The Baldwin County doctor that treated former Alabama football players with adult stem cells also has treated at least two people diagnosed with amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.
One of the ALS patients, former NFL football player and college coach Frank Orgel, recently underwent a new stem cell reprogramming technique performed by Dr. Jason R. Williams at Precision StemCell in Gulf Shores.
Former NFL football player and college coach Frank Orgel has been struggling with ALS for about eight years. (photo courtesy Precision StemCell)
Before the injections, Orgel’s health had declined. He could not move his left arm or leg. He couldn’t walk or stand on his own, he said.
Within a few days of having the stem cell treatment, Orgel’s constant muscle twitching diminished, said Bob Hubbard, director of stem cell therapy at the practice. Within weeks, he was able to walk in a pool of water and stand unassisted.
“I think it’s helped me,” said Orgel, who was a defensive coordinator at Auburn under former head coach Pat Dye. “I’m walking in the pool and I used to drag my feet. Now my left leg is picking up.”
ALS is a progressive neuro-degenerative disease that affects nerve cells in the brain and the spinal cord. The progressive degeneration of the motor neurons in ALS eventually leads to death, according to the ALS Association.
Stem cells, sometimes called the body’s master cells, are precursor cells that develop into blood, bones and organs, according to the U.S. Food and Drug Administration, which regulates their use. Their promise in medicine, according to many scientists and doctors, is that the cells have the potential to help and regenerate other cells.
While Williams’ treatments are considered investigational, he has said, they meet FDA guidelines because the stem cells are collected from a patient’s fat tissue and administered back to that patient during the same procedure.
Orgel, 74, said Williams told him it would take between eight months to a year for his nerves to regrow. He is traveling to Gulf Shores from his home in Albany, Ga., this weekend for another stem cell treatment, Orgel said: “I need to get to where I can walk.”
In recent years, Orgel has gone to Mexico at least three times for different types of treatments, not sanctioned in the U.S. At least once, he said, he had placenta cells injected into his body. “That didn’t work,” Orgel said. “I didn’t feel any better.”
These days, he’s lifting weights and swimming twice a week as part of a physical therapy regimen.
Stem cell therapies
The technique performed on Orgel is called InVivo reprogramming, Hubbard said, which is described as reprograms adult stem cells into neural stem cells.
The procedure involves harvesting adult stem cells from the patient’s own fat, which Williams obtains through liposuction. Then, he uses image-guided therapy to insert the stem cells into the patient’s spine.
The patient is prescribed an oral medication that, as laboratory research has shown, causes stem cells to reprogram, converting them into neural stem cells, according to a written statement from the Gulf Shores medical practice.
Because of their experimental nature, stem cell injections to remedy conditions such as damaged knee joints or injured muscles are not covered by insurance. A typical stem cell therapy with Williams costs about $15,000. The collection of the cells through liposuction, he has said, makes up about half of the overall price.
Williams, a board-certified radiologist, said in a previous Press-Register interview that he spent about four years researching various stem cell therapies, including those collected from bone marrow. He said that the adult stem cells derived from fat tissue seemed to bring fewer chances for complications.
Harvesting stem cells from a patient’s own fat removes the need to culture cells, Williams said earlier this year, explaining that culturing stem cells can be a weeks-long process that may expose patients to risks such as infection.
In recent years, professional athletes such as Denver Broncos quarterback Peyton Manning and New York Yankees pitcher Bartolo Colon, among dozens of others, have acknowledged seeking stem cell injections outside the U.S. to try to help heal injuries.
FDA urges caution
Earlier this year, the FDA issued a consumer warning about claims regarding stem cells. In it, Stephanie Simek, deputy director of the FDA’s Office of Cellular, Tissue and Gene Therapies, said that stem cells from bone marrow or blood are routinely used in transplant procedures to treat cancer and disorders of the blood and immune system.
The document cautioned consumers, however, to make sure that stem cell therapy treatments have been approved by the FDA or are being studied under a clinical investigation allowed to proceed by the agency. “There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body,” Simek said.
Cells in a different environment may multiply, form tumors, or may migrate elsewhere in the body from the spot where they were placed, according to the FDA warning.
While several dozen clinical trials involving various forms of stem cell therapies are under way or have been announced around the world, few have included adult stem cells found in fat tissue.
