 1 month, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Limb Ischemia (CLI), Diabetes, Mesenchymal Stem Cells, Regenerative Therapy