Cytori Therapeutics has registered an investigational device exemption (IDE) application of its Celution System to initiate a clinical trial which is used to treat chronic myocardial ischemia (CMI).
The ATHENA trial is a device-based safety and feasibility trial (Phase I/II) which is designed to investigate the use of autologous, clinical-grade adipose tissue-derived stem and regenerative cells (ADRCs), processed at the point-of-care with Cytori’s proprietary Celution System.
Cytori said before the approval to begin the trial, it will submit Celution’s application to the US Food and Drug Administration (FDA) for review process.
Cytori reported Precise’s six and 18 month european trial clinical data which showed significant improvement in cardiac functional capacity, which was incorporated into the US IDE filing.
The company has also applied to expand its Celution System CE Mark to include no-option CMI claims in Europe based on this data.