Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)

This study has been completed.
Sponsor:
Collaborators:
Cardiovascular Cell Therapy Research Network (CCTRN)
Information provided by (Responsible Party):
Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00824005
First received: January 15, 2009
Last updated: April 2, 2013
Last verified: April 2013
Results First Received: August 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Chronic Ischemic Heart Disease
Left Ventricular Dysfunction
Angina
Ischemic Cardiomyopathy
Interventions: Biological: Adult stem cells
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment took place at five Network centers and their associated satellite facilities between April 29, 2009 and April 18, 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Injections Participants will receive placebo injections.
Active Stem Cell Injections Participants will receive active stem cell injections.

Participant Flow:   Overall Study
    Placebo Injections     Active Stem Cell Injections  
STARTED     31     61  
COMPLETED     31     59  
NOT COMPLETED     0     2  
Death                 0                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Injections Participants will receive placebo injections.
Active Stem Cell Injections Participants will receive active stem cell injections.
Total Total of all reporting groups

Baseline Measures
    Placebo Injections     Active Stem Cell Injections     Total  
Number of Participants  
[units: participants]
  31     61     92  
Age  
[units: years]
Mean ± Standard Deviation
  62.32  ± 8.25     63.95  ± 10.90     63.4  ± 10.1  
Gender  
[units: participants]
     
Female     2     8     10  
Male     29     53     82  
Region of Enrollment  
[units: participants]
     
United States     31     61     92  



  Outcome Measures
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1.  Primary:   Change in Maximal Oxygen Consumption (VO2max)   [ Time Frame: Measured at Baseline and Month 6 ]

2.  Primary:   Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo   [ Time Frame: Measured at Baseline and Month 6 ]

3.  Primary:   Change in Reversible Defect Size   [ Time Frame: Measured at Baseline and Month 6 ]

4.  Secondary:   Regional Wall Motion by MRI (in Eligible Patients)   [ Time Frame: Measured at Baseline and Month 6 ]

5.  Secondary:   Regional Blood Flow Improvement by MRI (in Eligible Patients)   [ Time Frame: Measured at Baseline and Month 6 ]

6.  Secondary:   Regional Wall Motion by Echocardiography   [ Time Frame: Measured at Baseline and Month 6 ]

7.  Secondary:   Clinical Improvement in CCS Classification (Angina Pectoris)   [ Time Frame: Measured at Baseline and Month 6 ]

8.  Secondary:   Clinical Improvement in NYHA Classification   [ Time Frame: Measured at Baseline and Month 6 ]

9.  Secondary:   Number of Participants With a Decrease in Anti-anginal Medication   [ Time Frame: Measured at Baseline and Month 6 ]

10.  Secondary:   Exercise Time and Level   [ Time Frame: Measured at Baseline and Month 6 ]

11.  Secondary:   Serum BNP Levels in Patients With CHF   [ Time Frame: Measured at Baseline and Month 6 ]

12.  Secondary:   LV Diastolic Dimension   [ Time Frame: Measured at Baseline and Month 6 ]

13.  Secondary:   Incidence of a Major Adverse Cardiac Event   [ Time Frame: Measured at Baseline and Month 6 ]

14.  Secondary:   Reduction in Fixed Perfusion Defect(s)Via SPECT   [ Time Frame: Measured at Baseline and Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sample size was small and required large improvements in order to show significant treatment effects. SPECT often underestimates reversibility and viability in those with multivessel disease. Presence of cardiac devices limited MRI evaluation.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lemuel Moye, MD, PhD
Organization: UT-Houston School of Public Health
phone: 713-500-9518
e-mail: Lemmoye@msn.com


Publications of Results:
Other Publications:

Responsible Party: Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00824005     History of Changes
Other Study ID Numbers: 580, U01HL087318, 1 U01-HL-087318-01 (Project 3)
Study First Received: January 15, 2009
Results First Received: August 30, 2012
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration