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2012-15: USA Trillionaires Attempting to Match VesCell 2004-06
Baxter Begins Phase III Adult Stem Cell Trial For Chronic Cardiac Condition
(RTTNews.com) - Baxter International Inc. (BAX), valued at over THREE TRILLION DOLLARS, said it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia. Should it succeed, and one actuary has placed the odds at very close to 100%, they will have proven what VesCell proved in 2004-06 with capital of less than ONE ONE-MILLIONTH of Baxter's current value!
Chronic myocardial ischemia is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. VesCell (2005-2010) also treated over 200 non-ischemic patients with the same blood-derived stem cells.
Baxter said that the trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms, namely treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with chronic myocardial ischemia, as measured by a change in total exercise capacity at 12 months following treatment.
Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Exercise capacity (6 minute walk) was the key efficacy factor in the VesCell trial. Even better, that trial proved 100% safe, and none of the 500 no-hope heart patients treated after that trial was harmed by the patient's own blood-derived stem cells---still in use today and still no one can top them with published scientific data....no one.
Baxter noted that the trial is being initiated based on the phase II data, which indicated that injections of patients' own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.
Finally, I have long claimed that no serious heart stem cell treatment which can affect Big Medicine's profits will be approved in any developed country by 2020. Nothing here has changed that.
Don Margolis, Chairman
Repair Stem Cell Institute
Posted:
2/29/2012 6:35:54 PM by
Don Margolis | with
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(Reuters) - Treating stable heart patients with a handful of pills works just as well as propping open blocked heart arteries with a stent, U.S. researchers said on Monday, adding to evidence that less-invasive, less-costly drug treatment works as well as implanting a medical device in such patients.
Stents, made by companies such as Boston Scientific Corp, Abbott Laboratories and Medtronic Inc, are still the preferred treatment for opening up blocked heart arteries in patients rushed to the hospital with an acute heart attack.
But several studies have shown the heart devices are no better than drugs in patients with stable heart disease, in which heart arteries have narrowed and may be causing chest pain.
The latest analysis by Dr. Kathleen Stergiopoulous and Dr. David Brown of Stony Brook University Medical Center in New York, published in the Archives of Internal Medicine, attempts to knock down lingering arguments that earlier results were based on outdated technology.
Older analyses had included data from trials comparing drug treatments with balloon angioplasty, in which a balloon-tipped catheter is inserted and the balloon is inflated to open the narrowed passage.
For the latest so-called meta-analysis, the team pooled data only from newer studies that compared drug treatments with stents - a wire-mesh tube used to prop open the artery and prevent it from reclosing.
"The question was is there any benefit to stenting the blockages in these patients as an initial therapy procedure over treating them with optimal medical therapy and referring them to get a stent if necessary," Brown said in a telephone interview.
The analysis included results on more than 7,200 patients enrolled in eight studies between 1997 and 2005 comparing stents with medical therapy in stable heart patients with narrowed sections in their heart arteries.
"The result showed quite clearly there was no benefit of stenting as far as reducing death, heart attack, repeat procedures and even reducing symptomatic angina (chest pain)," Brown said.
He added that his analysis was the first to include only studies that used stents, and the results offered the most up-to-date comparison of the benefits of stenting procedures with modern medical therapy, which includes aspirin, a variety of blood pressure medicines such as beta-blockers, ACE-inhibitors or angiotensin receptor blockers and cholesterol-lowering statins.
'MISSES THE MARK'
Still, some doctors were not satisfied.
"The meta-analysis published in Archives of Internal Medicine uses old data, from 1995 to 2005, which offer little, if any, new information to guide clinical care," Dr. Theodore Bass, vice president of the Society for Cardiovascular Angiography and Interventions, a group of heart doctors that specialize in stenting procedures.
Bass said in an email that the study "misses the mark" on the quality-of-life concerns for patients and that stenting procedures helped relieve chest pain, or angina, in stable patients.
Dr. William Boden of the Samuel S. Stratton VA Medical Center in Albany, New York, who wrote a commentary in the journal, said relieving angina appeared to be the "last remaining sacred cow" for doctors who argue in favor of stents over drugs.
Boden is the lead author of a large study called COURAGE published in 2007 in the New England Journal of Medicine that was one of the first to challenge the value of stents and angioplasty over drug treatment.
In that study, patients with chest pain did get slightly more pain relief with stenting, but those benefits only lasted one to three years. "They are not durable," he said.
