Another Milestone, Aastrom Biosciences (NASDAQ: ASTMD)
ASTMD reported the final patient treatment in the ongoing cardiac regeneration US P 2 surgical clinical trial designated IMPACT-DCM. Treated at Emory University Hospital Midtown in Atlanta, GA, this patient received direct injections of ASTMD’s tissue repair cells for the treatment of dilated cardiomyopathy (DCM), a severe form of congestive heart failure in which the heart becomes weakened and enlarged and cannot pump blood efficiently.
- With the treatment of the final patient in this trial, Aastrom is positioned to report 6 month interim data on all enrolled patients in late 2010.
IMPACT-DCM is a randomized, controlled, open-label P 2 trial which targeted enrollment of 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at 5 clinical sites in the US. Control patients receive standard medical care, while patients in the treatment arm have received injections of ASTMD’s tissue repair cells directly into the wall of the left ventricle in addition to standard medical care.
- While the primary objective of this trial is to assess safety in patients with DCM, efficacy measures including cardiac dimensions, heart failure stage and other measures of cardiac function are being monitored,
- Patients are being evaluated at both 6 months and 12 months following treatment,
- 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 DCM in both ischemic and non-ischemic patients,
- This is also the first US P 2 cellular therapy trial for heart failure to complete enrollment.
