ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)
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Purpose
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.
| Condition |
|---|
|
Myocardial Ischemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| 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]) |
- 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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 21 Years to 81 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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
Contacts and Locations
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No publications provided
| Responsible Party: | Kari Brown, Clinical Project Manager, Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00545610 History of Changes |
| Other Study ID Numbers: | 34976 |
| Study First Received: | October 16, 2007 |
| Last Updated: | July 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013