SAN DIEGO & MINNEAPOLIS--(BUSINESS WIRE)--
Cytori Therapeutics (CYTX) announced the initiation of the FDA approved ATHENA clinical trial to investigate Cytoris cell therapy in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia. Cytoris cell therapy is based on a patients own adipose-derived stem and regenerative cells (ADRCs) processed by the Companys proprietary Celution System technology, making this the first FDA approved trial in the U.S. to evaluate ADRCs for cardiovascular disease. This first patient was treated by co-principal investigator Timothy Henry, M.D., Director of Research, at the Minneapolis Heart Institute Foundation in September and has undergone a seven day follow-up assessment. More details on the ATHENA trial may be found at http://www.theathenatrial.com.
Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available, said Dr. Henry. Cell therapy such as Cytoris has the potential to delay, halt, or even reverse this progression. We believe this is accomplished by the cells ability to promote angiogenesis and regulate the immune response to help revive damaged tissue that is alive yet not necessarily contributing to its fullest capacity toward the pumping ability of the heart.
ATHENA is a device-based, multi-center, prospective, randomized, double-blind PMA/IDE safety and feasibility (Phase I/II) trial that will enroll 45 patients in six centers in the U.S. Patients will be randomized to receive either Cytoris cell therapy (n=30) or an inactive placebo injection (n=15). All trial participants will undergo a minor liposuction procedure to remove adipose tissue. The adipose tissue will then be processed at the point-of-care with Cytoris proprietary system to separate and concentrate clinical-grade ADRCs. The treatment group will have a prescribed dose of the patients own ADRCs (0.4 million cells/kg body weight), which will then be injected into their damaged heart tissue using a minimally invasive catheter system.
Cytoris cell therapy has unique advantages compared to alternate cell sources such as bone marrow and peripheral blood, said Emerson Perin, M.D., Ph.D. of The Texas Heart Institute and co-principal investigator for ATHENA. Specifically, its a proprietary formulation that Cytori has optimized for vascular delivery and which contains an uncultured and mixed population of cells. As a result, this increases the number of cell types that potentially contribute to repair relative to a more homogenous population of cultured cells.
The trial will measure several endpoints, including peak oxygen consumption (VO2 Max). VO2 Max is an objective functional measurement that can be predictive of outcomes in heart disease, including mortality, and is commonly used as a primary determinant for qualifying patients for heart transplantation. Additional endpoints include perfusion defect, left ventricle end-systolic and diastolic volume and ejection fraction at six and 12 months. ATHENA will also evaluate medical economic factors such as rate of re-hospitalization and heart failure symptoms such as angina and quality of life at 12 months.
We believe Cytoris cell therapy will improve patient outcomes, said Marc H. Hedrick, M.D., president, Cytori Therapeutics. In ATHENA, investigators will be delivering a virtually off-the-shelf cell therapy comprised of a patients own cells, which is made possible by our technology. Using a patients own cells minimizes the risk of rejection or disease transmission compared to alternative therapies derived from donor cells and the virtually off-the-shelf nature allows the treatment to be accomplished in a single surgical procedure.
Cytori received approval from the FDA for its Investigational Device Exemption (IDE) application to begin ATHENA in January 2012 and the trial is currently expected to complete enrollment in mid-2013. In addition to Minneapolis Heart Institute Foundation, the Texas Heart Institute (Houston, TX) is actively screening patients under the direction of Emerson Perin, M.D., Ph.D., co-principal investigator for ATHENA, and James T. Willerson, M.D. Four additional centers are also expected to participate in the trial including:
Previously, Cytori reported six and 18-month safety and feasibility data from the PRECISE trial, a European clinical trial for this same indication. The PRECISE trial demonstrated a statistically significant improvement in VO2 Max in patients treated with Cytoris cell therapy compared to those treated with placebo. The Company is also conducting the ADVANCE trial, a European pivotal trial investigating the effect of Cytoris cell therapy in heart attack patients.
