Stem Cell Research Breakthrough

The U.S. Food and Drug Administration’s recent approval of the first human clinical stem cell research trial represents a milestone of unlimited potential, especially in the treatment of cancer and spinal cord injuries.

The trial will be designed around embryonic human stem cells; this is considered a major breakthrough in the scientific community since the results are directly related to human beings.

Diseases from cancer to diabetes will be relevant and highly protractible. Geron Corp. of Menlo Park, CA, will conduct the first trials.

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure, and diabetes, according to the corporation’s website.

The company is advancing an anti-cancer drug and a cancer vaccine which target the enzyme telomerase through a multitude of clinical trials in different cancers.

President Obama in March 2009 signed an executive order that brought about major change in stem cell research. Obama lifted restrictions (imposed in 2001 by former President George W. Bush) on federal funding to help promote state-of-the art embryonic stem cell research.

“We will aim for America to lead the world in discoveries it may one day yield,’’ Obama said at that time.

Embryonic stem cells were first isolated and grown in a lab dish in 1998. That breakthrough stirred debate over ethics, morality and religious implications versus scientific and health benefits for mankind.

Proponents over the past decade have included former first lady Nancy Reagan and actors Michael J. Fox and the late Christopher Reeve, according to the Associated Press. Opponents object that human embryos have to be destroyed to harvest the cells.

Researchers remain intrigued and are still learning how the body uses stem cells to restore and regenerate human tissue. Doctors hope to restore and harness the power of these cells in efforts to have a human “repair kit.”

To that end, testing use of adult stem cells (typically taken from bone marrow and blood) is far ahead of embryonic, the AP's Malcolm Ritter reports.

Adult stem cells are being studied in people who suffer from multiple sclerosis, heart attacks and diabetes. Some early results suggest stem cells can help some patients avoid leg amputation. Recently, researchers reported that they restored vision to patients whose eyes were damaged by chemicals.

Transplants of adult stem cells have become a standard lifesaving therapy for perhaps hundreds of thousands of people with leukemia, lymphoma and other blood diseases, according to Ritter.

"That's really one of the great success stories of stem cell biology that gives us all hope," says Dr. David Scadden of Harvard, who notes stem cells are also used to grow skin grafts. "If we can recreate that success in other tissues, what can we possibly imagine for other people?"


The FDA originally approved the Geron study of embryonic human stem cells in January 2009 and it was scheduled to begin last summer. Plans for the trial came to an abrupt halt, however, when Geron scientists discovered animals in a preclinical study had developed a higher frequency (than normal) of cysts than had been observed in other studies, according to company officials.

Accordingly, the FDA put a hold on the trial. Since then, Geron claims to have developed new markers and assays for the therapy, and conducted another preclinical animal study.

Company officials, in a recent press release, say the purpose of the first phase of research in humans is to test the safety of the therapy in patients with spinal cord injuries. Candidates for the research study are those patients with the most severe cases.

Dr. Thomas Okarma, president and CEO of Geron Corp., told CNN that company scientists will be looking for any signs of recovery, in addition to verifying safety issues, in the Phase 1 trial.

If successful, Geron’s therapy – known as GRNOPC1 – also may have applications for Alzheimer’s disease, multiple sclerosis, and a fatal neurological disorder called Canavan disease.

Company officials say they cannot speculate on when the trial will begin, but they are optimistic that research work will launch this year, according to Geron spokeswoman Anna Krassowska.

The field of embryonic stem cells has been highly controversial for many years because the biomedical research process involves destroying the embryo which is four or five days old after removing the stem cells. At this point, the cells have a blank genetic predisposition and become any cell in the body by feeding it with genetic code.

We at WMB believe this research is monumental in understanding how genetics and genetic coding can influence cellular malfunction.

This work can be significant in our understanding of how to cure many diseases, especially as they relate to cancer, a leading cause of death.

This post is by TechMan, WMB co-author who blogs about trends, issues and ideas affecting business, industry, technology and consumers.