Sep. 27, 2000 PHILADELPHIA -- To test whether it will improve cardiac function, Temple University Hospital physicians have transplanted a patient’s own skeletal muscle cells (autologous myoblasts) directly into a damaged area of his heart.
Because heart muscle does not repair itself like skeletal muscle can, damage to the heart is permanent. The hope is that the transplanted skeletal muscle cells will help repair the damaged heart muscle and strengthen the patient’s heart contractions.
There are two goals of this Phase I trial: (1) to test the feasibility and safety of transplanting these cells into patients’ hearts and (2) to gain preliminary information on the cell’s survival and the potential for improvement of cardiac function that might be associated with the cell transplantation.
Dr. Howard Eisen, medical director of Temple’s heart transplantation program, and Dr. Satoshi Furukawa, surgical director of Temple’s heart transplantation program, are co-principal investigators of the trial. The trial is run in collaboration with and funded by Diacrin, Inc. (Nasdaq: DCRN)
A 48-year-old Norristown, Pa., resident was the first patient to receive the transplanted cells. After having a muscle biopsy taken from his arm, the biopsy was transported to Diacrin’s facility where the cells were isolated and expanded in culture. Approximately two weeks later, the cells were transplanted into the patient’s heart during surgery to implant a left ventricular assist device (LVAD). The patient is now on an LVAD waiting for a heart transplant.
All patients enrolled in this FDA-approved study will be candidates for heart transplantation and will be scheduled for placement of an LVAD as a bridge to the transplantation. The cells are transplanted into the heart at the time of the surgery to implant the LVAD.
Researchers will examine patients’ hearts after transplant to determine whether the skeletal cells survived and whether they helped repair the damaged heart.
Coronary heart disease is the leading cause of death in the United States, responsible for approximately one out of every five deaths, or approximately 500,000 deaths each year. The disease is caused by the accumulation of plaque on the walls of vessels supplying blood to the heart muscle. Rupture of unstable plaques promotes clot formation that can block one or more of the coronary vessels resulting in an inadequate supply of oxygen to the heart muscle. This highly active muscle is then quickly damaged and this damage cannot be repaired with available therapies.
Temple University Hospital is a 486-bed tertiary medical center located on Temple University’s Health Sciences Center campus in Philadelphia, Pa. Temple’s heart failure program is one of the largest in the country and recently celebrated the completion of its 800th heart transplant.
Diacrin, Inc., located in Charlestown, Mass., is developing transplantable cells for the treatment of human diseases which are characterized by cell dysfunction or cell death and for which current therapies are either inadequate or nonexistent. Additional products under development include: NeuroCell™-PD for Parkinson’s disease; porcine neural cells for stroke, focal epilepsy and intractable pain; porcine spinal cord cells for spinal cord injury; NeuroCell™-HD for Huntington’s disease; porcine liver cells for acute liver failure; human liver cells for cirrhosis; and porcine retinal pigment epithelial cells for macular degeneration. Diacrin is developing NeuroCell™-PD and NeuroCell™-HD in a joint venture with Genzyme Corporation.
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