Is Alzheimer’s treatment of injecting stem cells into the brain a breakthrough or quackery? – The Keene Sentinel
IRVINE, Calif. More than eight years after he realized something was wrong, after, as he described it, My brain went ... whats the word? ... Foggy, Jack Sage finally said after several seconds of silently coaxing his synapses to fire.
More than eight years after his brain went foggy, four years after he was diagnosed with Alzheimers disease and two years since he began an innovative and extremely invasive therapy, Sage said he is being flooded by memories that seem new, or, at the very least, feel easier to retrieve. His daughter, Kate, thought Sage had suddenly begun to open up about his past because he knew his time was growing short.
He should not know who I am at this point, Kate said.
His doctor, Christopher Duma, hopes Jack Sage goes down in history as the one-man turning point in the treatment of Alzheimers disease, while others are skeptical about what Duma has done to Sages brain. Everyone agrees that Alzheimers disease is an exploding problem.
According to the Alzheimers Association, more than 5 million Americans are living with the disease, and 1 in 3 seniors die with Alzheimers or another form of dementia.
On a cool recent night, Sage, a handsome, fit, 82-year-old, sat next to his wife Gloria talking about his children (It is significant that Sage remembers their names James, 46, Kate, 50, and Kelly, 56), recalling when he and Gloria moved into the Newport Beach house with a view of the Pacific Ocean (1990), laughing about their first date at the Bel-Air Country Club (1979), recounting his years as a labor negotiator and executive for Del Monte, Allied Chemical and Continental Airlines (1970s and 60s) and going all the way back to the jack hammering he did in the nickel mines in the mid-1950s in Northern Ontario, Canada.
At this point in his illness, his doctor said he should be having more trouble remembering the perilous tunnels of the Sudbury nickel mine.
You drill into the granite, Sage said. You put dynamite in the rock. You dynamite it. Then you shovel out whats left.
And mining, you might say, is what is happening in Jack Sages brain.
Sages series of recollections, including his exploits on the golf course in Indian Wells where he has a second home and plays several days a week flashbacks representing the three main components of long-term memory: semantic (recalling the meaning of words), episodic (recalling autobiographic milestones) and procedural (recalling how to accomplish tasks) prompted a grin from Duma, the brain surgeon who, for $10,000 per treatment and without insurance coverage, cut a hole in the back of Sages head and injected a stem cell serum that had been sucked out of Sages love handles.
Is this the Alzheimers breakthrough the world has been waiting for? Or, is this unproven medical procedure what University of Minnesota bioethicist Leigh Turner calls quackery and flimflam? Is this an unsafe, money-grab it is being conducted outside the approval process of the Food and Drug Administration preying on the most vulnerable among us?
Turner has written extensively and critically about the Cell Surgical Network (CSN), for which Duma, whose home hospital is Hoag in Newport Beach, is listed as a network physician. The CSN promotes the stem cell revolution, which its literature claims, is an appropriate treatment for people suffering from a variety of inflammatory and degenerative conditions in other words, for cancer, diabetes, bad knees and hips as well as multiple uses in cosmetic surgery.
You dont just start dumping things into peoples brains, Turner said. The problem is people may spend a lot of money and find there is no benefit. He (Duma) is exposing people to serious harm. Fat cells dont belong in peoples brains.
Sage is the first patient in Phase I of a clinical study officially called Intracerebroventricular injection of autologous abdominal fat-derived, non-genetically altered stem cells. Sage was the first Alzheimers patient anywhere to have his own liposuctioned cells injected directly into his brain. He has received eight injections (about two months apart) since November 2014.
Duma quickly offers a qualifier. It is far too early to tell if what he has done to Sage will indeed change the world. He said Sage and, later, 19 other patients have not been harmed by the procedure, and that safety is the only criteria in Phase I. Whether the treatment is effective is a question for Phase II, for which Duma is hoping to attract private funding. Also, he wrote a letter to the national Alzheimers Association asking for $700,000 to continue his work. He was instructed to apply officially later this year. If he gets the grant, the fees for his patients would be waived.
Early in the process, Duma is excited by Sages results.
Sages most recent cognition scores have risen from 45 on the 100-point Memory Performance Index in March 2015 to 54 in September 2015. The volume of his hippocampus the memory center of the brain has grown from the fifth percentile before his first treatment to the 28th percentile after his fourth treatment to the 48th percentile after his eighth treatment.
My golf game is getting better, said Sage, who, heart permitting, plays several times per week. Sages brain isnt his only problem. He has a long history of heart ailments that have required the insertion of 12 stents to keep his arteries open.
