ASTM initiated an extension study for control patients from the ongoing open-label Phase 2 IMPACT-DCM clinical trial in patients with dilated cardiomyopathy (DCM). The extension study is designed to offer control-group patients from the IMPACT-DCM trial the opportunity to receive treatment with an expanded mixture of their own bone marrow-derived stem and progenitor cells after completing at least 6 months of follow-up.
The initiation of this extension study follows a positive review of safety and efficacy data by the IMPACT-DCM data safety monitoring board (DSMB) for the first 20 patients who participated in the IMPACT-DCM trial. Independent approval of the amended protocol and initiation of the extension study has also been granted by all institutional review boards (IRBs) affiliated with the clinical study sites. Patient enrollment is expected this quarter.