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The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BM-ECs and PRPE | Experimental | Multipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE). |
|
| BM-ECs | Active Comparator | Intramuscular injection of bone marrow derived endothelial cells only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BM-ECs and PRPE | Biological |
| ||
| BM-ECs |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without major amputation | 6 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Perfusion rate in treated tissue by measure of ankle-brachial index (ABI) | Within 6 months after implantation | |
| Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2) | Within 6 months after implantation |
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Inclusion Criteria:
Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans)
18 Years to 80 Years (Adult, Senior);
Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
Patient meets at least one of the following diagnostic criteria for the index limb:
Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging;
Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery;
Unlikelihood of major amputation of the leg during the next 12 months;
Expected life span more than 2 years.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuetao Pei, M.D., Ph.D | Contact | 8610-68164807 | AMMS0906@163.com | |
| Fang Fang, Ph.D | Contact | 8620-89199011 | fangfang@scrm.org.cn |
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|
| Perfusion rate in treated tissue by digital subtraction angiography (DSA) | Within 6 months after implantation |
| wound size | Within 6 months after implantation |
| wound stage | Within 6 months after implantation |
| Pain intensity | Pain intensity using Visual Analogue Scale | Within 6 months after implantation |
| Thermography | Within 6 months after implantation |
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| D017719 | Diabetic Foot |
| D005734 | Gangrene |
| D016491 | Peripheral Vascular Diseases |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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