Dive Brief:
- 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.
Dive Insight:
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.