Aastrom Biosciences (ASTM), IMPACT-DCM Clinical Results presented
US Phase 2 IMPACT-DCM clinical trial results were reviewed at The Sixth International Conference on Cell Therapy for Cardiovascular Disease in NYC, NY, by Amit N. Patel, MD, MS, associate Professor of Surgery at the University of Utah School of Medicine and national principal investigator.
Dr. Patel presented 6 month interim results from the Phase 2 IMPACT-DCM clinical trial for surgical administration of expanded autologous mixed-cell therapy in patients with dilated cardiomyopathy (DCM).
- Previously reported results indicate that treatment is safe and showing that adverse events were minor and associated only with the surgical procedure;
- No AEs were reported associated with the therapy and AEs were similar in the treatment and control groups;
- Reviewed findings showed consistent and positive trends in quality of life, functional and structural parameters in the treatment group.
ASTM expects to report 12-month data from the IMPACT-DCM clinical study in Q2/11 and 6 month results from the DCM catheter Phase 2 clinical study in Q3/11.