Cytori Therapeutics

RESTORE I was an independent Japanese study that examined reconstruction of partial mastectomy breast defects using ADRCs isolated using the Celution System. The 21 patient study was found to be safe and well tolerated in all patients. The study showed a high (79%) level of patient satisfaction with the final outcome.[4]

Following the promising results of RESTORE I, Cytori launched its own European breast reconstruction post-marketing study, named RESTORE 2, in June 2008. The 70 patient study was designed to assess patient and physician satisfaction, improvement in overall breast deformity, imaging, quality of life, and safety among other measures. The study completed enrollment in November 2009, with all patients to be followed up at both six and 12 months.

Six month interim results on 32 patients were presented at the 32nd Annual San Antonio Breast Cancer Symposium on December 12, 2009. In addition to reinforcing the safety of the procedure, the RESTORE 2 study showed that 73% of patients and 82% of physicians were satisfied with the outcome of the procedure.[5]

In addition to Celution, Cytori developed the Puregraft System which allows the physician to wash and purify the fat tissue before reinjection into the same patient, standardizing the fat graft preparation process.

Cytori received a 510(k) for market clearance of the Puregraft System in January 2010 for use in aesthetic body contouring using autologous fat grafts.[6] In addition to the Puregraft System, Cytori has developed the Celbrush, a precision fat graft delivery tool.

Cytori’s APOLLO study was designed to evaluate the use of ADRCs in the treatment of patients who have undergone myocardial infarctions. In March 2009, the study’s Steering Committee and the data safety and monitoring board (DSMB) deemed that the safety and feasibility goals of the study had been met after the enrollment of 14 patients. Primary outcomes for the study will be assessed at the six month follow up. The ADRC therapy resulted in a reduction in infarct size by 60%, and significant improvement of LV perfusion (MIBI SPECT) and an improvement of left ventricular function by 6% at 6 month followup. At 36 months FU, the improvement on infarct size persisted, as well as the effect LV function. A progressive improvement of cardiac remodelling was noted.

Cytori’s PRECISE study evaluates the use of ADRCs to treat patients suffering from chronic myocardial ischemia. Enrollment in the trial was completed in May 2009 with the enrollment of 27 patients. Primary outcomes of the study will be assessed at six months.

In addition to use in laboratory research, StemSource is the centerpiece of Cytori’s StemSource Cell Bank platform for cryopreservation and storage of a patients’ adult stem and regenerative cells (ADRC’s). The StemSource Cell Bank allows hospitals and companies to offer their patients the option of harvesting, preparation and storage of their adipose tissue or their processed ADRC’s.

Once the adipose tissue is extracted and prepared using the StemSource equipment, the storage technology freezes the tissue/cells at -196 degrees Celsius, which drastically slows the metabolism of the cells, preventing future aging or deterioration and preserving them for potential future use, should clinical applications be approved by governmental authorities.