Myocell SDF-1
Our MyoCell SDF-1 product candidate, which has recently received approval from the FDA to begin human clinical trials, is intended to be an improvement to MyoCell. Bioheart worked with the Cleveland Clinic and the University of Florida to develop the MyoCell SDF-1 technology. In addition, in connection with our establishment of the relationship with the Cleveland Clinic, Dr. Marc Penn, the Medical Director of the Cardiac Intensive Care Unit at the Cleveland Clinic and a staff cardiologist in the Departments of Cardiovascular Medicine and Cell Biology, joined our Scientific Advisory Board.
We anticipate that MyoCell SDF-1 will be similar to MyoCell, except that the myoblast cells to be injected will be gene-modified prior to injection by an adenovirus vector or a non-viral vector so that they will release extra quantities of the SDF-1 protein. Following injury which results in inadequate blood flow to the heart, such as a heart attack, the human body naturally increases the level of SDF-1 protein in the heart. By modifying the myoblasts to express SDF-1 prior to injection, we are seeking to increase the SDF-1 protein levels present in the heart. We are seeking to demonstrate that the presence of additional quantities of SDF-1 protein released by the myoblasts will stimulate the recruitment of the patient's existing stem cells to the cell transplanted area and, thereafter, the recruited stem cells will assist in the tissue repair and blood vessel formation process. Preclinical animal studies demonstrated a definite improvement of cardiac function when the myoblasts were modified to express the SDF-1 protein as compared to the injection of unmodified myoblasts.
We received IND approval from the FDA for Phase I clinical trials of MyoCell SDF-1 in July 2009.
Candidate |
Proposed Use or Indication |
Status/Phase |
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|---|---|---|---|---|
| MyoCell® SDF-1 | Autologous cell therapy treatment for severe chronic damage in the heart; cells modified to express angiogenic proteins. | IND application approved July 2009 |