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FDA Opens Door for Human Trial Medical Treatment from Embryonic Stem Cells

15 years, 2 months ago

8741  0
Posted on Jan 27, 2009, 3 p.m.

The Associated Press has reported that the Menlo Park-based biotech firm, Geron Corp (link) has been approved to conduct human trials (10 patients) for their stem-cell treatment for spinal cord injuries. This is the world's first study of a treatment using human embryonic stem cells. These trials come after more than 10 years of laboratory based progress at the firm according to the press coverage.

The Associated Press has reported that the Menlo Park-based biotech firm, Geron Corp (link) has been approved to conduct human trials (10 patients) for their stem-cell treatment for spinal cord injuries. This is the world's first study of a treatment using human embryonic stem cells. These trials come after more than 10 years of laboratory based progress at the firm according to the press coverage.

Though the approval of this trial is not directly related to the new Presidential Administration, it  is seen as a harbinger of a promised US policy shift on stem cell research. During his campaign, President Obama promised that he would make speedy progress in overturning research limitations.

Dr. Ronald Klatz, Founder and President of the American Academy of Anti-Aging Medicine said  in a recent interview with Worldhealth.net editors;"This is the mindset shift we have been waiting for. Stem Cell research will help pave the way to humans living longer.”

According to the Geron Corp president, Dr. Thomas Okarma, while the study's focus is on testing safety of the procedures, doctors do hope for signs of improvement in sensation and movement in the legs of the subjects.

“A lot of hope of the spinal cord injury community is riding on this trial,” said Dr. Wise Young, a spinal cord injury researcher at Rutgers University.

Dr. Mitchell Ghen, an internationally recognized lecturer and stem cell researcher commented, “It is said that a three thousand mile journey begins with the very first step.  This heralds the beginning of the United States' willingness to expand the potential of stem cell technologies. The American Academy for Anti-Aging Medicine has always presented stem cell technologies as an integral part of an anti-aging regenerative medicine program that could significantly extend the quality and quantity of human life.  A true goal of quality and longevity can only be obtained by the use of a stem cell transplant, along with individualized nutritional, detoxification and hormonal balancing programs. The 22,000 physician members of the A4M in over 100 countries, has been supporting this concept for over seven years and shall continue its philosophy of recognizing that conventional medicine must be met with reparative therapies.  These should include those that support the body's own innate healing capabilities along with stem cell introduction for regeneration of aged or damaged tissues and organs.”

His colleague, A4M Lecturer and Anti-Aging and Regenerative Medicine Diplomate, Mark Rosenberg, M.D. added, “This is truly an historic decision that will allow critical research to forge ahead.  Research has been ongoing now for years as scientists have tried to determine whether stem cells from adult tissues have the same capabilities and potential as embryonic stem cells.  Studies using embryonic stem cells have been slowed, however, by the ethical dilemma: extracting embryonic stem cells causes destruction of the embryo.  In addition, embryo destruction has essentially become entangled in the abortion debate, creating a mass of controversy.

Most adult stem cells are generally less flexible and versatile than embryonic stem cells. Embryonic stem cells have a far greater differentiation potential than adult stem cells simply because they can develop into almost every type of cell in the human body. Conversely, adult stem cells may only develop into a limited number of cell types, so their potential applications are not as great as embryonic stem cells.”

“Newer studies do, however, suggest that adult stem cells may have greater plasticity than was originally thought.  The research group headed by Catherine Verfaille in the Departments of Medicine, Microbiology, Neurosurgery and Genetics, Cell Biology and Development of the University of Minnesota Medical School, Minneapolis, discovered a rare kind of cells within the human bone marrow- the multipotent adult progenitor cells (mapcs) that can be expanded for more than 80 population doublings. The cells can be made to differentiate, at the single cell level, into bone and cartilage cells, skeletal muscle cells, fat cells, bone marrow stroma (ground substance) and endothelial cells (internal linings) of the internal organs.

Clearly, there are advantages and disadvantages to both adult stem cells and embryonic stem cells.  It may turn out that the two techniques will be used for different, rather than overlapping indications.  Putting the ethical debate aside, allowing the use of embryonic stem cells in clinical trials, in addition to adult stem cells, will allow medical science to make perhaps quantum leaps at a much faster pace.”

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