Aastrom Biosciences Inc, a leading developer of autologous adult stem cell treatments for severe chronic cardiovascular diseases, announced that the company has temporarily suspended enrolment and patient treatment in its US phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial.
The patient's cause of death has not yet been determined and is the subject of a pending investigation at the clinical site. An independent Data Safety Monitoring Board (DSMB) will also assess the circumstances of the event.
In accordance with standard operating procedures, the company has informed the US Food and Drug Administration (FDA) of the following: the death of the patient after being released from the hospital; the initiation of an investigation into the cause of death; and that the Company has voluntarily suspended patient enrolment and treatment in the trial. Subsequently, the FDA placed the trial on temporary clinical hold pending an investigation. Follow-up of patients previously enrolled in the IMPACT-DCM trial will continue in accordance with study protocol.
"Patient safety has been and continues to be our primary concern," stated Elmar R Burchardt, vice president, Medical Affairs at Aastrom. "We will continue to work closely with the trial site, the DSMB and the FDA to review the events surrounding the death of one of the patients in this clinical trial. We remain committed to ensuring patient safety and will work to resume patient enrolment and treatment in the IMPACT-DCM trial as soon as possible."
Upon completion of the investigation, Aastrom will work closely with the FDA to provide any information required in order to expedite its review and to resolve this matter so that patient enrolment into the IMPACT-DCM trial can resume as soon as possible. Aastrom will provide updated guidance regarding projected patient enrolment once the FDA has made its determination.
IMPACT-DCM is the first clinical trial in the US to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM) in both ischemic and non-ischemic patients. Patients randomized into the treatment group of the IMPACT-DCM trial are treated with Aastrom's Cardiac Repair Cells (CRCs), an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells produced from a small sample of the patient's own bone marrow.
DCM is a condition where enlargement of the patient's heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends upon the stage of the disease but is typically characterized by numerous health problems and a very high mortality rate.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue.