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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:
St. Luke's Medical Center
Aldagen
Information provided by (Responsible Party):
Emerson Perin, MD, PhD, Texas Heart Institute
ClinicalTrials.gov Identifier:
NCT00314366
First received: April 10, 2006
Last updated: April 22, 2014
Last verified: April 2014

April 10, 2006
April 22, 2014
April 2006
August 2009   (final data collection date for primary outcome measure)
Safety of aldehyde dehydrogenase bright stem cells versus the control group [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Safety of Aldehyde Dehydrogenous-Bright Stemcells versus the control group
Complete list of historical versions of study NCT00314366 on ClinicalTrials.gov Archive Site
Efficacy of aldehyde dehydrogenase bright stem cells in improving myocardial ischemia and consequently cardiac contractile function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Efficacy of Aldehyde Dehydrogenous-Bright Stemcells in improving myocardial
  • ischemia and consequently cardiac contractile function
Not Provided
Not Provided
 
Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)
Phase IB Randomized Controlled Double-Blind Trial of Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells Under Electromechanical Guidance for Therapeutic Angiogenesis

Recent studies have suggested that it may be possible to grow new blood vessels (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may stimulate the growth of new vessels. After a bone marrow procedure, the special cells are separated and then injected back into the heart around the area of damage with a special guidance and injection system.

Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be consented to the study and extensive baseline testing will be completed at St. Luke's Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has his/her own bone marrow harvested and later injected, if randomized to receive active treatment. The day after the bone marrow harvest, the patient is taken to the cardiac catheterization lab where NOGA mapping is performed and the processed cells or placebo are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow-up at weeks 1 and 4, and months 3 and 6, and at one year unless there is a crossover and then he/she begins baseline again at 6 months and follow-up for one more year. Follow-up testing, including quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.

This is a phase I, double blind trial to evaluate the use of Aldehyde Dehydrogenase-Bright (ALDHbr) in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous bone marrow cells in patients with end-stage ischemic heart disease is safe, can provide neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study is to assess the safety of the ALDHbr cell injections. The efficacy will be based upon treadmill MVO2. A maximum of 60 patients will be enrolled in the study. At the end of 6 months, after the required testing has been completed, the patients will be told whether they were in the control group or not. The patients in the control group will be given the option to crossover and actually receive stem cell injection. At the time of crossover, which then becomes the baseline, patients will begin the follow-up with all testing including clinic visits for one year for a total of 18 months follow-up.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
  • Biological: Stem Cell Therapy
    Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.
    Other Name: NOGA Myostar catheter
  • Other: 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.
  • Active Comparator: 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.
    Intervention: Biological: Stem Cell Therapy
  • Placebo Comparator: Plasma 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.
    Intervention: Other: Plasma control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
April 2021
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Canadian cardiovascular (CV) Class II-IV angina and/or congestive heart failure (CHF) symptoms
  • Ejection fraction less than or equal to 45%
  • Reversible perfusion defect on single photon emission computed tomography (SPECT)
  • Coronary artery disease (CAD) unable to be corrected by surgery (bypass) or intervention (stent)
  • Able to walk on treadmill
  • Hemodynamically stable

Exclusion Criteria:

  • Age less than 18 or greater than 70
  • Atrial fibrillation
  • Severe valve disease
  • History of cancer in last 5 years
  • HIV positive; hepatitis B or C positive.
  • Left ventricular wall thickness less than 8 mm
  • Recent heart attack within the last 30 days
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00314366
UT-H-GEN-05-0599
Yes
Emerson Perin, MD, PhD, Texas Heart Institute
Texas Heart Institute
  • St. Luke's Medical Center
  • Aldagen
Principal Investigator: Emerson Perin, MD, PhD Texas Heart Institute
Texas Heart Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP