Phase III Trial uses Autologous Cells for Angina

Baxter Tuesday started a phase III pivotal clinical trialto evaluate the efficacy and safety of an individual’s own CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI), a coronary artery disease. CMI is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions. Cell therapy is typically more expensive, requiring thousands of dollars to manufacture an individual cell therapy. Baxter has announced 450 patients for its trial. It may take…

Texas Adopts Controversial Stem Cell Rules

Texas Medical Board Approves Adult Stem Cell Guidelines The Texas Medical Board has approved guidelines for the use of adult stem cells. The new rules say that the procedure must be part of a clinical trial and have the approval of the Food and Drug Administration or an institutional review board. Leigh Hopper, a spokesperson for the Texas Medical Board says these institutions will make sure the use of adult stem cells is safe, ethical and that patients give informed consent. Hopper says board members felt that since patients already have access to adult stem cells, the procedure needs to be regulated. “Since this is occurring right now, the majority of the board felt that…

Experts Divided on Texas Stem Cell Treatment Regulation

Concerns Draft Rule’s Requirements for IRB Review are “weak”  Tomorrow the Texas Medical Board will decide whether to sign off on what’s said to be the first state-level policy imposing oversight on the medical use of experimental treatments using adult stem cells. The hotly debated plan has drawn mixed views from the scientific community over whether it’s a good way to raise standards—and has generated confusion in the media. Some experts say the rule will allow unscrupulous doctors to evade review by the Food and Drug Administration (FDA) because it may clear methods that haven’t been rigorously examined. But others say the rule, while imperfect, is a good-faith effort to bring oversight to these controversial,…

NIH Renews Support to 7 Sites Nationwide

From bench to bedside: NIH grant establishes cardiac clinical research center at UofL University of Louisville among 7 sites nationwide for Cardiac Cell Therapy Research Network To paraphrase Yogi Berra: It’s déjà vu all over again – with a twist. A University of Louisville researcher known for his prowess at winning competitive grants from the National Institutes of Health has won another one – his first for clinical research. During his 18-year tenure at UofL, Dr. Roberto Bolli has generated more than $100 million in grants for basic research from the NIH. Today, Bolli joined with University of Louisville President James R. Ramsey to announce a new NIH grant he has won for clinical research,…

Knowledge gained paves way for future of cell therapy

  Stem cell, heart heath study Stem cells from someone’s bone marrow could help repair heart damage Doctors from the Texas Heart Institute at St. Luke’s Episcopal Hospital have found that patients with heart failure may be able to repair the damaged areas of the heart with stem cells from the patient’s own bone marrow. Doctors presented the findings at the American College of Cardiology’s 61st Annual Scientific Session Saturday. The results are from a multi-center clinical study that measured the possible benefits of using a patient’s own bone marrow cells to repair damaged areas of the heart suffering from severe heart failure, a condition that affects millions of Americans.     The study, which…

Stem cells from fat win favor with heart researcher

(Reuters) – Stem cells derived from a patient’s bone marrow can help treat severe heart failure, but the results are even better when they are taken from fat, a leading researcher said, citing his experience in a number of studies. “It’s no longer a question whether the bone marrow cells work or don’t work; they do work when you have healthy stem cells,” Dr. James Willerson of the Texas Heart Institute said in an interview. “The search now is to find the very best stem cell type or types. “And at the moment, I’d say the best stem cells are fat-derived cells and stem cells that reside in the heart called c-KIT positive stem cells,”…

Positive Data from Heart Failure Clinical Trial

A leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that positive data from a Phase 1 clinical trial of ALD-201 to treat ischemic heart failure were published in the March 2012 online edition of the American Heart Journal. In the study, ALD-201 was considered safe and demonstrated initial evidence of improved blood flow and improved clinical status. ALD-201 is a population of biologically instructive adult stem cells (aldehyde dehydrogenase bright cells, or ALDHbr that are selected from the patient’s own bone marrow using the ALDH enzyme as a marker.  Read More The article is entitled, “Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase–bright stem cells…

