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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Biological: Stem Cell Therapy
Other: Plasma control
Phase 1

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
Official Title: Phase IB Randomized Controlled Double-Blind Trial of Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells Under Electromechanical Guidance for Therapeutic Angiogenesis

Resource links provided by NLM:


Further study details as provided by Texas Heart Institute:

Primary Outcome Measures:
  • Safety of aldehyde dehydrogenase bright stem cells versus the control group [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: April 2006
Estimated Study Completion Date: April 2021
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Stem Cell Therapy
Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.
Other Name: NOGA Myostar catheter
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00314366

Locations
United States, Texas
Texas Heart Institute/St. Luke's Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Texas Heart Institute
St. Luke's Medical Center
Aldagen
Investigators
Principal Investigator: Emerson Perin, MD, PhD Texas Heart Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Emerson Perin, MD, PhD, Director Clinical Research for Cardiovascular Medicine and Stem Cell Center, 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
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Heart Institute:
stem cell
autologous
ischemia

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

ClinicalTrials.gov processed this record on July 28, 2014