More recent studies could not show stents were any better than drugs at relieving angina, he contended.
Boden and Brown attribute the changes to improvements in medications, and given that most of them are generic, getting more doctors to choose drugs first could save a lot in health costs.
"In the context of controlling rising health care costs in the United States, this study suggests that up to 76 percent of patients with stable coronary artery disease could avoid percutaneous coronary intervention (such as stenting) altogether if treated with optimal medical therapy," Brown and Stergiopoulous wrote.
But fewer than half of Americans with stable coronary artery disease who get a stent have been treated with drugs first, Dr. Rita Redberg, editor of the Archives of Internal Medicine, said in an editorial.
She said more than 1 million stents were implanted each year to treat coronary artery disease in the hopes that stents would work better than drugs, despite ample evidence to the contrary.
Brown said part of the reason doctors ignored those studies was that there was a big financial incentive to use stents versus drugs.
"If I put a stent in you, I submit a bill for my fee, which could be $1,000 to $2,000. The hospital submits another bill for using the hospital, the stent, the equipment and nursing time," he said. The whole thing could add up to $20,000 or $30,000.
Brown therefore doubts the study will sway too many doctors, but said it may influence insurance companies.
"A few practitioners might change their behavior, but third-party payers will be influenced by it and they will start by making stricter criteria for reimbursing these procedures," he said.
(Reporting By Julie Steenhuysen; Editing by Peter Cooney)
Posted:
2/29/2012 6:28:24 PM by
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When standard USA medicine is useless and even top alternative therapies can't do the job, who ya gonna call? No, not even Ghostbusters can help! The busters of no-hope medical conditions are REPAIR STEM CELLS most of the time, and Embryonic Stem Cells NONE of the time.
James Mathis was born at the right time.
When the Rialto man had a medical problem the traditional approach couldn't fix, the cutting edge of medicine was ready to step in with a treatment that worked.
Mathis, 48, has known he has diabetes for 14 years. He's worked hard to manage it, but genetics are probably are not on his side.
Last year, a simple irritation on his right foot became a large festering wound that threatened his foot - and his life.
Perhaps the 6 foot 9 inch, 335-pound personal security agent toughed it out a little too long. If he had sought medical attention rapidly - instead of home remedies - perhaps things would not have gotten so bad.
When he showed up at the emergency room
at Arrowhead Regional Medical Center, there was little doubt what was needed - first, surgery to clear
off the dead tissue on his foot followed by treatments in the Colton hospital's hyperbaric chamber.
Hyperbaric units were originally developed to help divers overcome decompression sickness, "the bends,"
but have in recent years been used more to help heal problematic wounds, such as diabetic foot ulcers,
bone infections, radiation tissue damage (from cancer therapy) and compromised skin grafts.
Patients with these conditions are placed in hyperbaric chambers where they breathe 100 percent oxygen under pressure.
Largely because of the diabetic epidemic, hyperbaric wound treatment therapies are in great demand.
The large, gaping hole in the top of Mathis' foot showed significant improvement with the hyperbaric treatments -
the open area was gradually shrinking.
But then progress stopped - the wound wasn't shrinking anymore. A hole larger than a silver dollar wasn't changing.
After five months, doctors realized they had achieved whatever beneficial effects the hyperbaric chamber could provide - and their patient still had an open wound, which could become re-infected at any time.
But the timing was perfect. Dr. Vivian Davis and an Arrowhead Regional colleague, Dr. Farbi Hussain, were looking for patients for a clinical trial involving same person stem cell therapy. (Funny way to put it: "same person stem cells." But only in America. Since no one is allowed to publish a positive article about the cell which Big Medicin know will reduce its pprofits, and since Big Medicine runs the FDA and controls every major news medium in Amerika, the word "adult" is NOT ALLOWED in front of the words "stem cells" in a positive article!)
This relatively new treatment - already approved by the U.S. Food and Drug Administration - had been shown to lower the risk of extremity amputations in diabetic wounds.
Mathis become the first of 10 patients in a clinical trial from May to August.
With a grant from Arteriocyte, a medical device company, Arrowhead Regional acquired machines that "spin down" patients blood and bone marrow to isolate stem cells.
Stem cells are unspecialized cells that renew themselves through cell division. They can be induced to become specialized cells, where they are used to replace worn-out or damaged tissue.
With the aid of specialized centrifuges - and a proprietary medium developed by Arteriocyte - doctors were able to isolate Mathis' stem cells.