Williams has said that universities and research groups have been slow to move forward because research funding tends to steer toward new drug therapies. He said that he is up front with his patients, telling them that results cannot be predicted.
“This new technique of InVivo reprogramming shows great promise for possibly repairing or regenerating nerve cells,“ Williams said in a written statement. “That means it may open up opportunities for treating several neural conditions such as spinal cord injury, stroke, Parkinson’s and Alzheimer’s disease.”
Williams said the new technique has been shown to help increase the number of neural stem cells that are transferred back into a patient.
“We are hopeful this will indeed help us heal or regrow nerve cells,” Williams said. “However, it is still too soon to really know.”
By Eleanor Bradford
BBC Scotland Health Correspondent
The first patients to take part in a clinical trial of a stem cell treatment for stroke have seen reductions in their disability, according to doctors.
Six patients in the west of Scotland had human stem cells inserted close to the damaged part of their brain.
After receiving the treatment, they saw improvements in the limb weakness they suffered as a result of their stroke.
Howeve, doctors have cautioned against reading too much into the early results of the clinical trial.
It is the world's first trial of a neural stem cell therapy for stroke.
Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.
The trial is being conducted at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow, and is being led by Glasgow University neurologist Professor Keith Muir.
He said: "So far we've seen no evidence of any harmful effects. We're dealing with a group of people a long time after a stroke with significant disability and we don't really expect these patients to show any change over time.
"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."
Patients had human stem cells inserted near the damaged part of the brain
Professor Keith Muir was intrigued by the results
All six patients suffered a stroke six months to five years before they were recruited to the trial, and all had been left with limb weakness.
The patients were assessed using the National Institutes of Health Stroke Scale.
Prior to the study, the first five patients had a median score of eight. Three months after treatment their median score had fallen to four.
The sixth patient was treated less than three months ago. Six further patients will be treated as part of this Phase 1 trial.
Professor Muir said he was "intrigued" by the early results.
He added: "We know that if you're involved in a trial you are going to see patients change in behaviour, particularly if you're doing something invasive, so we need to be very cautious indeed in interpreting these results.
"However, that said, it is not something we'd anticipated seeing in this group of patients."
Further trials are needed to establish whether stem cells actually help the brain repair damaged tissue.
Michael Hunt, chief executive officer of the company developing the treatment, ReNeuron, said: "The clinical trial is primarily a safety study and we must therefore treat any of the observed early indications of functional benefit with considerable caution at this stage.
"That said, we remain encouraged by the results seen in the study to date and we look forward to providing further updates."
Now 13, he is still getting better and better.
Lisa Biermann has been dedicated to the improvement of her son’s quality of life. Thus far, she has experienced the miracle of hearing her son speak, as well as many other accomplishments, after she was told he would never be able to perform everyday tasks.
THANX TO PAMELA COTE
Tyler Biermann is a lot like other sixth grade boys. He loves working on his computer, playing video games, riding a bike and watching television. He has a silly sense of humor and is very curious about the world around him.
What makes Tyler so very special is the great physical hurdles he has overcome in the past 12 years of his life to be able to do the things that most boys his age seem to do so effortlessly.
When Tyler was born, the umbilical cord was wrapped around his neck, causing a lack of oxygen to his brain that led to Tyler suffering a stroke during delivery. The stroke caused damage to the back of Tyler’s brain. Tyler was diagnosed with cerebral palsy and his mother, Lisa Biermann, was told to expect the worst: a child who would never walk, talk, or have any chance at a normal life.
Lisa refused to give up hope. She tried everything she could to help Tyler. Tyler could not walk because his feet would not sit flat on the floor. She tried botox injections every three months, braces, casts and even ankle cord surgery. Nothing worked.
Lisa said Tyler could not communicate with her at all. She never knew when he was in pain because he was unable to tell her.
Tyler was considered to be blind, with a prescription that was over nine units nearsighted, and his eyes jumped around. Even with glasses, he could not focus his vision, and doctors did not believe he could see, or ever would see.
Until he was 8 years old, Lisa would carry Tyler from his classes at Woodland Park Elementary.
