A Phase 2/3 interventional study of MyoCell and MyoCell in Congestive Heart Failure, sponsored by Bioheart, Inc.. Status unknown at 33 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Bioheart, Inc. · Phase 2/3, Interventional, and Treatment
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.
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 170 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Bioheart, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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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.
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Biological: MyoCell
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Biological: MyoCell
Patient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.
Procedure: Hypothermosol
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 million cells.
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.
6-minute walk test
Time frame: 6 months
Quality of Life Questionnaire
Time frame: 6 months
Hospitalization occurrences
Time frame: 12 months
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Bioheart, Inc.