Scimitar Equity Blog

In the area of heart disease, CYTX is sponsoring 2 EU clinical trials that evaluate the use of adipose-derived stem and regenerative cells (ADRCs) to treat acute myocardial infarction (heart attack) and chronic myocardial ischemia (a severe form of coronary artery disease).

Heart disease is the #1 cause of death in the US, EU and the majority of other countries around the world. Advanced heart disease accounts for many disabilities, lost productivity and diminished lifestyle. CYTX has performed pre-clinical (in the laboratory) studies that suggested a restoration of heart function following the application of adipose-derived stem and regenerative cells (ADRCs).

• APOLLO-01         Acute Myocardial Infarction (heart attack)
  Enrollment is complete with patient follow-up ongoing. The APOLLO-01 trial is a safety and feasibility study in the EU to evaluate the use of ADRCs as a treatment in heart attack patients. Within 24 hours of experiencing heart attack symptoms, a patient’s own ADRCs are extracted and injected into his/her coronary artery. The last patient enrolled in the study is expected to finish study participation by 4/12.  Meanwhile, primary outcome data from 6 months of study participation for all patients will be analyzed in 2010. This data will provide information on safety and feasibility of the use of ADRCs in this patient population,
• PRECISE-01           Chronic Myocardial Ischemia (coronary artery disease)
  Again, enrollment is complete with patient follow-up ongoing. The PRECISE-01 trial is a safety and feasibility study in the EU to evaluate the use of ADRCs in chronic ischemia patients that cannot be treated with other means. A patient’s own ADRCs are extracted and then injected around the injured, oxygen-deprived areas of his/her heart through a catheter. The last patient enrolled in the study is expected to finish study participation by 4/12.  Meanwhile, data from 6 months of study participation for all patients will be analyzed in 2010.  This data will provide information on safety and feasibility of the use of ADRCs in this patient population.

CYTX reports full, 6 month results from Apollo trial (heart attack) and preliminary, 6 month results from Precise (chronic ischemia) trial at Stem Cell Therapy and Cardiovascular Innovation conference. This Phase I data that has not been presented elsewhere. The data will also be out pre-market since CYTX is presenting the data from both of these studies on May 7 of this year at the Seventh International Symposium on Stem Cell Therapy and Cardiovascular Innovations in Madrid, Spain.

CYTX is also sponsoring an EU clinical study for patients requiring breast reconstruction after lumpectomy for breast cancer hoping to discover that enriching a patient’s fat graft with their (her) own adipose-derived stem and regenerative cells (ADRCs) to improve graft survival as well as patient and physician satisfaction.

There are limited reconstructive options to address tissue defects and asymmetry which commonly result from segmental mastectomy or quadrantectomy (lumpectomy). Breast implants do not adequately address these defects and other surgical options are traumatic and require prolonged hospitalization.    

• RESTORE-2          Transplantation of ADRC-Enriched Autologous  Fat Tissue
  Another EU study designed to evaluate the transplantation of ADRC-enriched autologous (patient’s own) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.  This data will provide information on safety, volume retention, and patient and physician satisfaction.