A "patch" containing the stem cells was applied directly to the patient's wound. The patch, also containing platelet rich plasma, is designed to stimulate healing of bone and soft tissue.
And the process worked. Mathis' wound closed.
Said Davis: "We have known for some time that stem cell therapy is promising. This study enabled us to see firsthand that we can realize recoveries we hadn't previously experienced."
Six of nine patients in the trial had wounds that closed completely - a rate of 67 percent - in an average of two months.
Three of the nine patients who had wounds that didn't completely close showed significant improvement, Davis said.
Source: National Institutes of Health
Posted:
2/25/2012 6:10:15 PM by
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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.”
Posted:
2/19/2012 12:28:30 PM by
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As comedian John Fugelsang recalls, all in life was dandy until one fateful day, at age 6, he noticed an odd motif in some photos: "In every family picture ... my mother was wearing a habit."
Last August, he tweeted his parents' unusual love story — with photos — on the one-year anniversary of his father's death. In a series of blurbs 140 characters or less, he tells it better than I ever could:
Fugelsang, who has hosted America's Funniest Home Videos and consulted for Rosie O'Donnell, among other things, explained more in an interview.
Not only had his mother, Peggy, joined a convent after an abusive childhood, taking the name Sister Damien. But his father, Jack, had become a Franciscan monk after high school. The two met in Brooklyn when Jack — or Brother Boniface — had become ill with tuberculosis.
"From all accounts I heard, he fell madly, desperately, insanely in love with this Southern nurse in a nun's habit that he knew he could never have, and had sworn to God he would never want to have," Fugelsang says.
Brother Boniface did the only thing he could do. He held a secret torch for Sister Damien for some 10 years. During that time, he expressed his love through platonic letters. She had been sent to Malawi to care for people with leprosy. And every week, he would write. He kept her — and all of the sisters — apprised of the latest: of L.B.J. and M.L.K. and everything else U.S.A.
Then, her father died. When she returned home to take care of her family, Brother Boniface found out and intercepted her — showing up at the hospital where she was working and professing his love. "She was appalled," says Fugelsang.
But eventually, Boniface won her over. They broke their religious vows and made new ones — to each other. As Fugelsang says, it was their first love and second marriage, the first being a marriage to God. They dropped their names and became Jack and Peggy again. They had kids and lived happily married for decades, from what Fugelsang recalls.
"I can honestly say that my father's love only grew as he got older and as they aged," says Fugelsang. "The romance didn't slow down for him at all. He was someone who was completely unable to separate his devotion to God from his devotion to his wife."
Well into his 60s, Jack's heart thumped at full force — emotionally and spiritually. But then, two heart attacks had doctors shaking their heads, saying there was nothing they could do.
"So he just began telling everyone that he wasn't going to die," says Fugelsang, "that he was going to live on because he was too in love. And he held on longer than any of the doctors thought he could."
A risky stem-cell treatment in Thailand afforded him a few more years.
"It was amazing seeing how even in the last days of his life, the love just got deeper and deeper. I have photos of him in his hospital bed looking at her with a kind of naked, calm love that I've seldom seen on a man's face."
Jack died in August 2010.
"You know, we live in a culture where men are not really celebrated for love," says Fugelsang. "And so for me, the most defining personal dynamic in my life has been watching a man madly in love with his wife."
"And now I'm going to be a dad for the first time," he continues. "[And] the fact of the matter is, my kid gets to grow up in this beautiful, complicated world because many years ago, some guy in Brooklyn chose love."
Last year, Fugelsang retold the story in tweets. Today, he's telling the unabridged version in a solo performance, Guilt: A Love Story, currently touring the country.
Posted:
2/15/2012 4:18:35 PM by
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Cora Beth Taylor walks a different road than most will ever travel. Her journey is filled with obstacles, heartbreak and triumph. Cora, William and Tate Taylor are triplets born premature. The brothers have never shown any signs of prematurity.
But Cora, at about a year old, started falling behind developmentally. By 18 months she had been diagnosed with
Cerebral Palsy.
Cora has never had any cognitive delays. She's a super-smart little gal but her muscles haven't developed properly. It's devastating; they just won't cooperate. Cora's parents, Kevin and Beth Taylor, have tried everything for their little girl; that is, everything available in the U.S. Last year, Piedmont Schools raised the money to help the Taylors take Cora to China for treatment, close to $50,000.
