Tag Archive for 'U.S. Food and Drug Administration'

PluristemBegins Enrollment in U.S. With Unmatched Placenta-Derived Stem Cell Product PLX-PAD in a Phase I Clinical Trial for Treatment of Peripheral Artery Disease

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Pluristem Therapeutics Inc. today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company`s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

Enrollment began at the Center for Therapeutic Angiogenesis in Birmingham, Ala., one of two clinical sites in the U.S. Duke University Medical Center will also be screening patients for the trial. The initiation of this study follows the approval of the Company`s Investigational New Drug (IND) application to begin clinical trials with PLX-PAD by the U.S. Food & Drug Administration (FDA). The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to 12 adults with the disease will be included in this dose escalating trial (…)

from http://www.reuters.com/article/pressRelease/idUS125367+10-Sep-2009+BW20090910

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Stem Cell Research Heals Heart Muscle After Heart Attack

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Another congestive heart failure patient has been helped by stem cell research using adult stem cells. Terry Areford, 62, a multiple heart attack victim has been given a 2nd chance at life after receiving Vescell stem cell treatment to heal his heart muscle in Thailand.

Congestive Heart Failure Symptoms

Terry was dying. He was slowing down. He had the usual symptoms of congestive heart failure. He had shortness of breath. He could barely walk 50 feet slowly. However, Terry still had hope. His daughter came across the Vescell website and contacted them.

Adult Stem Cells From Your Own Blood

For those of you unfamiliar with Vescell stem cell therapy in Thailand, it is a process created by a company called Theravitae in which adult stem cells are removed from the patient’s blood (similar to a blood donation) and then multiplied into a therapeutic dose and then implanted into the patient’s heart muscle and/or coronary arteries.

But back to Terry’s stem cell story-

Before Vescell Treatment

  • Ejection Fraction 10%
  • Could barely walk
  • Severe shortness of breath

After Adult Stem Cells Implanted

  • Ejection Fraction at 45%
  • Plays 3 rounds of golf per week
  • No shortness of breath- outside chopping firewood

3 full 18 hole rounds of golf per week? No kidding Terry?  I am very happy for you.   Like many of the Vescell heart patients recently, Terry has become an adult stem cell advocate and wants other congestive heart failure patients to know that there is still hope out there.

You are welcome to call or email Terry  at 304-594-9377 or his email is bkareford@msn.com

Stem Cell Research in Thailand

This is the third stem cell research success story to come out of Thailand in the last month. See stories from heart attack victims and heart failure patients James Eilert and Andy Jordan as well.   Is anyone in the FDA paying attention to this?  Adult Stem Cells can be used now to help these heart patients with no side effects!  Why do they have to leave the United States for it?

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Cardiac stem cell patient introduced

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Doctors with the University of Louisville and officials with Jewish Hospital Friday introduced the recipient of one of the world’s first adult cardiac stem cell infusion to treat congestive heart failure.

Michael Jones, 66, had his own cardiac stem cells injected directly into heart scar tissue, using a cardiac catheterization procedure, according to a news release.

Dr. Mark Slaughter, chief of the Division of Cardiothoracic Surgery at the University of Louisville and director of the Heart Transplant and Mechanical Assist Device Program at Jewish Hospital, performed coronary artery bypass surgery on Jones on March 23, according to the release.

Jones had congestive heart failure and permanent scarring of the heart resulting from multiple blocked arteries.
The cardiac stem cells injected into the scar tissue were removed from a portion of the upper chamber of Jones’ heart.

The tissue was sent to Harvard University and Brigham & Women’s Hospital in Boston, where the cardiac stem cells were grown.

The infusion was performed at Jewish Hospital by Dr. Sohail Ikram, a University of Louisville professor of medicine and director and chief of invasive and interventional cardiology at Jewish Hospital.

Leader of the study was Dr. Roberto Bolli, Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology and director of the University of Louisville’s Institute for Molecular Cardiology.
In the release, Bolli said the intent of the injection is to help the heart regenerate tissue and function.
The university and Jewish Hospital continue to enroll patients in the U.S. Food and Drug Administration-approved clinical trial.

from Business First

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