When Tyler was 8, he had a seizure. A USA stem cell doctor heard about Tyler and offered to help him with umbilical cord stem cell therapy. Lisa said she thought hard about it, and because she had tried everything else and nothing had worked, she decided to try the stem cell therapy, which she was assured (correctly) that it had no serious side effects.
In December 2007, Lisa took Tyler to Mexico for the treatment, which had to be done in Tijuana because stem cells injection was not legal in the United States.
Nor is it today, five years later. Nor will it be anytime this decade, according to Don Margolis . Three months later, they went for a second injection.
The stem cells were given to Tyler intravenously for a period of approximately 45 minutes.
Lisa said within weeks, she saw monumental changes in Tyler. All the milestones he never reached as a baby, he began reaching.
Within three months Tyler could put his feet flat on the floor and could walk independently. At six months post-treatment, he no longer needed the painful braces that gave him bunions.
Also within the first three months, Tyler took off his glasses and told Lisa, “no see, Mom.” When Lisa took Tyler to the eye doctor, his vision had improved from nine units nearsighted to 5.5. At six months post-treatment he had improved to four units. He is now at about 1 unit nearsighted and his doctor does not believe that he needs to wear his glasses. Even more impressive is that he can communicate and answer questions posed by the eye doctor.
In fact, Tyler, who could not communicate at all before his stem cell treatment, can now say hundreds of words. He can recite the alphabet. Tyler can spell and is even starting to read. He makes the honor roll and has received two spotlight awards from school for his progress.
Tyler helps with household chores, can walk up and down the stairs and pour himself something to drink. In December, he decided that he wanted to ride a bike and could not be discouraged from trying. To her great surprise, Lisa said Tyler not only climbed onto his friend’s bike, but he started peddling as well.
There have been setbacks along the way. Last April, Lisa took Tyler to the doctor because his blood pressure was very high. The doctor noticed that Tyler had no pulse in his legs and had an MRI performed.
The MRI showed that Tyler had a rare birth defect. He only had two heart valves and his aorta was pinched. The MRI also showed that Tyler’s veins and arteries had formed a web around his heart and major organs to supply them with blood. Lisa credits the stem cells for protecting Tyler’s organs.
Tyler had surgery to repair his aorta and has recovered well.
“He improves every single day,” Lisa said.
Lisa hopes to take Tyler for another stem cell treatment this summer. She wants everyone to know that there is hope and shares her experiences and links to others’ stories on her website, www.stemcellhelps.com
Manhattan basketball's Torgrim Sommerfeldt turned to stem cell treatment to get him back on court
Sophomore forward from Norway has Jaspers flying high
JEFF BACHNER/FOR NEW YORK DAILY NEWS
Torgrim Sommerfeldt is back on the court for Manhattan after lengthy rehab and stem cell surgery.
From a young age, Torgrim Sommerfeldt set his sights on chasing his sports dream, one that had nothing to do with skiing, bobsledding or speed skating, winter sport staples in his native Drammen, Norway.
The 6-6 Sommerfeldt wanted to follow his two brothers and sister to the United States, soak up the college experience, and play a little college hoops along the way.
“It’s been my dream since I was 10 years old, especially to come to America,” says Sommerfeldt, a sophomore forward at Manhattan College. “I watched my brothers and sister go to the University of Missouri on track and field scholarships. When I was young I got a taste of what college life was like here and it was something I wanted to experience.”
Sommerfeldt didn’t know at the time that for his American dream to come true, he would eventually need to turn to a new and, in some circles, controversial, treatment: stem cells.
In early 2009 Sommerfeldt’s dream seemed to be taking shape. After opening eyes internationally while playing with Norway’s national team and turning some heads with his performance in the 2008 Nike Hoop Summit in Portland, Sommerfeldt verbally committed to Wake Forest. A scholarship to an ACC school, two yearly matchups with Duke and North Carolina, playing in arguably the top basketball conference in the nation? Yes, the dream had finally arrived for Sommerfeldt.
Except Sommerfeldt never donned a Wake Forest uniform, never got a chance at showcasing his sweet stroke against Carolina or Coach K. Instead, 2009 was the start of a series of surgeries and medical setbacks that kept Sommerfeldt sidelined for much of the next three years. Six surgeries in all, four on his right knee, two on the left, with bouts of tendinitis and a stress fracture thrown in for good measure.
Wake Forest? It wasn’t waiting around.
“They pulled the scholarship,” Sommerfeldt says. “They moved on.”
Sommerfeldt retreated to Norway, where he took a year off to rest his knees. Only there were more surgeries to come. He suffered from patellar tendinitis in both knees, which prompted procedures to remove parts of the tendon to alleviate the pain.
Still, despite his lack of playing time and mounting surgeries, schools kept tabs on Sommerfeldt.
“Seton Hall and Rutgers had interest, so did Florida International,”
Sommerfeldt says. But former Manhattan coach Barry Rohrssen and his former assistant Scott Adubato instead coaxed him to Riverdale with the hope that once his knees were sound, he could provide the kind of scoring punch that had much larger schools tracking him.
But Sommerfeldt’s luck didn’t change. He tore the meniscus in his right knee last summer only to rehab once again, and when he finally appeared ready to start the season for the Jaspers last November, a stress fracture put him back on the sidelines.
“It took a while to come back from the meniscus surgery because of all the previous surgeries,” Sommerfeldt says. “But when I finally did come back I got the stress fracture. It was so frustrating. I can’t really put it into words. I’d finally got into a rhythm and was finally ready to contribute to the team. It was frustrating especially because of such a long period of time without really playing. It was devastating.”
The usual protocol of rehabilitation followed. Again.
“He had exhausted almost every other conservative method we could possibly think of,” says Dr. Anthony Maddalo, Manhattan’s team doctor who doubles as the Rangers’ assistant team physician. “He was bothered by chronic patellar tendinitis in both knees, and he had never really recovered from those operations (in Norway). He was in pain constantly. He couldn’t walk around campus without pain. We tried physical therapy, ultrasound, types of electric stimulation, exercise and stretching but nothing worked.”
With limited options, other than more surgery, Sommerfeldt and Maddalo decided to try something outside the box, a last resort as it were.
They turned to stem cell treatments.
“It really was now or never for me,” Sommerfeldt says. “I don’t think mentally I could sit out another year.”
With that mindset, Maddalo contacted Dr. Steven Victor from Lenox Hill Hospital, who is also CEO of Intellicell BioSciences Inc., in New York City.
Victor’s process amounts to harvesting fat cells from a patient and separating stem cells from the fat. It’s a procedure similar but not exactly like the one former Yankees pitcher Bartolo Colon underwent prior to the 2011 season.
“What we do is take two ounces of fat from people and then we use our special technology, we use sound waves and water, where we actually separate the stem cells from the fat,” Victor says. “Then we return the stem cells to the orthopedic surgeons, in this case Tony Maddalo, and they inject the cells into where the problem is. These cells are actually anti-inflammatory and they increase blood flow and grow new tissue.”
Colon’s procedure included using the addition of enzymes, which is not approved by the FDA and can only be performed outside the country, according to Victor.
Sommerfeldt’s first treatment came in December of 2010, his second one about six weeks later.
Sommerfeldt didn’t notice any changes right away and, due to the meniscus surgery and stress fracture, says it was hard to tell when the pain in his knees started to subside.
But after spending almost the entire 2010-11 school year on crutches, Sommerfeldt finally got into his first college game on Jan. 20 when Manhattan played at Marist.
He played just two minutes, didn’t score, didn’t even take a shot in the Jaspers’ 61-44 victory. But that was OK. The dream was finally taking shape again.
“It was fun but it wasn’t what I hoped it would be,” Sommerfeldt says. “I really wanted to be able to do something out there, but it’s a process and I’ve come to peace with that. I may not be the player I once was, but all I can do is try and get better every day.”
The crutches, his constant companion since arriving at Manhattan, have been retired and Sommerfeldt says every day he is making progress, baby steps toward his goal of being a full-time player, the kind of player an ACC school once wanted as its own.
“It was frustrating to feel the pain with every step you take,” Sommerfeldt says. “But that part is gone now. Now I can be on the court practicing and doing conditioning without the agony. It’s definitely a step forward obviously. A year ago I would never think I’d be at this point. I believe the stem cells helped and I wanted to try it. I wanted to do whatever I needed to do to play again and pursue my dream.”