Research hospitals in China are using stem cells from donor umbilical cord blood to treat children with Cerebral Palsy. Beth Taylor says, "That was a difficult decision to make to take your child to a foreign country for medical treatments. Living in the US you feel like this is the best there is."
The Taylors spent 37 days in China. Cora Beth had eight stem cell transfusions. Through a spinal tap, doctors put the cells into her spinal column where they penetrate the blood-brain barrier and get to work.
Critics are quick to point out this area of regenerative medicine has largely unverified effectiveness. Results are often anecdotal and the
FDA is a long way from approving this type of experimental treatment for America.
Though the Taylors are convinced and here's why. Beth Taylor said, "Within the first couple of weeks we could see changes. We could see definite improvements in strength and balance."
Cora had never been able to do a sit-up in her life ever; she did her first in China. Nine-year-old Cora remembers, "The thing that I was most happy about accomplishing was a sit up. Because I'd tried to do a sit up before going to China but I just couldn't do it."
Now, Cora Beth can do 20. The most notable change has been Cora's walk. This third-grader had never gone to school without her walker. Today she walks the halls without it; she hasn't used it in months.
She recently competed in a beauty pageant in her hometown of Piedmont, without the help of her walker as well. Cora says, "So, I'm really excited. I don't think there's anything that I couldn't accomplish."
Doctors say Cora’s stem cells will continue to mature over the next few years. For her, there are many milestones ahead. In the US,
Duke University is studying stem cell treatments for children with Cerebral Palsy. Right now they don't have FDA clearance to use donor stem-cells.
Experts say treatment similar to Cora Beth's Chinese therapy is years away in the U.S.
Posted:
2/14/2012 2:57:58 PM by
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Pro/Am ballroom dancer and orthodontist, Dr. Janet Vaughan, is once again slated to compete on the professional dance circuit with her current professional partner, Mr. Eddie Stutts (Professional 10-Dance World Champion) following a successful stem cell procedure on her knee in Central America..
From 2007-2009, Dr. Vaughan partnered with World Champion Tony Dovolani and competed extensively in the U.S., winning a National Reserve Pro/Am Rhythm title. Tony Dovolani is best known for his appearances on ABC's hit reality series, "Dancing with the Stars", and has teamed up with Chynna Phillips, Wendy Williams, Audrina Partridge, Kate Gosselin, Kathy Ireland, Susan Lucci, Jane Seymour and other celebrities on the show.
Dr. Vaughan and Mr. Stutts are slated to compete in the Heritage Classic Dancesport Championships in Asheville, North Carolina next month. This will be the first time Dr. Vaughan has been able to compete since 2010 when she sustained a dancing related knee injury.
Dr. Vaughan also suffered from chronic neck pain resulting from injuries sustained in a car crash twenty years ago. Her neck injury culminated in a natural fusion of the c5-c6 vertebrae, scoliosis and extreme pain when her neck slipped out of alignment.
In an attempt to repair her knee and get her dancing career back on track, Dr. Vaughan decided to undergo stem cell therapy. "I was basically removed from competitive dance work because I could not rise or squat without extreme pain. I had also resigned myself to enduring chronic neck pain from my past accident and painful hand joints due to generalized arthritis," said Dr. Vaughan.
Dr. Vaughan 's knee was treated with stem cells that were harvested from her own adipose (fat) tissue.
The fat tissue sample is collected via mini-liposuction, which is performed by a certified plastic surgeon under light, general anesthesia. Mesenchymal stem cells and T regulatory cells reside within this tissue.
Adipose-derived cells are then separated from the fat. This entire process is subjected to stringent quality control. Before they can be administered back into the patient, these adipose-derived stem cells are tested for quality, bacterial contamination (aerobic and anaerobic) and endotoxin.
The adipose-derived stem cells are administered by a highly-qualified physician into the affected joint(s) (intra-articular injection) and intravenously (IV).
"It's taken about 6 months but I am amazed at the results I've gotten with my knee. Even my neck is better. I used to spend almost $1,000 per month on a neuromuscular massage therapist but I haven't needed any neuromuscular massages for the past 6 months. I wasn't counting on that. Even my doctors say that the dense scar tissue in my neck has changed in texture from grizzly to smooth, supple tissue," exclaimed Dr. Vaughan.
She continued, "I just danced 6 hours in Houston preparing for the upcoming competition in Asheville and my knee isn't even sore."
Dr. Vaughan is planning to return for a follow-up treatment this summer.
