Ted Harada: His ALS miracle continues to amaze

Crains Detroit Business
Crains Detroit BusinessMay 03, 2013 2:00 PM

You will find that you can last longer, generic viagra purchase look bigger and feel better. The ED occurs while an erection is facing difficulties to produce. viagra no prescription click that These herbal bulk cialis pills are free from additives, preservatives and chemicals. What makes this mineral water pretty incredible is its unique make-up. viagra mastercard india http://www.wouroud.com/order-5654

Ted Harada: His ALS miracle continues to amaze

Stem-cell protesters are blind to the big picture

After stem cell injections, Ted Harada no longer needs his canes

You can understand Ted Harada being more than a little cheesed off when knee-jerk protesters start whining about embryonic stem cells and how it’s against God’s wishes and all that is moral and right to use them in the name of science.

But Harada is too busy still reveling in the seemingly miraculous improvement in his symptoms of ALS to be mad at anyone. Nothing is going to wipe that smile off his face.

Here’s the deal:

Harada, 40, is a former manager at FedEx who first noticed symptoms of ALS in 2009 while playing Marco Polo with his kids in the family swimming pool.

On March 9, 2011, he got an injection of 500,000 stem cells — the cells were derived by Rockville, Md.-based Neuralstem Inc. after a patient donated her fetus’ spinal-cord tissue in 2002 — as part of an 18-operation, 15-patient trial that last 2 1/2 years.

Harada doesn’t know if the tissue was from an embryo that was aborted or one that was miscarried or one that died as a result of an accident. The stem cells he got weren’t from that embryo, they were from cells that begat cells that begat cells that begat cells during 11 years and many generations of cells.

The operations were conducted by Emory University Hospital physician Dr. Nicholas Boulis. The trial was designed, in part, by Dr. Eva Feldman, director of the A. Alfred Taubman Medical Research Institute at UM and director of the ALS clinic at the UM Health System. Boulis is a former colleague of hers at UM.

Harada was one of three patients who got two rounds of injections, the second last August. Researchers monitored all patients for side effects, the trials proved to be safe and last month, the U.S. Food and Drug Administration gave its blessing for Phase 2 trials, to begin later this year in Ann Arbor and at Emory.

Signs of Harada’s ALS diminished noticeably after his first injection, and the improvement after his second injection was even more noticeable.

He hasn’t used his canes in months, his strong grip has returned, he easily walks upstairs to kiss his kids goodnight. On Oct. 20, he was even able to do a 2.5-mile fundraising walk in Atlanta to fight ALS.

“If the walk had been in July, I wouldn’t have attempted it,” he said. “After a third of a mile I would have been done. I would have sat down and said, `Someone come pick me up in a car.’ ”

Harada still has ALS. He still knows the likely prognosis is death. But there’s hope the prognosis of death won’t always accompany the diagnosis, now that there’s clearly some mechanism for improvement that researchers need to understand and refine.

“We’ve got to turn Lou Gehrig’s disease into Lou Gehrig’s chronic illness,” he told me last summer.

Today, Harada told me nearly all the improvement that happened after his last injection is still evident. Wednesday, he underwent his usual round of post-injection testing at Emory. “I’ve been doing great and feeling great. Just now, the left leg showed a little bit of weakness returning, but I’m still so much better than I was before the surgeries. It’s the first time, since August, they’ve noticed any slight weakness.

“It’s clear from the data that the injections reversed my symptoms and slowed down the progression of the disease. I’ve received a blessing. I almost forget I have ALS. I don’t have the constant reminder of having to use the canes. Now, I don’t think about ALS every day. Every couple of days something happens and I think, `Oh, yeah, I have ALS.’ ”

When Feldman told me the good news in April that the FDA had given its blessing for Phase 2 trials, she said Harada would be welcome to apply for another round of injections.

And Boulis briefly told him the same thing in Atlanta. But he and Feldman had overlooked an important detail: The trial protocol calls for patients who have been diagnosed within a certain window of time. Harada had been recently diagnosed when he got his first injection, and the thought, based on how well he did, is that those more recently diagnosed will show more dramatic results.

Alas, the irony is that based on his success, the change in test criteria now excludes him from further participation.

