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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001825-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministry of Health, Czech Republic | OTHER_GOV |
| Regional Council of the Moravian-Silesian region, KU MSK | UNKNOWN |
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The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out differences among three different therapeutic types of BMAC application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.
Secondary hypothesis assumes, that the intravenous application of BMAC in patients with T2DM older than 30 years of age, with a dose of insulin exceeding 0.7 U/kg/day or 50U/day will result in decreasing the insulin dose in the course of 6-month follow-up and in an improvement of the glycHBA1c levels, improvement of the liver and kidney function, decrease of the cholesterol levels and improvement of the immune response parameters, i.e. parameters of lymphocytar blastic transformation, more than in case of patients with intramuscular or intraarterial application of BMAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Intramuscular | Experimental | Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml. The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes. |
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| Group B: Intraarterial | Experimental | Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb. |
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| Group C: Intravenous | Experimental | Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb. |
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| Group D: Control-standard treatment | Other | Group D: Control Group Study subjects in Group D will receive a standard treatment for NO-option CLI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A: Intramuscular | Biological | Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml. The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Amputation-free survival | The data for Primary outcome will be collected throughout the first 18 months of the study. The assessed parameters will include amputation-free survival in order to verify the safety and efficacy of the treatment. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue perfusion parameters | The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups. | The immune response of study subjects will be monitored following the transplantation of stem cells, together with the periphery lymphocyte function (T-cells, B-cells, NK-cells). Immune response parameters, (i.e. parameters of lymphocytar blastic transformation) | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vaclav Prochazka, MD, PhD, MSc | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | 708 52 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10777239 | Background | Dormandy J, Heeck L, Vig S. The natural history of claudication: risk to life and limb. Semin Vasc Surg. 1999 Jun;12(2):123-37. | |
| 15714369 | Background | Clair DG, Dayal R, Faries PL, Bernheim J, Nowygrod R, Lantis JC 2nd, Beavers FP, Kent KC. Tibial angioplasty as an alternative strategy in patients with limb-threatening ischemia. Ann Vasc Surg. 2005 Jan;19(1):63-8. doi: 10.1007/s10016-004-0136-0. |
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| Group B: Intraarterial | Biological | Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb. |
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| Group C: Intravenous | Biological | Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb. |
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| Group D: Surgical endovascular treatment with maximum medicamentous treatment | Procedure | Group D: Control Group Control Group - no experimental intervention, standard endovascular treatment or bypass surgery or maximum medicamentous treatment |
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| 4 years |
| Clinical outcome classification | The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial. - Improvement of the Rutherford scale of CLI | 4 years |
| Functional angiogenesis imaging outcome | The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial. - Increase of the number and quality of newly created vessels measured according to digital subtraction angiography (DSA) or MR-angiography (in allergic patients) | 4 years |
| Quality of life outcome | The efficacy of BMAC application will be evaluated throughout the whole course of the clinical trial, with final assessment at the end of the trial.
| 4 years |
| Metabolic response | The following laboratory parameters throughout the clinical trial:
| 24 months |
| Blood glucose and pancreatic function response | The following parameters will be monitored in the study subjects:
| 24 months |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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