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

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. 

Mitchell Ghen, D.O., Ph.D., 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 Diplomate in Anti-Aging and Regenerative Medicine, 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."