Refractory Heart Failure
Read this article:
First Patient Treated in Cytori’s U.S. Cell Therapy Heart Failure Trial
- Goodie Mob - Cell Therapy Instrumental [Last Updated On: April 2nd, 2011] [Originally Added On: April 2nd, 2011]
- Dogged by pain -- stem cell therapy for dogs [Last Updated On: April 3rd, 2011] [Originally Added On: April 3rd, 2011]
- SIRA: Could Stem Cell Therapy Renew Your Body Cells? – Affordable ... [Last Updated On: April 22nd, 2011] [Originally Added On: April 22nd, 2011]
- SIRA: Could Stem Cell Therapy Renew Your Body Cells? [Last Updated On: April 22nd, 2011] [Originally Added On: April 22nd, 2011]
- Stem Cell Therapy for Kidney Failure [Last Updated On: May 13th, 2011] [Originally Added On: May 13th, 2011]
- Dogs now getting stem cell therapy [Last Updated On: May 19th, 2011] [Originally Added On: May 19th, 2011]
- Goodie Mob - Cell Therapy Official Music Video (VJ CodyDietz.com ReMiX) [Last Updated On: May 20th, 2011] [Originally Added On: May 20th, 2011]
- Stem Cell Therapy for Autism [Last Updated On: May 20th, 2011] [Originally Added On: May 20th, 2011]
- Dog Undergoes Stem Cell Therapy [Last Updated On: May 20th, 2011] [Originally Added On: May 20th, 2011]
- Stem Cell Therapy for Cerebral Palsy [Last Updated On: May 22nd, 2011] [Originally Added On: May 22nd, 2011]
- Stem Cell Therapy for Type II Diabetes [Last Updated On: May 31st, 2011] [Originally Added On: May 31st, 2011]
- Stem Cell Therapy Success [Last Updated On: May 31st, 2011] [Originally Added On: May 31st, 2011]
- Heart Failure Patient After Adult Stem Cell Therapy [Last Updated On: June 1st, 2011] [Originally Added On: June 1st, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis [Last Updated On: June 3rd, 2011] [Originally Added On: June 3rd, 2011]
- Stem Cell Therapy for Critical Limb Ischemia [Last Updated On: June 12th, 2011] [Originally Added On: June 12th, 2011]
- Stem Cell Therapy Cream: Less Wrinkles In 30 Days or Less Anti-Wrinkle Cream That Works [Last Updated On: June 12th, 2011] [Originally Added On: June 12th, 2011]
- Stem Cell Therapy for Multiple Sclerosis [Last Updated On: June 13th, 2011] [Originally Added On: June 13th, 2011]
- Clinical Advances in Adult Stem Cell Therapy: Dr. Jorge Paz [Last Updated On: June 17th, 2011] [Originally Added On: June 17th, 2011]
- Stem Cell Injection Treatment - Stem Cell Therapy [Last Updated On: June 21st, 2011] [Originally Added On: June 21st, 2011]
- Stem Cell Therapy for Spinal Cord Injury - Injured Airline Pilot Flies Again [Last Updated On: July 1st, 2011] [Originally Added On: July 1st, 2011]
- Documentary: Stem Cell Therapy for Muscular Dystrophy - Ryan Benton's Story [Last Updated On: July 1st, 2011] [Originally Added On: July 1st, 2011]
- Documentary: Stem Cell Therapy for Muscular Dystrophy - Ryan Benton's Story [Last Updated On: July 1st, 2011] [Originally Added On: July 1st, 2011]
- XCell-Center Stem Cell Therapy Christmas Video 2010 [Last Updated On: July 2nd, 2011] [Originally Added On: July 2nd, 2011]
- Stem Cell Therapy for Stroke - Gary Steinberg, Stanford University [Last Updated On: July 9th, 2011] [Originally Added On: July 9th, 2011]
- Stem Cell Therapy Injections [Last Updated On: July 9th, 2011] [Originally Added On: July 9th, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl [Last Updated On: July 13th, 2011] [Originally Added On: July 13th, 2011]
- Adult Stem Cell Therapy Clinical Advances - Dr. Jorge Paz in San Diego, CA March 2011 [Last Updated On: July 14th, 2011] [Originally Added On: July 14th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Rationale [Last Updated On: July 15th, 2011] [Originally Added On: July 15th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Rationale [Last Updated On: July 15th, 2011] [Originally Added On: July 15th, 2011]
- Stem Cell Therapy--Hillcrest Animal Hospital [Last Updated On: July 18th, 2011] [Originally Added On: July 18th, 2011]
- Regenerative Medicine With Stem Cell Therapy Injections at an Arizona pain clinic (602) 507-6550 [Last Updated On: July 19th, 2011] [Originally Added On: July 19th, 2011]
- Bone Marrow Aspiration - Stem Cell Therapy [Last Updated On: July 19th, 2011] [Originally Added On: July 19th, 2011]
- The New World of Medicine: Stem Cell Therapy [Last Updated On: July 29th, 2011] [Originally Added On: July 29th, 2011]
- Post Stem Cell Therapy Video for Cerebral Palsy [Last Updated On: August 3rd, 2011] [Originally Added On: August 3rd, 2011]
- Lou Gehrig's Disease (ALS): Stem Cell Therapy - A Patient's Perspective [Last Updated On: August 5th, 2011] [Originally Added On: August 5th, 2011]
- Lou Gehrig's Disease (ALS): Stem Cell Therapy - A Patient's Perspective [Last Updated On: August 5th, 2011] [Originally Added On: August 5th, 2011]
- Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com [Last Updated On: August 9th, 2011] [Originally Added On: August 9th, 2011]
