How researchers in Vail are pursuing breakthroughs to help injuries heal faster and some day slow down the way … – The Denver Post

VAIL Hallways at the world-famous Steadman Clinic are lined with framed, autographed jerseys of star athletes who have had surgery here, including John Elway, Mario Lemieux and Alex Rodriguez.

The clinic and its associated Steadman Philippon Research Institute (SPRI) attract world-class talent from all fields including U2 drummer Larry Mullen Jr., who joined the institutes board after he was a patient here but perhaps its top recruit was a renowned scientist researching ways to help injuries heal faster and slow down the way our bodies age.

Were trying to develop the iPhone 9 of medicine, said Dr. Johnny Huard, chief scientific officer and director of the institutes Center for Regenerative Sports Medicine. Your iPhone 6 and 7 are great, its doing everything you want, but youre looking on the web at what the iPhone 8s going to do. We want to have surgeons here doing surgery on our best football, hockey, basketball players, and instead of losing a year to heal, can we heal them in six months? Three months? Would that be great?

Joe Amon, The Denver Post

The field is called biologics, and its transforming orthopedics by using cells that heal produced in the patients body in concentrated injections that can hasten tissue repair directly at the site of the injury. Huard is leading cutting-edge research into stem cells and platelet-rich plasma (PRP) therapy that he believes will some day delay age-related diseases and cut the recovery time from serious injuries, such as to the knee, in half.

Stem cells are undifferentiated cells that can become specialized cells muscle, bone, cartilage to help repair tissue. Platelets carry proteins that help in the healing process. The breakthroughs Huard and his colleagues are pursuing hold exciting promise for weekend warriors as well as for star athletes.

I dont think we can reverse aging, but I think we can age better and recover from injury better, said Dr. Marc Philippon, managing partner of the Steadman Clinic and co-chairman of the research institute. As a surgeon my biggest challenge is, if I cut on you theres always that healing phase. We want to recover faster. But the most important thing is prevention of injury. If your cells are aging better, youll have less injury. The way I look at it, thats going to put us out of business, but thats OK. Its a good way to go out of business.

A world-class scientist, Huard discovered muscle-derived stem cells in 1998. Before joining SPRI two years ago he was the director of the Stem Cell Research Center at the University of Pittsburgh.Researchers here believe injections of stem cells and PRP can help delay or prevent the need for joint replacements, and at the adjacent clinic they can test their theories in clinical trials. They have shown in animal studies that young stem cells can rejuvenate old stem cells.

To that end Huard advocates passionately that when a child is born, stem cells from the umbilical cord should be harvested and frozen at minus-80 degrees Fahrenheit. As bodies age, stem cells diminish in number and vitality, but they can be preserved in suspended animation while frozen. Those cells later can be thawed and reintroduced into the body as younger and more robust stem cells than the ones that have aged in the patient, performing like a fountain of youth.

Thats the best gift you can give to that baby, said Huard, a French Canadian with a playful wit. Its the best gift you can give to that mother, too, because that (umbilical cord) is part of her, too. Its not only part of the baby. Can you believe the impact of that?

Stem cells, aging and exercise

Because stem cells can develop into every cell type in the body, researchers believe they can be used to hasten repair of nerves, bone and muscle. Bone marrow transplants are the most common form of stem cell therapy currently in use, but stem cells may be useful in fighting neurodegenerative diseases and other conditions.

We can use them to repair bone, cartilage, the heart, the bladder, Huard said. We have clinical trials now ongoing for bladder and the heart.

Imagine a Broncos running back blowing out his anterior cruciate ligament in training camp but being able to return to the field during the regular season. Huardforesees that day, as well as a time when patients whose stem cells were harvested and stored at birth will be able to have them injected into their knees decades later after ACL repair, for example, which theoretically could allow the person to recover much faster.

If I harvest stem cells from your muscle today, lets say I find 100 stem cells, but if I do the same thing 30 years ago I may have gotten 10,000, Huard said. Not only that, but the 100 stem cells you have are tired. They have been dividing and trying to repair your muscle.

When one of Huards children was born 17 years ago and it came time for Huard to cut the umbilical cord, he asked the nurse what they were going to do with it.

My wife said, Can you stop being a scientist and be my husband for a minute here? Huard tells the story with amusement, but he is passionate that umbilical cord stem cells should be saved.

I tell people, No more flowers, just freeze the stem cells from that newborn, Huard said. Thats the best gift you can give to that kid.

In the meantime, Huard believes exercise remains the best anti-aging mitigation we have. Beyond the benefits already well known, he is convinced exercise increases the production of stem cells and delays the aging process.Researchers found that mice that run on treadmills heal significantly faster than sedentary mice. Mice who exercised also had a better survival rate after being injected with cancer cells than those that were sedentary.