You cant make a global conclusion based on one patient, but its a huge turning point, Duma said with the confidence of someone who probes brains for a living.
Duma is somewhat of a maverick in the medical world, a brain surgeon who regularly shuns a scalpel for the gamma knife, a futuristic laser for removing brain tumors. He is known outside the operating room for playing keyboards in bands that specialize in 1970s-era covers of groups such as Genesis, Yes and Emerson, Lake and Palmer. As a child, he was a classmate of John F. Kennedy Jr. at The Browning School in New York City. We called him John John, Duma said.
Duma realizes he will face opposition to his stem cell/brain injection therapy. But, as in all breakthroughs, someone has to be first.
I could have harmed people, he said. I took an enormous leap.
Not much hope
Alzheimers patients dont get better.
They get diagnosed, lose their dignity and die.
The speed at which death occurs is the only variable.
In the depressing world of Alzheimers treatment, Sage and Duma represent equal parts hope and skepticism. The Orange County Register contacted universities and research centers across the country, including Stanford, Harvard, Duke, Florida International, UC Davis, and some of the interview requests were denied while other calls were not returned. Very few medical experts want to talk about the combination of stem cells and Alzheimers disease, apparently because they know so little about it.
An Alzheimers patient improving because of therapy? Im hopeful its true. Im hopeful its true for all patients, said Joshua Grill, the co-director of the Memory Impairments Neurological Disorders (MIND) institute at UC Irvine. We are in dire need.
But, Grill continued, One study does not a revolution make. Ive never read anything about this (Dumas work), and I dont know what science is behind it.
Dean Hartley, Director of Science Initiatives at the Alzheimers Association, knew about Dumas work.
This is new territory, Hartley said. But with one patient, No, you cannot say this is a game-changer.
Hartley said many studies fail at the Phase II level, where more and more people are exposed to the therapy.
Still, Hartley said Dumas work is encouraging.
We want to see things like this happen, Hartley said.
Its not as if Duma is conducting his research in secret. He spoke about his study in public forums twice last year Sept. 28 at the Congress of Neurological Surgeons in San Diego, and Oct. 1 at the International Society for Cellular Therapy in Memphis.
Duma said he is nearly finished writing a paper about his work that he hopes will be published in a peer-reviewed journal.
THE STEM CELL IDEA
In 1993, Christopher Duma was working at Good Samaritan Hospital in Los Angeles when he and his colleagues began injecting stem cells into the brains of patients with Parkinsons disease. They were making some progress, he said, but politics intervened. Some of the stem cells they were using came from aborted fetuses. Pressure from anti-abortion groups shut that program down.
Fifteen years later, Duma was assisting plastic surgeon Michael Elam on a face-lift on a Parkinsons patient when Elam said, We need to talk about stem cells.
Elam introduced Duma to Drs. Mark Berman and Elliot Lander, the founders of the Cell Surgical Network.
Berman and Lander had been separating stem cells from fat by using a centrifuge (which they own the patent for) and injecting them into knees and hips and other places where injuries had occurred. Their work had passed an Institutional Review Board after 1,524 patients were treated with no adverse effects, Berman said.
If you want to repair an injury, Berman said, the best tissue is the stem cell.
In 2013, Duma suggested a new target for stem cell therapy: the brain.
Duma, with Berman, Lander and Elam as co-authors, tried to begin a study of brain/stem cell injections. But their first attempt at Institutional Review Board approval was denied because they hadnt done animal testing. So they got Dr. Oleg Kopyov at Cal State Northridge to conduct tests on rats.
With the help of Kopyovs work, Duma got Institutional Review Board approval. They chose not to take the usual next step FDA approval.
The Institutional Review Board was expecting us to go through the FDA, Lander said. But there are hundreds of obstructions. The FDA approval process usually takes between eight and 12 years, according to the online journal Medscape.com.
Duma said stem cells present a quandary for the FDA because stem cells are not a drug, and theyre not food. Clinics that take stem cells out of the body and put them back in without additives argue that they are exempt from FDA mandates.
We have been harvesting fat from abdomens and putting them in the brain during brain surgeries since the 1920s, Duma said. We do it nearly on every case for pituitary tumors, acoustic and skull base tumors and for conditions of spinal fluid leakage ... since the 1920s. If the FDA ruled that harvested autologous fat cannot be used in the brain, then it would change nearly a century of neurosurgical standard of care.
Someday, Duma said he hopes the FDA will recognize his work.
The work cant wait, he said.
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Is Alzheimer's treatment of injecting stem cells into the brain a breakthrough or quackery? - The Keene Sentinel