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The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.
The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord mesenchymal stem cells | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells. | Amputation rate and mortality will be combined to report safty in % | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells. | Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pingping Huang, M.D. | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 13, 2023 | |
| Reset | Mar 13, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 13, 2023 | Mar 13, 2023 |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |