Embryonic Stem Cell Trial Not Designed to Help Patients

Bioethics   |   Rebecca Taylor   |   Jul 15, 2011   |   3:24PM   |   Washington, DC

Last year the FDA gave Geron approval to begin trials with cells derived from embryonic stem cells on patients with recent spinal cord injury. Now the second trial with embryonic stem cell derivatives has begun.  This time two women with different kinds of macular degeneration have been injected with these cells in what is being called a trial to “treat” eye disease.  From the LA Times:

Stem cell clinical trials to treat eye diseases begin at UCLA

After more than 20 years of research, doctors at UCLA’s Jules Stein Eye Institute have begun treating the first patients in clinical trials for two progressive eye diseases that cause blindness: dry age-related macular degeration and Stargardt’s macular dystrophy.

The patients were given an injection of specialized eye cells that were derived from embryonic stem cells. Dr. Steven Schwartz, who is leading the trial at UCLA, performed both stem cell transplant surgeries Tuesday. The two patients are said to be recovering without complications.

Reading no further one might think that this trial is to cure these women of their eye disease.  It is not.  This is a Phase I trial which means it is for safety reasons only.  In fact, this particular trial is not designed to “treat” any blindness:

Will the patients regain vision?

The patients’ central vision is already gone. Not rescuable. So the patients we’re enrolling in this trial know they will not be getting their central vision back.

If not to restore vision, what is the goal?

This is a safety trial. It’s not designed to improve vision.

Safety is a real issue with embryonic stem cells because they are widely known to cause tumors in animal models.  So these women are volunteering for a very risky trial with no intended benefit to themselves.  Dr. Suzanne Ildstad, a researcher who is working toward using a patient’s own adult stem cells to treat eye-related disorders, is concerned about the safety of using embryonic stem cells.  From an article in 2009 on the use of adult stem cells to treat macular degeneration:

Ildstad says there is growing concern in the use of embryonic stem cells. “There’s been a real problem with cancer formation. I just reviewed a paper that was using embryonic stem cells in mice to try to regenerate tissue and they had 70% of mice die from teratomas (cancer), and so it’s not a trivial challenge.”

Basically Ildstad says “it’s easier to control adult stem cells and what’s happening when using embryonic,  it’s been difficult to say okay, don’t go further and become a cancer. Really, with cancer, what happens [is] the stem cell gets out of control.”

LifeNews.com Note: Rebecca Taylor is a clinical laboratory specialist in molecular biology, and a practicing pro-life Catholic who writes at the bioethics blog Mary Meets Dolly. She has been writing and speaking about Catholicism and biotechnology for five years and has been interviewed on EWTN radio on topics from stem cell research and cloning to voting pro-life. Taylor has a B.S. in Biochemistry from University of San Francisco with a national certification in clinical Molecular Biology MB (ASCP).