Huardbelieves exercise helps the brain as well as the heart in ways that might not be fully understood but might have implications for the prevention or delay of dementia and Alzheimers.

Stem cells come from blood vessels, Huard said. What can we do to increase the number of blood vessels? If we can do that, then we can probably improve tissue repair. If you exercise, you increase the number of blood vessels in your tissues.

Platelet-rich plasma therapy

PRP therapy is already in widespread use, not just in elite athletes but in recreational athletes as well. Sometimes it works well, and sometimes it doesnt work at all. Huard is trying to find out why.

Platelets in the blood carry proteins called growth factors that help the body repair injured tissue. In PRP therapy, a patients blood is removed and spun in an centrifuge or filtered to separate platelets. Then the platelet-rich plasma is injected into the site of an injury with hopes of speeding the healing process.

When you injure something, you bleed, Philippon said in his office with a view of Vails ski trails. Some of the first elements going there are your platelets, and theres a reason for that. Platelets have the growth factors, also what we call the chemotactic factors, to attract whats needed (to heal).

Philippon has used PRP to hasten healing of hip tendons in football players, for example.

What we found was that those I injected with PRP early recovered faster, Philippon said. We have that data here. We know, for a tendon injury, PRP is a great therapy.

Huard had elbow surgery last year after snapping a tendon off the bone in a ski accident I like to go fast, he said with a grin and Steadman surgeon Peter Millett asked Huard if he wanted a PRP injection in hopes of hastening recovery.

I said, Of course! You know what? I never wore a sling, Huard said. The week after, I was running. Three weeks after, I was back skiing.

But did the PRP help?

I dont know, Huard said.

So Huard is studying the success rate of PRP therapy in patients who receive it after surgery at the Steadman Clinic. When Philippon uses PRP on a patient, for example, he will set aside a fraction of that PRP and give it to Huard to analyze in the lab. Huard will catalog the different growth factors in each sample and then wait to see how the patients respond.

After this Im going to go back to Marc and say: Which patient worked? Which one was your best patient? Huard said. If he tells me patient No. 24 and 32 and 48, Im going to go back and try to see what those three patients PRP had in common in terms of growth factors.

Then Huard will be able to better advise surgeons before using PRP.

Lets say we find when IGF1 (insulin growth factor one) is high in your blood, PRP always works, Huard said. You know what Im going to give to those surgeons? Im going to say, Before you give PRP, take a blood draw, we go in the lab, test for IGF1, and if IGF1 is high, 95 percent chance PRP is going to help. But another patient, if IGF1 is not high, Based on our tests, I dont think PRP is going to help.

Another thing we found in PRP, it is a mixed bag. You have good things in PRP but you have bad things, too. So were doing science where Im going to take PRP, Im going to take out the bad guys.

As with stem cells, Huard foresees a day when a young patients PRP can be frozen and used decades later to delay aging, administered in conjunction with stem cell injections to work in synergy.

I think the two can be combined somehow, Huard said. They are different, but the stem-cell therapy and the PRP somehow can be together. If I have your PRP from 20 years ago and I have your stem cells from 20 years ago, I can make a very nice mixture, inject this into you. Sometimes adding one thing to another, biologically, it equals not two but three.

Having his laboratory in the same building as the Steadman Clinic, which has eight surgeons on staff, is a boon for Huard in his research. He takes ideas to them and vice versa.

I dont do science just to do science, he said. I do science to improve quality of life, and I think I can make a major contribution in the field. If you delay aging by 10 years, you delay all those age-related disorders by 10 years. The implications for health care is amazing.

Biologics: Using tools produced by a patients body such as stem cells and platelet-rich plasma (PRP) to help the patient heal faster and better.

Regenerative medicine: This and tissue engineering are promising treatment approaches that can enhance or promote musculoskeletal tissue healing and regeneration following surgery or injection therapy. Biological treatments such as growth factor supplementation, PRP and bone marrow concentrate have been shown to improve patient function and quality of life.

Platelet-rich plasma: A biologic treatment that is produced by concentrating the patients own blood to yield a high platelet count. Platelets are important blood components that secrete hundreds to thousands of biological factors that initiate musculoskeletal tissue healing and regeneration.

Stem cells: Stem cells have the ability to transform into specific musculoskeletal tissue cells. These types of cells also secrete biological factors that initiate musculoskeletal tissue healing and regeneration. There are several forms of stem cells, such as muscle-derived stem cells, bone marrow-derived stem cells, adipose-derived stem cells and others.