Posted:
2/3/2012 4:36:10 PM by
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Children’s Memorial Hermann Hospital (Texas), CBR launch US FDA approved stem cells study to treat sensorineural hearing loss with patient's own stored Umbilical Cord Stem Cells.
Children’s Memorial Hermann Hospital and Cord Blood Registry (CBR) are launching the first US FDA-approved, phase I safety study on the use of cord blood stem cells to treat children with sensorineural hearing loss.
The study, which will use patients’ stem cells from their own stored umbilical cord blood, is the first-of-its-kind, and has the potential to restore hearing. This follows evidence from published laboratory studies that cord blood helps repair damaged organs in the inner ear.
The year-long study will follow 10 children, ages 6 weeks to 18 months, who have sustained post-birth hearing loss. Children who are deaf as a result of a genetic anomaly or syndrome are not eligible. To ensure consistency in cord blood stem cell processing, storage, and release for infusion, CBR is the only stem cell bank providing clients for the study.
“Children only have 18 months to acquire language skills and, if a child does not hear well, they will not acquire the language skills to speak normally,” said James Baumgartner, MD, sponsor of the study and guest research collaborator at The University of Texas Health Science Centre at Houston (UTHealth) Medical School.
Parents will be interviewed by phone to determine eligibility of their children for the study. Those who meet the criteria will be admitted to Children’s Memorial Hermann Hospital to undergo a series of blood tests, hearing and speech tests, and an MRI that will view the tracts that send signals from the inner ear to the brain.
The Principal Investigator is Samer Fakhri, MD, surgeon at Memorial Hermann-Texas Medical Centre and associate professor and program director in the Department of Otorhinolaryngology – Head & Neck Surgery at UTHealth. Linda Baumgartner, MS, CCC-SLP, Auditory-Verbal Therapist, is a co-investigator.
“Currently, the only treatment options for sensorineural hearing loss are hearing aids or cochlear implants,” Dr Fakhri said. “We hope that this study will open avenues to additional treatment options for hearing loss in children.”
Researchers will obtain and process the patients’ stored cord blood for treatment. The cells then will be given to the patients via IV infusion, and patients will be observed for several hours in the hospital.
Patients will return to the hospital to repeat all tests except the MRI at one month and one year, and all tests with an MRI at six months.
“This study is exciting because it might offer a non-surgical option for some children with profound loss,” Linda Baumgartner said. “More importantly, this is the first treatment with the potential to restore normal hearing.”
Since more infants are surviving premature birth, physicians and researchers are seeing a rising number of very young children with significant hearing loss. About 15 per cent of children in the US also suffer from low-frequency or high-frequency hearing loss that can impact the child’s speech, language, and social development and can increase their risk of developing learning disabilities, according to Dr Fakhri.
“We share Dr Fakhri’s and Dr Baumgartner’s passion and commitment to understanding more about the potential applications of cord blood to help repair nerve tissue,” said Heather Brown, vice president of scientific and medical affairs at CBR. “It is exciting to be at the forefront of research to match children who have cord blood stored, with this team of groundbreaking doctors studying autologous stem cell therapies for hearing loss.”
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1/16/2012 1:56:34 PM by
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Surgeons in Sweden have replaced the cancerous windpipe of a Maryland man with one made in a laboratory and seeded with the man’s cells.
Thomas Grosse/Harvard Bioscience
A trachea made from plastic, above, and seeded with stem cells was successfully implanted in a Baltimore man in Sweden.
The windpipe, or trachea, made from minuscule plastic fibers and covered instem cells taken from the man’s bone marrow, was implanted in November. The patient, Christopher Lyles, 30, whose tracheal cancer had progressed to the point where it was considered inoperable, arrived home in Baltimore on Wednesday. It was the second procedure of its kind and the first for an American.
“I’m feeling good,” Mr. Lyles said in a telephone interview from his home, where he was playing with his 4-year-old daughter. “I’m just thankful for a second chance at life.” He said he hoped to resume his job, as an electrical engineer with the Department of Defense, as soon as he regained full strength.
“He went home in very good shape,” said Dr. Paolo Macchiarini, director of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institute in Stockholm.
Dr. Macchiarini is a leader in the field of tissue engineering, in which the goal is to produce replacement tissues and organs outside the body. Research in the field has undergone a resurgence in recent years because of advances in understanding stem cells — undifferentiated cells that can proliferate and be induced to become cells of a specific type of tissue.
