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Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CHI St. Luke's Health, Texas
Aldagen
Information provided by (Responsible Party):
Emerson Perin, MD, PhD, Texas Heart Institute
ClinicalTrials.gov Identifier:
NCT00314366
First received: April 10, 2006
Last updated: October 17, 2016
Last verified: October 2016
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Biological: Stem Cell Therapy
Other: Control (plasma)

  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
Twenty one patients were recruited between 9/1/06 and 8/6/08 from outpatient Cardiology clinics.

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
Stem Cell Therapy

Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.

Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.

Control

Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.

Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.


Participant Flow:   Overall Study
    Stem Cell Therapy   Control
STARTED   11   10 
COMPLETED   10   10 
NOT COMPLETED   1   0 
not treated due to patient medical condi                1                0 



  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
Stem Cell Therapy

Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.

Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.

Control

Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.

Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.

Total Total of all reporting groups

Baseline Measures
   Stem Cell Therapy   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   10   20 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age   58.2  (6.1)   57.8  (5.5)   58.0  (5.8) 
Gender 
[Units: Participants]
     
Female   1   2   3 
Male   9   8   17 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures
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1.  Primary:   Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   New York Heart Association (NYHA) Classification   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Canadian Cardiovascular (CCS) Angina Score   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Echocardiography (EF)Percent (%)   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Left Ventricular End-Systolic Volume (LVESV) (ml)   [ Time Frame: baseline and 6 months ]

6.  Secondary:   Left Ventricular End-Diastolic Volume (LVEDV)   [ Time Frame: baseline and 6 months ]

7.  Secondary:   Echocardiography Wall Motion Score Index (WMSI)   [ Time Frame: baseline and 6 months ]

8.  Secondary:   Myocardial Oxygen Consumption (MVO2)   [ Time Frame: baseline and 6 months ]

9.  Secondary:   Echocardiography (EF) Percent (%)   [ Time Frame: baseline and 6 months ]

10.  Secondary:   Total Severity Score (Stress)   [ Time Frame: baseline and 6 months ]

11.  Secondary:   Total Severity Score (Rest)   [ Time Frame: baseline and 6 months ]

12.  Secondary:   Total Severity Score (Reversible)   [ Time Frame: baseline and 6 months ]


  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
The study is a preliminary study based on a small sample size which limits the statistical rigor of the analysis.


  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: Emerson C. Perin, M.D., Ph.D.
Organization: Texas Heart Institute
phone: 832-355-9405
e-mail: eperin@texasheart.org


Publications:

Responsible Party: Emerson Perin, MD, PhD, Texas Heart Institute
ClinicalTrials.gov Identifier: NCT00314366     History of Changes
Other Study ID Numbers: UT-H-GEN-05-0599
Study First Received: April 10, 2006
Results First Received: June 5, 2015
Last Updated: October 17, 2016
Health Authority: United States: Food and Drug Administration