Regeneration Scientist Returning to Texas- Interveiw

Renowned cardiac regeneration scientist Doris Taylor departs the University of Minnesota for the Texas Heart Institute.  Dr. Taylor looks forward to taking ideas that are being developed in laboratories and moving them into clinical trials. Listen to interview with Carrie Miller, Minnesota Public Radio MPR News March 7th, 2012   Recommend on FacebookTell a friend

Stem cells for cardiac repair; an active area of research

A two-part Series published in Lancet gives insight into the use of stem cells in the new discipline of regenerative medicine. Stem cells are widely researched for their therapeutic use. An important potential application of human stem cells, through a more complete understanding of the genetic and molecular controls of cell division and differentiation, is the generation of cells and tissues that could be used for cell-based therapies. The use of embryonic and adult-derived stem cells for cardiac repair is a particularly active area of research. The first Series paper highlights insights gained from clinical trials of adult stem cells, together with fundamental scientific advances in cardiac stem cell and regenerative biology. New targets and…

Genetic manipulation boosts growth of brain cells

Genetic manipulation boosts growth of brain cells linked to learning, enhances antidepressants UT Southwestern Medical Center investigators have identified a genetic manipulation that increases the development of neurons in the brain during aging and enhances the effect of antidepressant drugs. The research finds that deleting the Nf1 gene in mice results in long-lasting improvements in neurogenesis, which in turn makes those in the test group more sensitive to the effects of antidepressants. “The significant implication of this work is that enhancing neurogenesis sensitizes mice to antidepressants – meaning they needed lower doses of the drugs to affect ‘mood’ – and also appears to have anti-depressive and anti-anxiety effects of its own that continue over time,”…

Investigational Human Stem Cell Therapy Study

Investigational Human Adult Stem Cell Therapy Studied in Ischemic Stroke Patients Physicians at the Methodist Neurological Institute are studying the use of human stem cells as a possible treatment for acute ischemic stroke, a leading cause of death and disability. Each year, stroke affects more than 15 million people around the world. Patients whose ischemic strokes occur within one to two days of being admitted to The Methodist Hospital in Houston may be eligible to enroll in the double-blind, randomized, placebo-controlled phase 2 safety and efficacy trial of MultiStem®, a novel therapy being developed by Athersys, Inc. “The thrombolytic tPA is still the only FDA-approved treatment for the majority of stroke cases, but unfortunately, we…

Charitable donation the second largest in Children’s history

UT Southwestern, Children’s Partner for New Stem Cell, Cancer Institute Curing cancer is a lofty goal. But that is the talk among people involved in a new joint venture between the University of Texas Southwestern Medical Center and Children’s Medical Center. Officials with both hospitals are set to announce a $150 million stem cell and cancer research institute, set to open on the UT Southwestern campus. The money includes a $10 million gift, the second-largest in Children’s history, from the Hamon Charitable Foundation. Dr. Sean Morrison, of UT Southwestern, will lead the Hamon Laboratory for Stem Cell and Cancer Biology. According to his supervisors, Morrison’s laboratory works at the interface of stem cell biology and…

UTSW Molecular Biologist wins Passano Award

DALLAS – March 6, 2012 – Dr. Eric Olson, founding chairman of the molecular biology department at UT Southwestern Medical Center, has won the 2012 Passano Award for identifying major genetic pathways that control the development of the heart and other muscles. In announcing the award, Passano Foundation officials noted that Dr. Olson’s discoveries at the interface of developmental biology and medicine “have profoundly influenced our understanding of the mechanisms responsible for development and dysfunction of the heart.” His laboratory has used a sophisticated combination of biochemistry and genetics to expose networks of genes that control the formation of the heart and cardiovascular system. In so doing, Dr. Olson “unveiled the molecular underpinnings of congenital…

Phase III autologous cell therapy trial for angina

Baxter Tuesday started a phase III pivotal clinical trial to evaluate the efficacy and safety of an individual’s own CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI), a coronary artery disease. CMI is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions. Cell therapy is typically more expensive, requiring thousands of dollars to manufacture an individual cell therapy. Baxter has announced 450 patients for its trial. It may take the…

