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The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLX-PAD low dose | Experimental | IM injection Single treatment; multiple injections |
|
| PLX-PAD high dose | Experimental | IM injection Double treatment; multiple injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLX-PAD | Biological | IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence | 3 months | |
| Immunological reaction | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology PC | Birmingham | Alabama | 35211 | United States | ||
| Duke University Medical Center |
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| Durham |
| North Carolina |
| 27710 |
| United States |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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