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

Texas Heart Institute

Status and phase: Completed; Phase 1

Conditions: Coronary Artery Disease

Treatments: Other: Control (plasma); Biological: Stem Cell Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00314366

UT-H-GEN-05-0599

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

Stem Cell Therapy

Active Comparator group

Description:

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.

Treatment:

Biological: Stem Cell Therapy

Control

Placebo Comparator group

Description:

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. At 6 months, subject is offered stem cell therapy and then followed for 12 months.

Treatment:

Other: Control (plasma)