Biomedicine

Human Tests of Embryonic Stem Cell Treatments Planned

(Page 2 of 2)

  • Friday, August 4, 2006
  • By Emily Singer

The researchers also want to make sure the transplanted cells don't develop into teratomas, a type of tumor associated with the injection of embryonic stem cells. Okarma says this is an unlikely side effect, since the Geron treatment is made up of differentiated cells rather than stem cells. Still, the researchers have searched for teratomas under various experimental conditions and seen no signs of the tumors, he says. The company plans to continue safety testing for another year, at the request of the Food and Drug Administration, and will then file for permission to start human tests.

Plans for the trials are already underway, though. According to Okarma, researchers have almost finished the protocol for the experiments and are in discussions with spinal cord injury centers throughout the country that will run the actual tests.

Initial clinical trials will focus on patients with newly acquired, severe spinal cord injuries -- those with damage in the thoracic region (between the neck and lower back) who cannot move or feel anything below the site of injury. These patients usually undergo surgery two weeks after the injury to stabilize the spine. For those participating in the trial, surgeons will inject oligodendrocyte cells into the site of the injury. Patients will then be followed for signs of improvement.

The first phase of the human testing will assess mostly safety, which is the conventional procedure in testing new drugs. But rehabilitation therapists will also look for signs of motor improvement, comparing the results with control patients who do not receive the injections. If initial tests are successful, Geron plans to test the therapy in patients with less-severe spinal cord injuries. The company is also developing stem-cell-based treatments for heart disease and diabetes. "We hope to test a new cell type each year," says Okarma.

Geron's pilot trial will likely become a test case for future trials of embryonic stem cells treatments. As stem cell research moves from the research lab to human trials, hospitals, doctors, and scientists conducting the tests will face many of the same regulatory and ethical issues faced by scientists using stem cells for research purposes. For example, stem cell research requires complex approval procedures from institutional review boards and an array of ethical oversight boards. "I was shocked to find out many institutions outside California don't have ESCRO [embryonic stem cell research oversight] committees," says David Magnus, an bioethicist at Stanford University. "That's where I think one of the big challenges is going to be."

Still, scientists are confident they will be able to overcome the obstacles. "Stem cell research is like a plant creeping out of crack in the desert -- there's no way to keep it down," says Keirstead. "Where it's allowed to flourish, it blooms."

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Guest (Greg W)

  • 2021 Days Ago
  • 08/04/2006

Christopher Reeve

Does anyone have info on how far
Christopher Reeve took this technology?

Thanks,
Greg W

Reply

Guest (poncedeleon)

  • 2016 Days Ago
  • 08/09/2006

C. Reeves website link

CR was a facilator, not a scientist.

Link to CR website:

http://www.christopherreeve.org/site/c.geIMLPOpGjF/b.899265/k.CC03/Home.htm

Reply

Guest (injured but not down)

  • 2020 Days Ago
  • 08/05/2006

the article presents information that...

...sounds almost too good to be true.  It's about time!  And if it a fraud, then we will still keep the faith...somebody is going to solve this mystery sometime.  But, no one should die to serve another living soul.  The abortion mentality is quite wrong.  Our day will come...developing

Reply

Guest (Quasi Modo (Partly formed))

  • 2019 Days Ago
  • 08/06/2006

Religion Vs Cure

If this cure works reliably, you will see few bible thumpers refusing the chance to walk again, no mater how the fix is done. If someone decides to forgo walking again because God wouldn't like it; more power to them and their caretakers.

Reply

Guest (Tom)

  • 2018 Days Ago
  • 08/07/2006

Keep Politics Out

The writer of the article incorrectly uses the future tense when she writes, “As stem cell research moves from the research lab to human trials, …”.  There are already a large number human trials being conducted as a result of research conducted with non-embryonic stem cells, versus one for embryonic stem cells, and there are a significant number of treatments that have been approved based on adult stem cells, versus zero for embryonic stem cells.  Could it be that the writer has a political motivation in withholding information about non-embryonic stem cell research and successes?  Too bad when science articles have a political slant whether the slant was or was not intended.

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Guest (poncedeleon)

  • 2016 Days Ago
  • 08/09/2006

Read the Article's Title Again

While true that there are ASC therapies in trial, the title of the article contains EMBRYONIC STEM CELLS. It doesn't say adult stem cells or cord cells. I see no slant. Besides, hESC appear far superior to ASC because they are scalable and are not patient- specific treatments.

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cormac mcadam

1 Comment

  • 1827 Days Ago
  • 02/14/2007

Re: Keep Politics Out

soon the better i am t6 t10 and i would volunteer for human trials.If politicans were in a wheelchair I wonder what they would do.

Reply

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keane10

1 Comment

  • 1113 Days Ago
  • 01/28/2009

stem cell treatments

So many people are against these treatments but I wonder how they would feel if it hit home.  No one likes to see their love ones suffering. Most of the people against it would change their minds if it they themselves were injured or one of their family members.

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