John Meyer, The Denver Post

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How researchers in Vail are pursuing breakthroughs to help injuries heal faster and some day slow down the way ... - The Denver Post

THON by the numbers: An anaylsis of the work done and the funds raised – The Daily Collegian Online

With THON merely hours away, lets take a look at the massive event by the numbers. One thing is certain: the statistics are remarkable.

Two-thirds of all money raised since THONs inception in 1977 has been raised in the past 10 years.

Since 2007, THON has raised over $93 million dollars for Four Diamonds, according to the Four Diamonds annual financial reports.

Four Diamonds provides financial and medical assistance to children with pediatric cancer and their families, specifically for care and treatment not covered by insurance or other means as well as additional expenses that disrupt the welfare of the children.

According to Four Diamonds website, 100 percent of all patients bills are covered.

However, the Four Diamonds does not just cover the treatment bills for kids with pediatric cancer. Four Diamonds also enables specialty care providers to be made exclusively available to patients and their families. These specialty care providers offer psychological care, nutritional care, social work such as transportation assistance, musical therapy to help cope with hospital settings and pastoral care for spiritual and religious needs.

Based on the information aggregated from Four Diamonds annual financial and impact reports, Four Diamonds on average takes in and provides funding for treatment for about 93 new patients per year and provides funding for treatment for about 558 patients per year total.

The funding Four Diamonds has received has allowed them to fund researchers and research initiatives for fighting and treating cancer. Specifically, funds from THON have allowed for the creation of stem cell transplant clinic, a pediatric cancer experimental therapeutics research program.

Gil Pak, the Operations Director for the Hershey Childrens Hospital, said the fundraising from

THON is one of the primary contributors to research funding.

The original goal of the Millards, when they founded Four Diamonds was to assist families, but with the fundraising success of THON and Mini-THONs we can go beyond that and invest in research, Pak said. Providing assistance to families will always be the main goal, but now we can go beyond just helping families and help find a cure.

From 2007 to 2014 the funds raised by THON increased steadily. In 2007 THON raised $4,497,001, but by 2012 THON was raising eight figure sums and in 2014 THON raised a record breaking $13.3 million in funds.

However, the last couple years saw a dip in funds raised by THON.

Despite Four Diamonds receiving record of $20 million in 2015, THON actually experienced a slight drop in fundraising from the previous year.

In 2015 THON raised $12,732,897, about $60 thousand less than 2014 when THON raised a record breaking $13,336,675.

Funds raised for the Four Diamonds by THON 2016, $10,262,256 was the lowest since THON 2011 when it raised, $9,266,841.

The cutbacks on canning in 2015 to 2016 (THON 2016 but the 2015-2016 Annual Financial Report), following the death of Vitalya Tally Sepot, a sophomore at Penn State, in September of 2015, may have been one of the factors that led to THON raising less money that year.

Sepots death sent shockwaves through the Penn State community and caused THON to evaluate the safety of canning trips. Several canning trips were cancelled by THON organizers due to concerns about less than ideal weather or other safety concerns.

Other factors could be at play as well. The drop in funds raised could also be that it is just difficult for those canning and participating in other fundraising events to continue raising money that will top the previous years eight figure sums. One student quoted in a previous report by The Daily Collegian said that the number of people canning in the same areas made it more competitive.

However, as reported previously by The Daily Collegian, many of those participating THON do not see topping the previous year's funds as important as how much the funds are benefiting kids with childhood cancer.

Even though funds raised by THON have decreased over the last couple years, the funds raised by Mini-THONs have steadily increased each year.

In 2007, Mini-THONs which are as events similar to THON that are held in elementary schools, middle schools, high schools and colleges, raised $624,246, but by 2016 though less than a decade later funds the funds raised were $5,497,215, about 8.8 times the funds raised by Mini-THONs in 2007.

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THON by the numbers: An anaylsis of the work done and the funds raised - The Daily Collegian Online

Mayo researcher Abba Zubair is sending stem cells for study on the … – Florida Times-Union

As a boy growing up in Nigeria, Abba Zubair dreamed of becoming an astronaut.

But as he prepared to apply to college, an adviser told him to find a different path.

He said it may be a long time before Nigeria sends rockets and astronauts into space, so I should consider something more practical, Zubair saud.

He decided to become a physician, and is currently the medical and scientific director of the Cell Therapy Laboratory at the Mayo Clinic in Jacksonville. And while hell almost certainly never get to make a journey outside the Earths atmosphere himself, if the weather stays good Saturday hell be sending a payload into space.

A SpaceX Falcon 9 rocket is scheduled to launch at 10:01 a.m. Saturday from the Kennedy Space Center on a cargo delivery mission to the International Space Station. Among the cargo it will be carrying are several samples of donated adult stem cells from Zubairs research lab.

Zubair believes adult stem cells, extracted from bone marrow, are the future of regenerative medicine. Currently at the Mayo Clinic in Jacksonville they are being used in clinical trials to treat knee injuries and transplanted lungs.