“What we did is surgically remove his malignant tumor,” Dr. Macchiarini said. “Then we replaced the trachea with this tissue-engineered scaffold.” The Y-shaped scaffold, fashioned from nano-size fibers of a type of plastic called PET that is commonly used in soda bottles, was seeded with stem cells from Mr. Lyles’s bone marrow. It was then placed in a bioreactor — a shoebox-size container holding the stem cells in solution — and rotated like a rotisserie chicken to allow the cells to soak in.
After two days, it was installed in Mr. Lyles during an elaborate operation in which it was sutured to his throat and lungs. All told, the treatment cost about $450,000, Mr. Lyles said.
David Green, the president of Harvard Bioscience, the Massachusetts company that made the bioreactor, said that once the cells were inside the scaffold, they began to grow and divide and produce cartilage. “After two or three days, I think you can realistically call it tissue,” he said.
While special compounds called transcription factors were used to help force the stem cells to differentiate into trachea-specific cells, Dr. Macchiarini said that once the windpipe was implanted the cells continued to grow and differentiate, presumably because of chemical signals produced by the body. “We’re using the human body as a bioreactor to promote regeneration,” he said.
Because Mr. Lyles’s own cells were used, there is no need for drugs to prevent his body from rejecting the windpipe, which is a common problem in transplants using donated organs.
But Alan O. Trounson, the president of the California Institute for Regenerative Medicine, said that although rejection would not be a problem, the body responds to any foreign object, often by trying to encapsulate it. While he described Dr. Macchiarini’s work as “terrific,” he said he was not sure how long such a transplant could be expected to last.
“It looks very functional at this stage,” Dr. Trounson said. “But there’s going to be a reaction of some kind.” More work will probably be needed to develop scaffold materials that are optimized to reduce the response, he added.
Dr. Macchiarini has performed a dozen trachea transplants since 2008, but the first 10 used organs from cadavers in which all the living cells were removed, leaving behind a natural scaffold of cartilage. Donated tracheas are rare, however, and are never a perfect fit. In Mr. Lyle’s case, and in the case of an Eritrean man who received a similar transplant last June and is doing well, the synthetic scaffold is made using CT scans of the existing trachea to ensure it matches precisely.
The field of tissue engineering has gone through periods of boom and bust, as predictions that companies would one day be fabricating hearts and other complex organs have not come close to fruition. But there have been successes with simpler tissues like skin — a few products are on the market — and with another organ, the bladder, which, like the trachea, is relatively simple. Researchers at Wake Forest University have successfully built tissue-engineered bladders and transplanted them into patients with
spina bifida.
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1/13/2012 3:13:57 PM by
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UNIV. HAWAII Assoc. Professor: "I'm Learning How To Live"
HONOLULU -- About a year ago, KITV first told the story of a University of Hawaii associate professor diagnosed with three rare autoimmune diseases.
Cristy Kessler was living with pain every day and was, in her words, "preparing to die." But after undergoing experimental stem cell treatment overseas, she's now learning how to live.
Just a mere nine months ago, a walk down the block wasn't possible.
"The pain was so intense, I was on morphine and vicadin around the clock, everyday," said Kessler.
Although the 40-year-old didn't look sick, her body was basically attacking itself from three different autoimmune diseases: Scleroderma, Vasculitis, and Akylosing Spondylitis.
Stem cell transplant was an option to stop the diseases progress, but it's not yet approved by the FDA and not covered by insurance in the United States. Kessler finally found help overseas.
Dr. Zafer Gulbas of Anadolou Hospital in Istanbul, Turkey performed the stem cell transplant in March 2010. It was a grueling 2-month long procedure of blood tests, intense chemotherapy and isolation.
"Her disease was in the early phase of the scleroderma. Because of the transplantation, it helped her," said Gulbas.
Gulbas said treating the disease early ensures better success with stem cell transplant. Kessler still takes antibiotics and with an immune system like that of a newborn baby, she has to be extra careful not to get sick. But she's no longer on prescription pain medications.
Stem cell transplant is still considered experimental - it's long term effects not yet known. But for people like Kessler, it's given her a new life right now.
"I really want to enjoy the music and look like a fool dancing and sound terrible when I sing, but have fun doing it and not be in pain," said Kessler.
She is now preparing to go back to work full time in a couple of months.
"I got a second chance. I got a do-over and I need to make the best of it and I need to pay it forward," said Kessler.
Donations from friends and co-workers and a hefty loan helped pay for Kessler's stem cell procedure.
Posted:
1/12/2012 3:03:39 PM by
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