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| Name | Class |
|---|---|
| Iniciativa Andaluza en Terapias Avanzadas | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells 0,5 million * weight (kg) | Active Comparator | Group of low dose of Mesenchymal stem cells. |
|
| Mesenchymal stem cells 1 million * weight (kg) | Active Comparator | Group of mid dose of mesenchymal stem cells |
|
| Controlled group | No Intervention | Controlled group with no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous adipose derived mesenchymal stem cells | Drug | Intra-arterial administration through a selective cannulation of target common femoral artery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafael J Ruiz-Salmeron, MD, PhD | University Hospital Virgen Macarena. Seville.Spain | Principal Investigator |
| Antonio De la Cuesta, MD | University Hospital Virgen Macarena. Seville.Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Virgen Macarena | Seville | Seville | 41007 | Spain | ||
| CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine) |
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| Seville |
| Seville |
| 41092 |
| Spain |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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