The U.S. Government has given the go-ahead for the world’s first test in people of a therapy derived from human embryonic stem cells. The federal drug regulators have said that political considerations had no role in this decision. It did however coincide with the inauguration of President Obama who has pledged to remove the restrictions placed on the field by the previous administration.
The FDA approval comes a little more than 10 years after the first human embryonic stem cells were isolated at the University of Wisconsin. Because these cells can turn into any type of cell in the body, the theory is they may one day be able to provide tissues to replace worn-out organs or non-functioning cells to treat diabetes, heart attacks and other diseases. The field is known as regenerative medicine.
The clearance of the clinical trial is to be announced by the biotechnology company, Geron . The trial focuses on treating spinal cord injuries, which could help people suffering traumatic injuries from car accidents or motorcycle accidents. When Geron first applied to the Food and Drug Administration to conduct the trial last March their request was refused and more information was requested about the trial.
Stem cells derive from adults and fetuses have been used in some clinical trials, but they generally viewed as having less versatility than embryonic stem cells in terms of what tissue types they can form. The Bush administration had restricted federal financing for research on embryonic stem cells because creation of the cells entails the destruction of human embryos.
Geron’s therapy involves using various growth factors to turn embryonic stem cells into precursors of neural support cells, which are then injected into the spinal cord at the site of the injury. The hope is that the injected cells will help repair the insulation, known as myelin, around nerve cells, restoring the ability of some nerve cells to carry signals. There is also some hope that growth factors produced by the injected cells will spur damaged nerve cells to regenerate.
Even as some researchers have applauded the onset of clinical trials, others have expressed doubt as to whether or not the therapy would be unsafe. “It would be a disaster, a nightmare, if we ran into these kinds of problems in this very first trial,” said Dr. John A. Kessler, the chairman of neurology and director of the stem cell research at Northwestern University of Chicago and Evanston, Illinois.
Kreisman Law Offices has been handling medical malpractice lawsuits and Illinois personal injury cases in the Chicagoland area for over 30 years, serving such areas as Oak Park, River Forest, Cicero, and Lincolnwood.