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| ID | Type | Description | Link |
|---|---|---|---|
| 11931-02 | Other Identifier | Sponsor protocol number |
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Active Comparator |
| |
| High Dose | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD34-positive cells | Biological |
| ||
| CD34-positive cells |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Intramuscular Injection of CD34-positive cells | 6 months and 1 year | |
| Change in Rest Pain | 6 months | |
| Ulcer Healing | 6 months | |
| Functional Improvement | 6 months | |
| Limb Salvage | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Severity | 6 months | |
| Assessment of Co-morbidity | 6 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 | ||
| Florida Research Network LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35802393 | Derived | Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4. | |
| 23192920 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2012 | |
| Reset | May 21, 2012 | |
| Release | Jun 12, 2012 |
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|
| Saline and 5% autologous plasma | Biological |
|
| Gainsville |
| Florida |
| 32605 |
| United States |
| Orlando Regional Medical Center | Orlando | Florida | 32806 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mount Sinai School of Medicine Division of Vascular Surgery | New York | New York | 10029 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| University Hospitals of Cleveland, Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Utah-Vascular Surgery Division | Salt Lake City | Utah | 84132 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Comprehensive Cardiovascular Care St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27. |
| Reset | Jul 13, 2012 |
| Release | Mar 30, 2015 |
| Reset | Apr 14, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2012 | May 21, 2012 | |||
| Jun 12, 2012 | Jul 13, 2012 | |||
| Mar 30, 2015 | Apr 14, 2015 |
| 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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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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