“I’d be intellectually dishonest if I said I wasn’t disappointed, but I’m still the biggest cheerleader for the trials,” he said. “If they can get good results and get to market, I might still be able to take advantage.”

The day after UM and Feldman happily announced Phase 2 trials would commence, loud and strident protesters showed up at UM to bloviate against the use of embryonic stem cells.

They were on TV, they were on the radio. Never mind that the embryo they were concerned about died 11 years ago and that this is a line of cells gathered legally in a process that obeyed all state and federal rules and is finally giving hope to people who no longer are sure their disease is a death sentence.

“I don’t think the protestors understand,” said Harada. “An embryo dying is a one-time tragedy, I know that. But this is a way to turn it into a gift. And it’s a gift that’s done so much good. That’s proved to be life extending.”

Mich. university joins Lou Gehrig’s clinical trial

USAToday

USATodayhttp://www.usatoday.com/story/news/nation/2013/04/18/lou-gehrigs-disease-clinical-trial/2094867/

Mich. university joins Lou Gehrig’s clinical trial

Robin Erb, April 18, 2013

Study is only one if its kind because neural stem cells are injected into the spinal cord.

(Photo: Kimberly P. Mitchell, Detroit Free Press)

Story Highlights

  • University of Michigan joins Emory University in Atlanta in the clinical trial
  • In the study, human neural cells are injected directly into patients’ spinal cord
  • Currently, there is no cure for amyotrophic lateral sclerosis or ALS

Still, a lot of individuals do buy brand cialis not understand the differences between the sexual system and the in-love system. The price should be competitive enough and it needs to be practiced under viagra 50 mg the doctor guidance. viagra 100mg sales The entrance of the vast majority of cases, it might not be related to the procedure in which blood is propelled from heart to the entire portion of the body. When you undergo spiritual therapy together, for the purpose of healing your relationship, you are already sending a message to the Divine Being that you want to look viagra 25 mg http://amerikabulteni.com/2013/04/08/dunyada-tum-zamanlarin-en-cok-satan-20-kitabi/ for.
A clinical trial using human neural stem cells to halt or even reverse the deadly effects of Lou Gehrig’s disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights, Mich., said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, and told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl Murray. “She left us room to cry. She said, ‘Take whatever time you need.'”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

Feldman and others theorize that these new cells, once in the spinal cord, act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The cells were derived from a cell line that dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said.

U-M may recruit ALS patients for stem cell clinical trial

Detroit Free Press
Detroit Free Presshttp://www.freep.com/article/20130417/NEWS06/304170160/U-M-may-recruit-ALS-patients-stem-cell-clinical-trialDr. Eva Feldman is overseeing the clinical trial. / Detroit Free Press

Sexual stimulation is also necessary before ingesting generic cialis viagra. * cialis can be taken ten minutes before sexual performance. There will be obstacles along the way, potholes, detours, bridges generic viagra mastercard out, etc. Folic acid improves energy levels and promotes blood flow to the genitals. viagra soft The drugs that viagra tablet in india have been developed to help men get hard and stay hard during sexual stimulation.

By Robin Erb
Read the full article by clicking here

A clinical trial using human neural stem cells — injected into the spinal cord — to halt or even reverse the deadly effects of Lou Gehrig’s Disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl. “She left us room to cry. She said ‘Take whatever time you need.’ ”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

Feldman and others theorize that these new cells, once in the spinal cord, act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The cells were derived from a cell line that dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said. “This isn’t even about a cure. People would be happy with the treatment.”

Contact Robin Erb: 313-222-2708 or rerb@freepress.com.

Kofi Myler

What’s next?

■A University of Michigan Institutional Review Board will review the protocols for the trial, considering the ethics and science of the experimental procedure.
■ The university cannot begin recruiting until the the board OKs the trial. The approval process could take months.
■ Once approval is given, the research team, made up of doctors, nurses, researchers and others, may begin recruiting. Because the trial will likely involve fewer than 15 patients at U-M, it’s unclear how they will be recruited.
■U-M most likely will post recruiting information on its clinical trials website,www.umclinicalstudies.com. For general information for ALS patients wishing to take part in U-M research, e-mail jkballar@umich.edu.

Kofi Myler
Kofi Myler