We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545610
First Posted: October 17, 2007
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shire
  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 Shire:

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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545610


  Show 23 Study Locations
Sponsors and Collaborators
Baxalta now part of Shire
  More Information

Responsible Party: Kari Brown, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00545610     History of Changes
Other Study ID Numbers: 34976
First Submitted: October 16, 2007
First Posted: October 17, 2007
Last Update Posted: October 23, 2017
Last Verified: July 2010

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases