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.”
How Standard Medicine tried its best to destroy a life and how a VERY smart lady decided to run away from the killers toward something else.
Please do not take this as a criticism of a doctor, but rather of a profiteering medical system which most MDs are forced to participate in.
HOW THE PROFITEERS TRIED TO KILL HER IN THREE STEPS:
In 2009, she went in for her annual medical checkup. All was well but there was something the doctor wanted to take a closer look at. (STEP 1)He ordered a CT scan with contrast and an iodine dye was used. About a month later, something odd happened - she began feeling more tired than normal and had some other odd symptoms.
After getting a blood test, she was informed that her kidneys had failed. The toxic levels in her blood were so high her doctors wondered how she was still alive, let alone still walking around. Immediate actions were put in place to help her kidneys while more tests were done. They installed a tunneled venous access catheter (a connection port) in her chest. Months went by while she was doing dialysis three times a week. Various medical tests and reviews from some of the best kidney doctors in the United States failed to discover what was wrong with her kidneys. There was a possibility that she had a reaction to the iodine called Contrast-Induced Nephropathy, which turns out to he the third most common cause of hospital-acquired kidney failure in the United States and Europe.
After several months of hearing that (STEP 2) steroids were highly recommended and that perhaps she might want to consider (STEP 3) a kidney transplant, she decided to look into other solutions.
THREE STEPS TO RECOVERY
During a regular visit to her hairdresser, she mentioned her growing health problems and the response she received changed her life. It was at this point that she became hopeful, as she was told about the success of stem cell therapy.
Impressed with what she heard, (THE RECOVERY STEP 1) she began her own personal research about stem cells. She spoke to medical experts in the United States -- those involved in stem cell therapy and those who were not. Eventually she felt (STEP 2) she found the clinic that could help her.
She never (STEP 3) told her doctor where she had been or what procedure she had done. She needed to see for herself, without pressure from anyone, if the stem cell procedure helped. (Too many fools ask their know-nothing doctors about stem cells and they always deny any possible benefit---ALWAYS!)
She traveled to the clinic and found it clean, professional and very friendly. The doctors were knowledgeable, certified and kind. They did the stem cell treatment in one afternoon, and she traveled back to their hotel so she could rest -- something she commonly needed to do. Within a couple of hours she felt full of energy. The tired feeling she used to have was completely gone. She was frankly quite stunned herself with the sudden difference in the way she felt. Her grayish skin tone was now pink.
On the recommendation of the doctors at the clinic, she continued her normal routine of dialysis. Within a couple of weeks the levels of toxin in her blood had come down and soon Cass was cut back to getting dialysis twice a week. Over the next couple of months her blood toxin levels continued to improve and her doctor finally told her he couldn't completely understand it, but it looked as if her kidneys had begun working enough so she could stop dialysis temporarily to see how her kidneys performed.
Now off dialysis, her blood results continued to show improvement and the most magical day came when the doctor told her she could remove the catheter in her chest! It was a moment of celebration and triumph for her. It was a sign that her life was going to be normal again. And it was exactly five months to the day since she had received her stem cell treatment.
The very best news is with the passage of time her blood markers continue to improve, and most important of all, she continues to feel energetic and is able to again fully enjoy her life, her career, and her family.
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."
BODY DIES, STEM CELLS GO DORMANT AND SURVIVE FOR 2+ WEEKS
"Scientists around the world are shocked, but they shouldn't be," says Don Margolis
Under the direction of Fabrice Chrétien, in collaboration with Shahragim Tajbakhsh, researchers from the Institut Pasteur, the Université de Versailles Saint-Quentin-en-Yvelines, the Paris Public Hospital Network (AP-HP), and the CNRS have shown for the first time in humans and mice, the capacity of stem cells to adopt a dormant state when their environment becomes hostile, including several days after death. This ability to significantly reduce metabolic activity enables them to preserve their potential for cellular division, even after extended periods post mortem. After isolation, they can then be used to repair damaged organs or tissues. This discovery could lead to new therapeutic avenues for treating numerous diseases. The study is being published in the journal Nature communications.
Remarkably, skeletal muscle stem cells can survive for seventeen days in humans and sixteen days in mice, post mortem well beyond the 1-2 days currently thought. This discovery was made by researchers from the Institut Pasteur, the Université de Versailles Saint-Quentin-en-Yvelines, the Paris Public Hospital Network (AP-HP), and the CNRS under the direction of Professor Fabrice Chrétien*, in collaboration with a team led by Professor Shahragim Tajbakhsh**. The scientists were also able to show that these stem cells, once back in culture, retained their capacity to differentiate into perfectly functioning muscle cells.
In light of this astonishing result, scientists then sought to characterize these cells to understand how they survive in such adverse conditions. They observed that these cells enter a deeper state of quiescence, drastically lowering their metabolism. This so-called "dormant" state is a result of cellular organization that is stripped to the bare minimum: fewer mitochondria (cellular power plants using oxygen to produce energy in cells) and diminished stores of energy.
“We can compare this to pathological conditions where cells are severely deficient in resources, before regaining a normal cell cycle for regenerating damaged tissues and organs, explains Fabrice Chrétien. When muscle is in the acute phase of a lesion, the distribution of oxygen is highly disrupted. We have even observed that muscle stem cells in anoxia (totally deprived of oxygen) at 4°C have a better survival rate than those regularly exposed to ambient levels of oxygen.”
The team of Fabrice Chrétien then wondered if these results were consistent with other cell types. Tests were then done on stem cells taken from bone marrow where blood cells are produced. These cells remained viable for four days in post mortem mice models, and more importantly, they retained their capacity to reconstitute tissue after a bone marrow transplant.
This discovery could form the basis of a new source, and more importantly new methods of conservation, for stem cells used to treat a number of pathologies. This is the case for leukemia, for example, which requires a bone marrow transplant to restore a patient's blood and immune cells destroyed by chemotherapy and radiation. By harvesting stem cells from the bone marrow of consenting donors post mortem, doctors could address to a certain extent the shortage of tissues and cells. Although highly promising, this approach in the realm of cellular therapy still requires more testing and validation before it can be used in clinical applications. Nevertheless, it paves the way to investigate the viability of stem cells from all tissues and organs post mortem.
From Don: "Scientists around the world are shocked, but they shouldn't be, because Repair Stem Cells are created to divide, grow and cure, no matter what the obstacles. There are many many obstacles which can slow or stop that repair, but we are constantly finding ways around them. Now we know it will be possible in the future to collect stem cells (which are smart enough to go dormant) from a recently deceased body, test them, and use them to help another patient."
For all Stephanie Conner knew, her daughter would be born deaf, blind and with organ damage — the result of an often symptomless virus Stephanie had passed to her unborn child.
So when the girl, Madeline, was finally delivered at a Miami hospital, Stephanie and her husband considered it a major blessing that the girl’s biggest problem was her inability to hear.
Now, the LaBelle family hopes medical science will deliver another round of news verging on the miraculous: a stem cell cure (or partial cure) of Madeline’s hearing loss.
Madeline, who is nearly 2 years old, is the first person in the nation to take part in a new Food and Drug Administration-approved study of stem cell treatment of sensorineural hearing loss.
Children’s Memorial Hermann Hospital in Houston and California-based Cord Blood Registry will eventually enroll another nine children in this first phase of the study.
Unlike some advertised stem cell treatments that may cost patients tens of thousands of dollars — and, according to critics, are little more than quackery — the Conners paid nothing to take part and have been promised no specific results.
The process is simple: Doctors inject the children with stem cells from their own stored umbilical cords. Because it is the patients’ own blood, there is little chance the treatment will produce side effects.
In theory, the treatment will adjust patients’ immune systems to encourage their bodies to repair themselves. In truth, researchers have no idea if it will work.
Earlier Italian studies on mice concluded that stem cells may help the body repair damaged cells in the ear and restore some hearing in these types of cases, according to a 2008 published report in the University of South Florida journal Cell Transplantation.
The only other available treatments for Madeline’s kind of deafness are hearing aids and cochlear implants.
