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ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00545610
First received: October 16, 2007
Last updated: July 9, 2010
Last verified: July 2010
  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])

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545610

  Show 23 Study Locations
Sponsors and Collaborators
Baxter Healthcare Corporation
  More Information

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:
Coronary Artery Disease
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014