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Sponsored by: |
Bioheart, Inc. |
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Information provided by: | Bioheart, Inc. |
ClinicalTrials.gov Identifier: | NCT00526253 |
This study injects a person's own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patient's heart performance.
Condition | Intervention | Phase |
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Congestive Heart Failure |
Biological: MyoCell Procedure: Hypothermosol |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s) |
Estimated Enrollment: | 390 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Low Dose: Active Comparator
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
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Biological: MyoCell
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.
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High Dose: Active Comparator
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
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Biological: MyoCell
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 million cells.
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Control: Placebo Comparator
Patient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.
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Procedure: Hypothermosol
After the cell culture period of time has passed, patient's myocardium will be injected with the transport media alone. Patient will not receive any cultured myoblasts during these injections.
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Autologous myoblasts are harvested from a patient's skeletal muscle tissue. The myoblasts are isolated and expanded in culture in a closed system. When a sufficient number of cells are estimated they are taken from culture, packaged in a suspension and sent to the patient's interventionalist. The interventionalist uses an injection catheter via femoral artery to inject the myoblasts directly into the myocardium.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible patients must meet ALL of the following inclusion criteria during the screening/enrollment visit #1 and prior to being randomized into the study. Screening/enrollment visit #1 is defined to start the date the ICF is signed by the patient:
Stable and on optimal medical management for greater or equal to 60 days as follows:
Exclusion Criteria:
Inability to perform a 6 minute walk test due to physical limitations other than HF including:
30 Unwilling and/or not able to give written informed consent.
Contact: Doug Owens, RN, MPH, CCRA | 954-835-1500 | dowens@bioheartinc.com |
Responsible Party: | Center for Interventional Vascular Therapy ( Warren Sherman, MN ) |
Study ID Numbers: | BMI-WW-02-003 |
Study First Received: | September 6, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00526253 |
Health Authority: | United States: Food and Drug Administration |
Congestive Heart Failure CHF Heart Disease Heart Attack |
Stem Cell Myoblast Bioheart |
Necrosis Heart Failure Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |