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.”
CHENNAI: For nearly three years, Sundar (26) was waiting to be told that he could to regain control of his bladder and move around. Sundar, who fell off a tree, injured his spine and was paralyzed below the navel. In 2011, when doctors at Laksha Hospital in Chennai told him there was hope in the stem cell therapy trials, he signed the consent form.
Mumbai-based Dr B S Rajput, consultant orthopaedic and stem cell transplant surgeon at Breach Candy Hospital, told him he would inject stem cells drawn from his own body into him to repair the shredded network of nerves crisscrossing the spinal cord. At a press conference on Monday, Sundar, a farmer, walked with support, and smiled at flashing media cameras. "I tried everything before agreeing for stem cell therapy. I was told there is no hope of walking again and I was bed ridden. I chose stem cell therapy as I had no other option. Now, I have complete bladder and bowel control," he said, shaking hands with Dr Rajput.
In 2008, Sundar suffered a serious spine injury after a fall from a tree. After initial treatment, doctors told him he had suffered post-traumatic paraplegia and that he would have to remain on bed. Sundar then met Laksha Hospital managing director Dr Senthil Kumar who told him about Dr Rajput and his experience in stem cell therapy. After the informed consent form was signed, Sundar was brought for trial on April 26, 2011.
Dr Senthil Kumar and Dr Rajput hope Sundar's condition would further improve over time. They did a similar transplant on a 4-year-old boy with cerebral palsy. "It's a trial, but these tiny cells are helping us build big hopes," said Dr Senthil Kumar.
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---
One of the Toughest:
Ava starts her journey towards a more normal life.
Two-year-old Ava McCulloch has a reason to smile - she's starting to feel better.
Ava was born with Spina Bifida, a neurological disorder that makes it difficult for her to walk.
"It affects nerves in the body below that point where her spinal cord was sticking out at birth, so there's some nerve damage that was done," said Ava's mother Jessica.
After doing some online research, Jessica discovered a procedure that could change her daughter's life - stem cell treatment. The procedure isn't available in the United States, so the McCulloch family took a trip around the world to China.
"They use these stem cells, which came from healthy Chinese babies, and they put them in by IV into her feet," said Jessica.
The doctors use stem cells from umbilical cords instead of embryos. Jessica said she was told not to expect any results right away - but that's exactly what happened.
"We started the treatment and the therapy, and after about the third stem cell treatment and the seventh day of acupuncture, she started crying," said Jessica.
Those tears meant that Ava was able to sense the pain for the first time. Jessica said her daughter is one step closer to walking without ankle braces.
"Now that we have seen things happen, which this isn't the end of it, more progress is suppose to come months down the road, and it's very exciting," said Jessica.
Jessica said that Ava will need to continue her therapy, and the family is trying to return to China within the next year for another procedure. Until then, Ava's smile is all the encouragement they need.