“I’m expecting really good results,” Stephanie Conner said. “I feel like God put this here in front of us for a reason.”
Madeline’s parents have a reason to be cautiously optimistic. Two of three preliminary tests after the treatment in January showed improvement in the girl’s hearing, the family said.
The Conners will head back to Texas in July, and again in January, to get a more detailed assessment of Madeline’s improvement.
This first phase will determine if the treatment is safe. Eventually, the study could span several years and include a much broader pool of participants.
For now, researchers involved with the study won’t release any of their early data, though they are candid about their expectations about outcomes for this part of the study.
“We have no idea,” said Dr. James Baumgartner, study sponsor and a neurosurgeon at Florida Hospital for Children in Orlando. “Hopefully there will be some children who respond so we can figure out timing and dosing.”
Prenatal testing gave the family an early indication there may be trouble.
Doctors told Stephanie Conner that she had been infected with the cytomegalovirus, known as CMV, which commonly causes no symptom.
The virus, which is spread by close contact with infected children or adults, is present in an estimated 50 percent to 80 percent of U.S. adults age 40 and younger, according to the Centers for Disease Control and Prevention.
But fetuses contracting the virus from their mothers have a one in five chance of developing serious health problems, the CDC notes. In Madeline’s case, doctors worried she would have brain damage, blindness, deafness and trouble with her heart and liver.
Stephanie and Joel braced for the worst.
Instead, Madeline’s biggest medical issue was her near total deafness. One eye showed signs of mild scarring, an indication of some potential damage. But today, the girl’s vision is expected to be normal.
She wears hearing aids in both ears. With them, and the constant instruction from her parents, she has been able to learn some speech.
“Sometimes I feel sorry for parents with ‘normal’ children because they don’t get to feel this kind of joy,” Stephanie Conner said.
No time to lose
Madeline’s involvement with the study involved a bit of little luck.
It started when Stephanie Conner randomly came across an article about parents who decided to freeze the blood contained in their children’s umbilical cords. The blood is rich in stem cells that have shown promise as a treatment tool in a wide range of medical conditions.
She opted for Cord Blood Registry, which she later discovered was involved with the hearing study with Children’s Memorial Hermann Hospital.
The study is limited to children between the ages of 6 weeks and 18 months, whose hearing loss is acquired and not related to a genetic defect. For the sake of consistency, they must also have stored umbilical cords with the Cord Blood Registry.
Sensorineural hearing loss stems from inner ear or brain damage, or a malfunction in the nerve pathways from the ear to the brain.
Children must have a certain level of hearing by the time they are almost 4 years old or they won’t be able to learn speech, said Linda Baumgartner, an auditory-verbal therapist in Orlando and study co-investigator.
“Hearing loss is a neurological emergency in an infant, if you want to develop spoken language,” said Baumgartner, who is married to Dr. James Baumgartner, the study sponsor. “Sound deprivation means that the door to that room is closing.”
Not for everyone
Despite this study, many in the medical community urge parents to take their time before opting to store umbilical cord blood for themselves.
The American Academy of Pediatrics recommends against it unless children fall into a high-risk health category. Instead, the organization believes parents should donate cord blood to storage banks and make it accessible to any family in need.
Private storage does not come cheap. Cord Blood Registry charges $2,070 for a one-time “processing/preparation fee” and $125 for the first year of storage.
For their part, the Conners are glad they did.
Madeline can now speak and is able to hear others speak, though it’s still unclear how much of this has to do with the treatment. Her parents say one of the biggest improvements is Madeline’s ability to more easily identify the source of sounds.
Delayed speech aside, she’s become quite the chatterbox and is able to speak a variety of words — Mamma, Dadda, Eli (her brother), various animals names, and so on — that her parents worried might take much longer for her to learn.
Whatever the outcome of Madeline’s treatment, it has provided hope for improvement that they did not have before.
Looking ahead, Joel Conner, Madeline’s father, said he has tried to temper his expectations.
“I’m just thankful she’s healthy,” Joel Conner said. “I think she’s going to be fine even if she doesn’t improve.”