More news on clinical trials for stem cell cures for some of mankind’s most dreaded diseases emerged Tuesday from the World Stem Cell Summit in Detroit.

Thomas Okarma, president and CEO of Menlo Park, Calif.-based Geron Corp., talked about his company’s application to inject embryonic neuron stem cells in people paralyzed by spinal cord injury.

Animal tests in more than 2,000 spinal cord-injured rats have shown the stem cells don’t cause tumors or increases in phantom pain, and aren’t rejected by the immune system — and they work to rebuild spinal tissues.

The most amusing slide in Okarma’s PowerPoint was a tabletop of printed binders — the company’s 22,500-page Investigational New Drug application to the United States Food and Drug Administration to begin human trials.

Okarma said it’s the largest IND the FDA has ever received.

“It does speak to the non-sustainability of this process,” Okarma said. “A $45 million exercise to enable a safety study for 10 patients is very difficult to execute.”

Okarma said Geron is now recruiting and screening its first patients. The Phase 1 trial will test only the safety of the stem cells, not their efficacy. But Okarma said animal tests have shown the cells spare tissues near injury and help injured tissues regenerate, including promoting the growth of new blood supplies.

The cells may also be useful in treating injuries caused by stroke, as well as multiple sclerosis and Alzheimer’s disease.

Okarma said he looks for ward ot the day when scalpel and operation are replaced by “a single injection of live cells that permanently restores the structure and function of cells damaged by disease or injury.”

And he said all stem cell advances are threatened by those who believe that harvesting stem cells from a blastocyst of five days’ gestation — produced for in-vitro fertilization and destined for the trash — is equivalent to killing a human being. He advised those attending the conference to put pressure on their legislators to keep embryonic stem cell research legal.

Meanwhile, University of Michigan professor Eva Feldman and her partners at Emory University in Atlanta and Rockville, Md.-based Neuralstem Inc. presented more information on their ongoing clinical trial of treating Lou Gehrig’s disease, or ALS, by injecting stem cells into the spine. The company has also started the process asking for FDA permission for a clinical trial to treat spinal cord injury.

“You can think of our product as a new set of wires,” said Neuralstem chief scientific officer Karl Johe. “When a wire within our central nervous system breaks, we are trying to mend that broken wire by supplying more wires.”

Nicholas Boulis, a neurosurgeon at Emory, described the physical procedures required to inject stem cells into the spine without causing spinal cord injury.

And Jon Glass, director of Emory’s ALS center, described why the group chose ALS as a target. It’s a horrible disease, killing its victims within an average of three years by destroying nerve tissue, so muscles waste away, eventually killing by wasting the muscles that allow us to breathe — all while the victim’s brain remains perfectly functional. It strikes a fairly small number of people, 30,000 in the United States a year. It strikes adults, with an average onset age of 56.

“We chose ALS because it is a disease of adults, meaning they can make their own choices about participating in the study, it’s easy to diagnose, and its sufferers will be dead within a few years,” Glass said.

Glass admitted researchers don’t know whether the stem cells will work, or whether the new nerve cells will be subject to the same unknown process that causes ALS in the first place. But he said that in animal studies, the stem cells greatly slow the progress of the disease.

The World Stem Cell Summit concludes Wednesday.

(c) 2010, WWJ Newsradio 950. All rights reserved.

Comments (5)
  1. Patricia Taylor says:

    Harvesting stem cells from a blastocyst of five days’ gestation — produced for in-vitro fertilization and destined for the trash — IS EQUIVALENT TO KILLING A HUMAN BEING. Why don’t you specify right from the beginning that the alleged stem cell cures you’re talking about are embryonic stem cells which involves the the deliberate taking of human life. The end does not justify the means – in other words, you don’t destroy human life to possibly save a human life. Why do these people refuse to reallize the positively life saving use of adult stem cells which is a totally ethical, moral means to save and improve life. And adult stem cells have been proven to work on many diseases. I personally know of someone who has been cured of Leukemia.

    God help us!

    1. David Williams says:

      Patricia, Lets see how you feel about that when YOU or one of your kids has a serious injury or disease that can only be cured by this type of stem cell. Get off your high horse and get real. Abortions happen every day whether we like it or not (I don’t). But they always have and always will. A blastocyst is not a baby. It is potentially a baby in the future… maybe if everything goes right. We might as well use this wasted opportunity to save many lives!

      1. Jason Young says:

        David I am with you, I am also against abortion!! I recently was in an accident and am now paralyzed from the waist down. I am 36, married and have 5 kids. I feel that if these blastocysts are going to be discarded anyway then why not save or improve someones life with them. Is it really any different than someone being an organ donor?, the act of using ones life to save another!!

  2. acicicuoubaby says:

    Diky za zajimavy blog

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