So why does Dr. Maddalo believe it’s the stem cell treatment that is finally proving to be the answer to Sommerfeldt’s comeback?
“We tried everything and not just for a while,” Maddalo says. “There was a year before he got to us and Wake Forest treated him. Then therapy, exercise, nothing had an effect on him. Then we give him two of these treatments and he turns around and starts to be able to be active. That speaks well for the treatment.”
Doctors Maddalo and Victor think this treatment will become more prevalent in the sports world.
“Stem cell work is still in its infancy,” Maddalo says. “The orthopedic applications are just becoming evident. Everybody read about Bartolo Colon last year and that was one of the orthopedic applications that sort of splashed on the scene and became the buzz of the town and Major League Baseball.”
Now Sommerfeldt hopes to make some buzz himself over his last two years and change at Manhattan.
“Of course it crossed my mind that maybe I simply couldn’t play anymore but I wasn’t ready to give up on my dream,” Sommerfeldt says. “If this works, great. If it doesn’t I’ll walk away knowing I tried everything I could.”
Antony Atala at Wake Forest explains why
To many people, the idea of growing replacement body parts in the lab sounds like modern-day science fiction. People are often surprised to learn that this notion of harnessing the body's natural regenerative powers isn't new. In fact, aviator Charles Lindbergh did research in this area back in the 1930s in hopes of finding a solution for his ailing sister-in-law. The idea has endured because of the desperate need for replacement organs. Every 30 seconds, a patient dies from diseases that could be treated with organ or tissue replacement.
Today, regenerative medicine is becoming science fact. In the area of cell therapies, advances include a recent report that cardiac stem cells were able to improve heart function in a small group of patients with heart failure. In the area of tissue engineering -- or growing organs in the lab -- skin, cartilage, bladders, urine tubes, trachea and blood vessels have all been engineered outside the human body and implanted in patients. While these advances are currently helping small groups of patients through clinical trials, the goal of regenerative medicine scientists is to expand the applications of regenerative medicine to a wider range of diseases and also to larger groups of patients.
The U.S. Department of Health and Human Services has called regenerative medicine the "next evolution of medical treatments". With its potential to heal, this new field of science is expected to revolutionize health care. Because of the promise of regenerative medicine, the U.S. military has funded an $85 million effort to develop regenerative medicine treatments for wounded warriors.
Regenerative medicine offers the potential to improve the quality of life for many, but also to combat rising health care costs. Early estimates project that regenerative medicine therapies will result in direct health care cost savings in the United States of $250 billion per year for the chronic diseases of renal failure, heart failure, stroke, diabetes, burn and spinal cord injuries.
In my TED talk, I highlighted some of the work of the Institute for Regenerative Medicine at Wake Forest School of Medicine in Winston-Salem, NC. Our team of more than 300 scientists is working on cell therapies and developing replacement tissues and organs for more than 30 different areas of the body.
For example, the talk highlights our still-experimental work to engineer a human kidney. Being able to replace solid organs such as the heart, liver, kidney and pancreas is considered the "holy grail" of tissue engineering. That's why we're pursuing multiple strategies in this area: cell therapies, tissue "inserts" to augment an organ's function, and "printing" replacement organs.
At TED, we demonstrated 3-D printing technology, already used in a variety of industries -- from auto parts to concrete structures. Our goal, or course, is to apply the technology to organs. The project is based on earlier research in which we engineered miniature kidneys using biomaterials and cells. In animals, these structures were shown to be functional, in that they were able to filter blood and produce dilute urine.
This printer, while still experimental, is being explored for organs such as the kidney and structured tissue such as the ear. The ultimate goal is to use patient data, such as from a CT scan, to create a computer model of the organ we want to print. This model would be used to guide the printer as it layer-by-layer prints a replacement organ made up of cells and the biomaterials to hold the cells together.
For me, the real highlight of the TED experience was a reunion with Luke Masella, one of the first patients to receive a lab-engineered organ -- a bladder. Seeing Luke again and hearing about his successes reinforced in my mind the ultimate goal of regenerative medicine -- to make patients better. That in itself makes it an idea worth sharing in 2012 and beyond.
WATCH ANTONY ATALA'S EXCITING VIDEO---17 minutes---