Texas Medical Board Moves to Regulate Adult Stem Cell Use

 AUSTIN – The Texas Medical Board Friday approved a tentative policy regulating the use of adult stem cells, the experimental therapy Gov. Rick Perry drew criticism for undergoing for his ailing back last year. “This policy will afford the public protection that doesn’t exist now for products not approved by the Food and Drug Administration,” said Dr. Irwin Zeitler, president of the board. “At the same time, it doesn’t hinder progress. Hundreds of studies have shown the promise of adult stem cells.” Under a policy that will come up for final approval April 13, Texas doctors would be authorized to provide stem cell therapy only if an independent review committee that assesses research trials for patient safety grants permission. The…

Heart Stop Beating Premiers at Sundance

Two Houston surgeons have successfully implanted the world’s first continuous-flow artificial heart in a human patient, a significant advance that promises a smaller and much more durable alternative to existing artificial hearts. Drs. Bud Frazier and Billy Cohn took out the dead heart of 55-year-old Craig A. Lewis on March 10 at the Texas Heart Institute. After harmful proteins built up in his heart to the point it could no longer work, Lewis lived only with the aid of external breathing, dialysis and heart support machines. The Houston man had maybe a day to live when Frazier and Cohn were given the opportunity to test their device — a pair of turbines cobbled together to…

Leading the Texans’ Fight Against Heart Disease

James T. Willerson describes himself as a proud Texan. He was born in the small town of Lampasas, grew up in San Antonio, studied in Austin, and has spent the majority of his medical career in Dallas and Houston—save for five years training in Boston and two at the National Institutes of Health, Bethesda, MD. Despite his strong attachment to the Lone Star State, however, his contribution to cardiovascular science is world-renowned. Indeed, in addition to his long list of U.S. honors, which include membership of the Institute of Medicine of the National Academy of Sciences, a Distinguished Scientist Award from the American College of Cardiology, and both Distinguished Scientist and Gold Heart Awards from…

The Cell Society to meet in San Diego

The Cell Society is holding their 2nd Annual Meeting in San Diego February 17th and 18th. Cell Society’s Annual Clinical Meeting will continue in the tradition established at the 1stAnnual Meeting and will offer a unique opportunity for multidisciplinary, international clinical collaboration designed to enhance understanding and thought provoking insight into treatments and cures for disease and agonizing medical conditions. This year’s clinical focus will center on therapies particularly relevant to cardiology, neurology, orthopedic and plastic surgery. A full 73% of their 2012 conference program will be dedicated to evidence-based, accredited clinical discussion.  The remainder will feature industry updates and relevant regulatory discourse and debate. The Cell Society firmly believes that cell therapies can enhance current…

Collaborating to Advance Medical Research Needs

Texans For Stem Cell Research (TSCR), a non-partisan, non-profit 501(c)3 volunteer organization dedicated to the advancement of stem cell clinical applications for the treatment of disease and debilitating injury, and the CORE Health Foundation, a non-profit disability advocacy organization that facilitates brain injury research, announced their collaboration for a Feb. 3 Learn for Life event that will examine early results of a stem cell therapy clinical trial for acute stroke patients and discuss the potential of a stem cell research facility in the proposed medical school to be located in Austin, Texas. The Learn for Life event, “A Night with Dr. Sean I. Savitz,” will feature the renowned neuroscientist’s presentation on “Emerging Treatment of Stem…

New Children’s Research Institute at UTSW Breakthrough

Scientists with the new Children’s Research Institute at UT Southwestern Medical Center have identified the environment in which blood-forming stem cells survive and thrive within the body, an important step toward increasing the safety and effectiveness of bone-marrow transplantation. Institute investigators led by Dr. Sean Morrison asked which cells are responsible for the microenvironment that nurtures haematopoietic stem cells, which produce billions of new blood cells every day. The answer: endothelial and perivascular cells, which line blood vessels. “Although scientists have searched for decades to identify the stem cell home, this is the first study to reveal the cells that are functionally responsible for the maintenance of  blood-forming stem cells in the body,” said Dr….