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The purpose of this 12-month, observational, follow-up study is to collect additional data (by telephone contact) with which to assess the efficacy, safety, and effects of intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in subjects with chronic refractory myocardial ischemia. No treatments will be administered during this study. However, the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so as to provide a total of 24 months of blinded data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 (n=50) | 1 x 10^5 (+/-10%) CD34+ cells/kg of body weight | ||
| Test 2 (n=50) | 5 x 10^5 (+/-10%) CD34+ cells/kg of body weight | ||
| Placebo (n=50) | Saline plus 5% autologous plasma |
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| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of intramyocardial injections of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia over a 12-month follow-up period. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term efficacy of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia and the effects of this treatment on quality of life (QoL) over a 12-month follow-up period | 12 months |
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Inclusion Criteria:
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Subjects who have received treatment with Auto-CD34+ cells (1 x 10^5 (+/-10%) CD34+ cells/kg or 5 x 10^5 (+/-10%) CD34+ cells/kg)or with placebo (saline plus 5% autologous plasma) and who have completed the final study visit (Month 12) of the core therapeutic study 24779
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| Name | Affiliation | Role |
|---|---|---|
| Caladrius Study Director | Lisata Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, PC | Birmingham | Alabama | United States | |||
| Mayo Clinic Hospital |
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| Phoenix |
| Arizona |
| United States |
| Scripps Green Hospital / Scripps Clinical Hospital | La Jolla | California | 92037 | United States |
| Stanford University Hospital and Clinics | Stanford | California | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | United States |
| University of Florida | Gainesville | Florida | United States |
| University of Florida Health Science Center | Jacksonville | Florida | United States |
| Cardiovascular Institute Florida Hospital | Orlando | Florida | United States |
| The Medical Group of St. Joseph´s | Atlanta | Georgia | United States |
| Northwestern University Medical School | Chicago | Illinois | United States |
| Rush University Medical Center | Chicago | Illinois | United States |
| University of Iowa | Iowa City | Iowa | United States |
| Caritas St. Elizabeth´s Medical Center | Boston | Massachusetts | United States |
| Massachusetts General Hospital | Boston | Massachusetts | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Cornell University | New York | New York | United States |
| New York Presbyterian Hospital | New York | New York | United States |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Wisconsin Medical School | Madison | Wisconsin | United States |
| Heart Care Associates, LLC | Milwaukee | Wisconsin | United States |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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