FDA Removes Clinical Hold from Aastrom Phase II IMPACT-DCM Clinical Trial
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Aastrom Biosciences, Inc. has reported that the U.S. Food and Drug Administration (FDA) has removed the clinical hold from the Company's U.S. Phase II IMPACT-DCM clinical trial and that patient enrollment would resume at all five initiated clinical sites.
The IMPACT-DCM trial is evaluating the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient's own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.
On June 17, 2009, the FDA informed Aastrom that it had completed its investigation into the death of a patient following treatment with the Company's CRCs and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial could resume.
Based on autopsy results and medical records, the FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board (DSMB) have attributed the patient death to progression of the disease and determined it was unrelated to the CRC treatment.
"Patient safety is top priority for Aastrom. We are saddened by the loss of one of our patients. At the same time, we are grateful that this investigation was conducted in an efficient manner and that the FDA was able to provide prompt review and remove the clinical hold so quickly. This comprehensive review, along with the FDA's permission to carry on the trial without modifications, underscores the safety of the trial design and that our CRC product played no role in the patient's death," stated George W. Dunbar, President and Chief Executive Officer at Aastrom.
"We do not expect that this short delay will interfere with our goal of completing patient enrollment in this trial by the end of calendar year 2009. We are eager to resume patient enrollment and treatment in the IMPACT-DCM trial and to continue evaluating the clinical data we gather from these patients," Dunbar said.
To date, 14 of 40 patients have been enrolled in the IMPACT-DCM trial at the first three clinical sites: The Methodist DeBakey Heart & Vascular Center, Houston, TX, Baylor University Medical Center, Dallas, TX and The University of Utah School of Medicine, Salt Lake City, UT.
In addition, the fourth and fifth sites, Cleveland Clinic Heart & Vascular Institute in Cleveland, OH and Emory University Hospital Midtown in Atlanta, GA, were recently initiated and trained for participation in the IMPACT-DCM clinical trial.
"As unfortunate as this death is, it illustrates the severity of this disease and the need for a new therapeutic option for these patients who currently have limited alternatives other than a heart transplant or the implantation of a mechanical assist device," said Dr. Amit Patel, Associate Professor of Surgery at the University of Utah School of Medicine and the National Principal Investigator of the IMPACT-DCM clinical trial.
"At this time it is important to recall that the patients recruited into the IMPACT-DCM trial are in end-stage heart failure with ejection fractions below 30%. In contrast, many other comparable cardiac stem cell trials require an ejection fraction above this threshold. Therefore, we are only treating the most critically ill patients. The findings from the IMPACT-DCM trial could eventually have a significant impact on how congestive heart failure is treated in the future," he continued.
The IMPACT-DCM trial is evaluating the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient's own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.
On June 17, 2009, the FDA informed Aastrom that it had completed its investigation into the death of a patient following treatment with the Company's CRCs and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial could resume.
Based on autopsy results and medical records, the FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board (DSMB) have attributed the patient death to progression of the disease and determined it was unrelated to the CRC treatment.
"Patient safety is top priority for Aastrom. We are saddened by the loss of one of our patients. At the same time, we are grateful that this investigation was conducted in an efficient manner and that the FDA was able to provide prompt review and remove the clinical hold so quickly. This comprehensive review, along with the FDA's permission to carry on the trial without modifications, underscores the safety of the trial design and that our CRC product played no role in the patient's death," stated George W. Dunbar, President and Chief Executive Officer at Aastrom.
"We do not expect that this short delay will interfere with our goal of completing patient enrollment in this trial by the end of calendar year 2009. We are eager to resume patient enrollment and treatment in the IMPACT-DCM trial and to continue evaluating the clinical data we gather from these patients," Dunbar said.
To date, 14 of 40 patients have been enrolled in the IMPACT-DCM trial at the first three clinical sites: The Methodist DeBakey Heart & Vascular Center, Houston, TX, Baylor University Medical Center, Dallas, TX and The University of Utah School of Medicine, Salt Lake City, UT.
In addition, the fourth and fifth sites, Cleveland Clinic Heart & Vascular Institute in Cleveland, OH and Emory University Hospital Midtown in Atlanta, GA, were recently initiated and trained for participation in the IMPACT-DCM clinical trial.
"As unfortunate as this death is, it illustrates the severity of this disease and the need for a new therapeutic option for these patients who currently have limited alternatives other than a heart transplant or the implantation of a mechanical assist device," said Dr. Amit Patel, Associate Professor of Surgery at the University of Utah School of Medicine and the National Principal Investigator of the IMPACT-DCM clinical trial.
"At this time it is important to recall that the patients recruited into the IMPACT-DCM trial are in end-stage heart failure with ejection fractions below 30%. In contrast, many other comparable cardiac stem cell trials require an ejection fraction above this threshold. Therefore, we are only treating the most critically ill patients. The findings from the IMPACT-DCM trial could eventually have a significant impact on how congestive heart failure is treated in the future," he continued.
