Early Results From ADVANCE Trial Indicate Periprocedural Safety and Feasibility
SAN DIEGO, CA, USA I November 18, 2014 I Data was presented at the American Heart Association meeting in Chicago on November 17, 2014 regarding the safety and feasibility of Cytori Cell Therapy using Adipose Derived Regenerative Cells (ADRCs™) administered through the coronary artery in patients with acute ST segment elevated myocardial infarction from the ADVANCE clinical trial sponsored by Cytori Therapeutics, Inc. (NASDAQ: CYTX).
The ADVANCE clinical trial sought to define the safety, feasibility and efficacy of an intracoronary infusion of ADRCs in patients admitted with an acute ST-elevation myocardial infarction (STEMI) within 24 hours of successful primary percutaneous coronary intervention (PCI). In this randomized, double-blind, placebo-controlled trial (n=23, 2:1 randomization), within 24 hours of successful primary PCI following STEMI, a small volume liposuction was performed for fat harvest and ADRC isolation by an automated cell processing system (Celution® System), and intracoronary infusion within 12 hours of the liposuction.
STEMI patients were routinely treated with dual antiplatelets and heparin. The decline in hemoglobin following the liposuction procedure from baseline over the 10 hours following the procedure was approximately 10%. The liposuction procedure was completed in all but one patient (stopped due to hypotension, which resolved with termination of procedure). Intracoronary infusion of the ADRC suspension was performed successfully in all patients. No impediment of coronary TIMI flow was observed during or following cell infusion of these mesenchymal-like cells. No ventricular arrhythmias were observed during cell infusion. No major adverse cardiac or cerebral events occurred within 30 days of the procedures.
“Although conclusions from the study are limited by the relatively small sample size, it appeared that small volume fat harvest for ADRC preparation and subsequent intracoronary infusion is feasible and can be performed with an acceptable safety profile in patients with acute STEMI under dual antiplatelet therapy,” said Dr. Steven Kesten, Chief Medical Officer. “This finding is consistent with that found in the previously reported APOLLO trial. Data collection of the one year outcomes has been completed and will be discussed in a future meeting or communication.”
About Cytori Therapeutics, Inc.
Cytori Therapeutics, Inc. is developing cell therapies based on autologous ADRCs to treat cardiovascular disease, orthopedic disorders, complications of immunologic disease, urinary incontinence and thermal burns combined with radiation injury. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® system product family. For more information visit www.cytori.com.
SOURCE: Cytori Therapeutics
Post Views: 265
Early Results From ADVANCE Trial Indicate Periprocedural Safety and Feasibility
SAN DIEGO, CA, USA I November 18, 2014 I Data was presented at the American Heart Association meeting in Chicago on November 17, 2014 regarding the safety and feasibility of Cytori Cell Therapy using Adipose Derived Regenerative Cells (ADRCs™) administered through the coronary artery in patients with acute ST segment elevated myocardial infarction from the ADVANCE clinical trial sponsored by Cytori Therapeutics, Inc. (NASDAQ: CYTX).
The ADVANCE clinical trial sought to define the safety, feasibility and efficacy of an intracoronary infusion of ADRCs in patients admitted with an acute ST-elevation myocardial infarction (STEMI) within 24 hours of successful primary percutaneous coronary intervention (PCI). In this randomized, double-blind, placebo-controlled trial (n=23, 2:1 randomization), within 24 hours of successful primary PCI following STEMI, a small volume liposuction was performed for fat harvest and ADRC isolation by an automated cell processing system (Celution® System), and intracoronary infusion within 12 hours of the liposuction.
STEMI patients were routinely treated with dual antiplatelets and heparin. The decline in hemoglobin following the liposuction procedure from baseline over the 10 hours following the procedure was approximately 10%. The liposuction procedure was completed in all but one patient (stopped due to hypotension, which resolved with termination of procedure). Intracoronary infusion of the ADRC suspension was performed successfully in all patients. No impediment of coronary TIMI flow was observed during or following cell infusion of these mesenchymal-like cells. No ventricular arrhythmias were observed during cell infusion. No major adverse cardiac or cerebral events occurred within 30 days of the procedures.
“Although conclusions from the study are limited by the relatively small sample size, it appeared that small volume fat harvest for ADRC preparation and subsequent intracoronary infusion is feasible and can be performed with an acceptable safety profile in patients with acute STEMI under dual antiplatelet therapy,” said Dr. Steven Kesten, Chief Medical Officer. “This finding is consistent with that found in the previously reported APOLLO trial. Data collection of the one year outcomes has been completed and will be discussed in a future meeting or communication.”
About Cytori Therapeutics, Inc.
Cytori Therapeutics, Inc. is developing cell therapies based on autologous ADRCs to treat cardiovascular disease, orthopedic disorders, complications of immunologic disease, urinary incontinence and thermal burns combined with radiation injury. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® system product family. For more information visit www.cytori.com.
SOURCE: Cytori Therapeutics
Post Views: 265