- WAVE3 News Adipose Stem Cell Therapy [Last Updated On: August 14th, 2011] [Originally Added On: August 14th, 2011]
- Embryonic stem cell therapy in China (www.esctherapy.com) [Last Updated On: August 17th, 2011] [Originally Added On: August 17th, 2011]
- Ying Liu discusses IPS cell therapy for ALS [Last Updated On: August 17th, 2011] [Originally Added On: August 17th, 2011]
- KO Clancy [Last Updated On: August 24th, 2011] [Originally Added On: August 24th, 2011]
- Stem cell therapy in Guatemala - (closer than China) [Last Updated On: August 26th, 2011] [Originally Added On: August 26th, 2011]
- ATP Cell Therapy [Last Updated On: August 27th, 2011] [Originally Added On: August 27th, 2011]
- Dr. Craig Saunders Adult Stem Cell Therapy [Last Updated On: August 28th, 2011] [Originally Added On: August 28th, 2011]
- Spinal Cord Injury - Stem Cell Therapy [Last Updated On: August 29th, 2011] [Originally Added On: August 29th, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia [Last Updated On: September 13th, 2011] [Originally Added On: September 13th, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia [Last Updated On: September 13th, 2011] [Originally Added On: September 13th, 2011]
- Stem Cell Therapy (Regenerative Medicine) in New Jersey [Last Updated On: September 17th, 2011] [Originally Added On: September 17th, 2011]
- Clinical Advances in Adult Stem Cell Therapy - Dr. Jorge Paz Rodriguez (Miami) [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Stem Cell Therapy Skin Repair and Anti-Wrinkle Cream [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- Cardiac Stem Cell Therapy [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
- Adult Stem Cell Therapy for Multiple Sclerosis [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
- SENS5 - Cellular Therapy for Intestinal Regeneration [Last Updated On: September 29th, 2011] [Originally Added On: September 29th, 2011]
- channel 10 news stem cell therapy for hair loss part 2.flv [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
- Multiple Sclerosis Stem Cell Therapy News Coverage [Last Updated On: October 4th, 2011] [Originally Added On: October 4th, 2011]
- Stem-Cell-Therapy-in-China.wmv [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- Adickes: Stem cell therapy [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- Don Reed: Why we need new stem cell therapies and how you can help [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- Repair Your Joint Injuries With Stem Cell Therapy | Los Angeles | Beverly Hills | Hollywood [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Repair Your Joint Injuries With Stem Cell Therapy | Los Angeles | Beverly Hills | Hollywood [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Ovation Cell Therapy Review (request) [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Glazer's Edge: Peyton's Stem Cells [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Glazer's Edge: Peyton's Stem Cells [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- The Spinal Cord Journey - Stem cell therapy stories from three spinal cord injury patients [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Goodie Mob - Cell Therapy - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- Randolph veterinarian uses new stem cell therapy on ailing pets - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- Stem Cell Therapy for Autism - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- 1 month after using Ovation Hair Cell Therapy and the results are...... - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- Stem Cell Series: Part 1 - Video [Last Updated On: October 15th, 2011] [Originally Added On: October 15th, 2011]
- Stem Cell Therapy for Multiple Sclerosis (MS patient) - Video [Last Updated On: October 15th, 2011] [Originally Added On: October 15th, 2011]
- Affordable Stem Cell Therapy in Guatemala (2hrs from Miami) - Video [Last Updated On: October 16th, 2011] [Originally Added On: October 16th, 2011]
- Duffy Update, Post Stem Cell Therapy - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- Duffy Gets Stem Cell Therapy - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- Adult Stem Cell Therapy for Congestive Heart Failure [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- CELL THERAPY - Video [Last Updated On: October 23rd, 2011] [Originally Added On: October 23rd, 2011]
- Stem Cell Therapy in Cardiac Disease - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - Community Outreach Dallas - Darnell Morris - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- UMBILICAL CORD STEM CELL THERAPY - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- Stem Cell Therapy for Multiple Sclerosis Stimulates IDO - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- Goodie Mob - Cell Therapy ( Killuminati Music ) - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]