Obama Admin OKs Another Human Embryonic Stem Cell Trial

Bioethics   |   Steven Ertelt   |   Jan 3, 2011   |   5:59PM   |   Washington, DC

The Obama administration has approved an application submitted by cloning company Advanced Cell Technology to move ahead with a trial with patients receiving injections of embryonic stem cells.

Although embryonic stem cell use in animals faces immune system rejection issues and cause tumors, the Food and Drug Administration cleared ACT to start its second try with derivatives of embryonic stem cells. ACT scientists applied in 2009 to carry out a clinical trial on patients suffering from macular degeneration and they expect the trial to begin soon now that it has been approved.

“ACT is now the first company to receive FDA clearance for two hESC (human embryonic stem cell) trials, and is now a true translational leader in the field of regenerative medicine,” Gary Rabin, Interim chairman and chief executive, told Reuters. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques.”

But Dr. David Prentice, a former biology professor at Indiana State University who is now a fellow with the Family Research Council, tells LifeNews.com he believes the trial will put people at risk because the safety of the use of embryonic stem cells has not been proven.

“ACT’s green light by the FDA for this experiment puts more patients in danger,” he said today. “There is still a great concern even among many embryonic stem cell scientists that the headlong rush by the Obama administration to promote embryonic stem cell trials is preliminary and risky.”

“A major concern for safety is the distinct possibility of tumor formation by embryonic stem cells, since their primary feature is unlimited growth,” he explained. “And since embryonic stem cells are derived from the destruction of young human embryos, the trial relies on cannibalizing young lives.  We can only hope that ACT has good insurance.”

Because of the concerns with using embryonic stem cells in animals, ACT scientists are not technically using them but have substituted a derivative that involves changing the embryonic stem cell into an adult stem cell/progenitor, but Prentice says even those could cause similar problems. 

Adult stem cells do not present the immune system and tumor problems nor are they unethical because they are obtained without the destruction of human life as is the case with ESCR. The adult variety has already helped dozens of patients facing a myriad of diseases or medical conditions.

The company indicates it hopes to begin trials in a couple of months and to begin trials in Europe later this year as well. In its trial, ACT will examine the ability of the cells to help patients with dry age-related macular degeneration, which is the most frequent cause of vision loss in people over 60 years of age. Twelve patients will be enrolled in the study at multiple clinical sites. Although many sites may be considered, sites that are currently under consideration are the Jules Stein Eye Institute at UCLA and the Ophthalmology Department at Stanford University School of Medicine.

In November, the FDA cleared ACT, based in Massachusetts, to move ahead with a trial involving embryonic stem cell derivatives on patients with a progressive form of juvenile vision loss, known as Stargardt’s disease.

When rival cloning company Geron pursued embryonic stem cell research trials in human patients in 2008, some scientists said the company was doing so prematurely.

“The fact that Geron’s entire study hinges on this one experiment in eight moderately injured rats is tenuous in terms of efficacy,” one unnamed researcher told TheStreet. “We don’t know what will happen when these cells are placed into a human, which is the reason immune suppression is required.”

“The risk is that these are not patients you would otherwise want to have on immune suppressants because the severity of their spinal cord injuries, the trauma they’ve suffered, their surgery and wounds make them more susceptible to infection,” he added. “If one patient gets a tumor from the Geron therapy, it will be catastrophic.”

The FDA ultimately made the decision to stop human trials involving embryonic stem cells when Geron came calling and decided to review studies of the therapy, called GRNOPC1, in its use with animals.

Later reports indicated problems associated with the animals in Geron’s studies prompted the FDA to halt the human trials. Specifically, the animals developed cysts at the injury sites after the injections.

At the time, Wesley J. Smith, a bioethicist, said he thinks the research done on humans using cells from aborted babies showed eventual problems and he believes the FDA needs to significantly slow down Geron’s plans to proceed quickly.

“You know, tumors formed in a child given fetal cell treatments three years after the injection, and so I wonder how long an animal would have to be followed to determine safety,” he said.

“And we can’t forget that the company apparently has not tested the product in large animals, and so there is some swimming in the dark here,” he added. “Nevertheless, the FDA did the right thing here in terms of pure safety.”