Myocardial Ischemia Clinical Trial
Official title:
A 12-Month Follow-Up Study to Protocol 24779 (A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia [ACT34-CMI])
| NCT number | NCT00545610 |
| Other study ID # | 34976 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2007 |
| Est. completion date | June 2010 |
| Verified date | November 2018 |
| Source | Caladrius Biosciences, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | June 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 81 Years |
| Eligibility |
Inclusion Criteria: - Subjects who have received treatment with Auto-CD34+ cells or with placebo and who have completed the final study visit (Month 12) of the core therapeutic study 24779 - Subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Medical Group of St. Joseph´s | Atlanta | Georgia |
| United States | Cardiology, PC | Birmingham | Alabama |
| United States | Caritas St. Elizabeth´s Medical Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Northwestern University Medical School | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | The Lindner Clinical Trial Center | Cincinnati | Ohio |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Holy Cross Hospital | Fort Lauderdale | Florida |
| United States | University of Florida | Gainesville | Florida |
| United States | University of Iowa | Iowa City | Iowa |
| United States | University of Florida Health Science Center | Jacksonville | Florida |
| United States | Scripps Green Hospital / Scripps Clinical Hospital | La Jolla | California |
| United States | University of Wisconsin Medical School | Madison | Wisconsin |
| United States | Heart Care Associates, LLC | Milwaukee | Wisconsin |
| United States | Minneapolis Heart Institute | Minneapolis | Minnesota |
| United States | Cornell University | New York | New York |
| United States | New York Presbyterian Hospital | New York | New York |
| United States | Cardiovascular Institute Florida Hospital | Orlando | Florida |
| United States | Mayo Clinic Hospital | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Stanford University Hospital and Clinics | Stanford | California |
| United States | Washington Hospital Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Caladrius Biosciences, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Secondary | 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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