- Two phase III trials -- ATHENA and ATHENA II -- are on clinical hold after a safety review revealed cerebrovascular events in the study subjects.
- The studies were designed to evaluate the use of adipose-derived regenerative cells (ADRCs) in heart-failure patients with ischemic heart disease.
- Cytori Therapeutics says it is determined to work with the FDA to make appropriate adjustments to the study protocol.
Although the safety report appeared damning on first glance, Cytori has responded that two of the three patients who experienced cerebrovascular events had fully recovered within a short period of time and the third patient had experienced a “substantial resolution of symptoms.”
Cytori is now working with a Data Monitoring Committee, along with trial investigators and external experts, to better understand what happened and adjust the trial parameters. The company's ultimate goal is to move forward -- safely.