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Patients' numebr randomized not achieved. Investigators team with lack of interest and commitment. The sponsor closed prematurely patients' recruitment.
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| Name | Class |
|---|---|
| Iniciativa Andaluza en Terapias Avanzadas | OTHER |
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To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and the decrease of the needs of insulin, besides evaluates the safety, viability and efficiency of the intra-arterial infusion of stem cells in diabetic patients type 2 with CLI.
To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and the decrease of the needs of insulin, besides evaluates the safety, viability and efficiency of the intra-arterial infusion of stem cells in diabetic patients type 2.
Diabetic patients will include with critical ischemia chronicle of at least a low member limb (CLI) and without possibilities of revascularization. 48 evaluable patients will be included, of which 36 patients will be included in the experimental group (12 for every cellular group) and 12 in the group control by conventional treatment. The population to studying will be constituted by 48 evaluable patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous mononuclear stem cell from the bone marrow | Experimental | Autologous mononuclear stem cell from the bone marrow in an unique infusion of 150-250 millions of cells |
|
| Autologous endothelial stem cell from the bone marrow | Experimental | Autologous endothelial progenitor CD133 stem cell from the bone marrow in an unique infusion of 2 - 7 millions of CD133 cells |
|
| Autologous mesenchymal stem cells from the adiposite tissue | Experimental | Autologous mesenchymal stem cells from the adipose tissue in an unique infusion of 0.5 millions of cells |
|
| Current medication for the disease | Active Comparator | Current medication for the disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cell infusion | Drug | Unique stem cell infusion of the randomized group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | To evaluate the possible complications derived from the procedure (in the first 24 hours after the infusion of stem cells and the incident of Serious Adverse Events and not Serious Adverse Events related to the IMPD or to the procedure of administration | the entire follow-up period, in the first 24 hours after the infusion of stem cells |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy measured by: The changes in the requirements of insulin, Peptide C, Resistance to the insulin, inflammatory Cytokines, pancreatic Reservation, Quantification of the degree of neovascularization (angio/arteriogenesis and vasculogenesis) | Efficacy measured by: The changes in the requirements of insulin, Peptide C, Resistance to the insulin, inflammatory Cytokines, pancreatic Reservation, Quantification of the degree of neovascularization (angio/arteriogenesis and vasculogenesis) after 6 months of the stem cells infusion |
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Inclusion Criteria:
Age ≥18 and ≤ 85 years
Diabetic type 2, in treatment with insulin at least 3 previous months.
Vascular disease infrapopliteal atherosclerotic of severe degree (Patients with category Rutherford-Becker ≥ 4), pretty or bilateral. The critical ischemia of the foot is defined as a persistent / persistent pain that needs analgesia and / or not healing present sores> 4 weeks, without evidence of improvement with conventional therapies and / or walking test between 1-6 minutes in two ergometries separated at least for 2 weeks and / or index ankle - arm in rest <0,8.
Impossibility of revascularization surgical or endovascular or I fail in the surgery of revascularization performed at least 30 days before, with persistence or entry in phase of critical ischemia
Life expectancy > 2 years.
Major amputation is not foreseen in any of the members in the next 6 months after the incorporation.
Normal Biochemical and bone marrow parameters defined for:
The women in fertile age will have to obtain negative results in a pregnancy test realized in the moment of the incorporation in the study and promise to use a contraceptive method medically approved while the study lasts.
Patients who give his Informed Consent in writing for the participation in the study. 10. Patients who have not taken part in another clinical trial in the last 3 months before the incorporation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernat Soria | CABIMER (Centro Andaluz de BiologÃa Molecular y Medicina Regenerativa) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopsital U. Virgen Macarena | Seville | Seville | 41007 | Spain | ||
| CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine) |
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| 6 months |
| Seville |
| 41092 |
| Spain |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| 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 |
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