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FOX Medical Team

Henry County man undergoes experimental ALS stem cell surgery

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ATLANTA -

A Henry County father of three has gambled on a risky, cutting-edge spinal surgery not once, but twice.

Ted Harada is the 15th and final patient to undergo a human stem cell transplant for amyotrophic lateral sclerosis (ALS) patients. He's part of an Emory study being watched all over the world.

The surgeons aren't just injecting cells into the spinal cord -- they're exposing the spinal cord,  It controls every breath, every movement, every muscle.

Ted and Michelle Harada have been down this road before. The two have been married 18 years. Ted, 40, was diagnosed with ALS two years ago.

"I know it's the right thing.  And I know it's the right thing not just because it will help me, but because there's a lot of people out there that need help," said Harada.
    
Ted knows ALS, also known as Lou Gehrig's disease, will progressively shut down his muscles, until he can't breathe on his own.

Ted volunteered for the first-ever human stem cell trial for ALS at Emory. He said that he's taking the risks for his three children – a 14-year-old son, 12-year-old daughter and 8-year-old daughter.

"But that fact that it was so cutting edge of science and medicine is what appealed to me," said Harada.

Doctors are using stem cells taken from a fetus aborted 12 years ago. They've been cultured and multiplied in a lab by a company called Neuralstem. They're injecting them directly into the spinal cords of people with ALS.

Seventeen months ago, the cells transplanted into Ted's lower spine, which controls his legs.

"Now this is a disease that doesn't get better.  So we don't see patients who spontaneously get better. It just doesn't happen," said Emory neurologist  Dr. Jonathan Glass.

But Ted did get better. Soon he could walk through his McDonough neighborhood without a cane -- the one patient of 15 study volunteers to measurably get stronger.

"How could I not believe in it, when I've seen what it's done, for whatever reason?  I mean, I understand it's a safety trial, but you still can't deny or ignore the results I've seen," said Herada.
 
"I have difficulty explaining it --  it was unexpected," said Glass. "It was nice to see."

But recently the weakness has come back, So, Ted returned for one more surgery.

"I told him the risks, he knows the risks, and the risks are large," said Glass.

"But there's part of me that has to say, ‘Hey, it worked once, why can't it help again,'" said Ted.

Before Ted's second surgery began, Glass had to make sure the stem cells were still viable. To go forward, at least 70 percent have to be alive. In Ted's case, 86.3 percent were alive.

It was neurosurgeon Nick Boulis' 18th stem cell transplant at Emory.
    
"We're going to do five injections of the cervical spinal cord," said Boulis.

The Emory/University of Michigan team focused on the neck because the nerves there control breathing.
       
"Because that's why people die.  People die of ALS because they can't breathe," said Glass.

Dr. Boulis and the team carefully teased open the most delicate, dangerous, real estate in the body: the cervical spinal cord. A few feet away, Dr. Glass drew the stem cells into a hair-thin tube, about 100,000 at a time.
 
"And then we'll do that five times, so it will be 500,000 cells he'll get," said Glass.

The cells were injected into a two centimeter section of Ted's spinal cord. The only goal of this trial  is to prove this surgery, and these cells are safe, not whether they work. But lab studies show the stem cells may help damaged or dying spinal nerve cells repair themselves.
       
After almost six hours in the operating room, the surgery was complete.

Nothing is promised, nothing guaranteed. But there's hope. And for the Haradas that's enough.

Five days out, Ted says he's doing OK.

Now, the Emory-Michigan team will take all of its safety data to the Food and Drug Administration to ask permission to move on to the next phase of the trial. That could take about a year.

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