But a big problem with using stem cells to treat illnesses is that it may require up to 200 million cells to treat a human being and the cells take a long time to reproduce. Based on studies using simulators on Earth, Zubair believes that the stem cells will more quickly mass produce in microgravity.

Thats the hypothesis hell be testing as the stem cells from his lab spend a month aboard the space station. Astronauts will conduct experiments measuring changes in the cells. They will then be returned on an unmanned rocket and Zubair will continue to study them in his lab.

We want to understand the process by which stem cells divide so we can grow them at a faster rate and also so we can suppress them when treating cancer, he said.

Zubair became interested in the idea of sending stem cells into space four years ago, when he learned of a request for proposals that involved medicine and outer space. Hes been trying to arrange to send stem cells into space for three years.

In May 2015, he sent stem cells to the edge of space as a hot-air balloon carried a capsule filled with cells from his lab to about 100,000 feet then dropped the capsule. The idea was to test how the cells handled re-entry into the Earths atmosphere.

It turned out well, he said. The cells were alive and functioning.

Zubair was supported in that effort as he is being supported in sending cells to the space station by the Center for Applied Spacee Technology. Its chief executive is Larry Harvey, a retired Navy pilot and former astronaut candidate who lives in Orange Park.

While stem cells have myriad potential medical applications, one that particularly interests Zubair is the use of them in treating stroke patients. Its a personal cause to Zubair, whose mother died of a stroke in 1997.

Weve shown that an infusion of stem cells at the site of stroke improves the inflammation and also secretes factors for the regeneration of neurons and blood vessels, he said.

Zubair hasnt entirely given up on his old dream of being an astronaut. Hes applied for the civilian astronaut program. But he doesnt expect that to happen.

Im not sure I made the cut, he said. I just wanted to apply.

And he realizes what a long, strange trip hes made.

I have come so far from Africa to here, he said, and now Im sending stem cells into space.

Charlie Patton: (904) 359-4413

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Mayo researcher Abba Zubair is sending stem cells for study on the ... - Florida Times-Union

A 60-Year-Old Man With Progressive Anemia While Receiving Checkpoint Blockade Therapy for Relapsed Myelofibrosis – Cancer Network

A 60-year-old man with a history of coronary artery disease and JAK2 V617Fpositive polycythemia vera presented to our bone marrow transplantation clinic with progressive fatigue, splenomegaly, and cytopenias. He had been in good health up until 14 years prior, when he was found to have polycythemia on routine blood work. He was treated with low-dose aspirin and serial phlebotomies for many years without complications. However, he eventually developed worsening thrombocytosis that required treatment with hydroxyurea and anagrelide. A bone marrow biopsy was performed; this demonstrated postpolycythemia vera myelofibrosis, World Health Organization grade 3/3, with 80% cellularity and 2% blasts. Cytogenetics revealed deletion of chromosome 20q. JAK2 V617F mutation testing was performed, and the patient was found to harbor this mutation. Treatment with ruxolitinib was initiated, which within 2 months resulted in resolution of his splenomegaly and improvement in his anemia. However, 1 year later, he developed progressive fatigue, splenomegaly, and worsening anemia, and he was referred for evaluation for hematopoietic stem cell transplantation.

On presentation to our clinic, he complained of significant fatigue and abdominal fullness. Laboratory analysis revealed a white blood cell count of 9,100/L, a hemoglobin level of 9.6 g/dL, and a platelet count of 271,000/L. His spleen measured 22 cm longitudinally on cross-sectional CT imaging. Human leukocyte antigen (HLA) typing was performed on the patient and his siblings, but this did not identify any matched related donors. A search was initiated with the National Marrow Donor Program, but no matched unrelated donors were identified. His two daughters then underwent HLA typing, and both were found to be haploidentical.

He subsequently underwent a haploidentical hematopoietic transplantation with fludarabine/cyclophosphamide/total body irradiation conditioning, followed by posttransplantation cyclophosphamide. His posttransplant course was complicated by polyarticular inflammatory arthritis. Unfortunately, 30 days after transplantation, autologous hematopoietic stem cell recovery was identified through testing for chimerism. Sixty days after his first transplant, he underwent a second haploidentical transplantation utilizing his other daughters stem cells. He first received conditioning with fludarabine and alemtuzumab and again received posttransplantation cyclophosphamide. His posttransplant course was complicated by BK virusassociated cystitis and mild grade 1 cutaneous graft-vs-host disease (GVHD), treated with topical corticosteroids. He continued to have cytopenias, and a bone marrow biopsy (Figure 1) performed 90 days after his second transplant showed persistent myelofibrosis, with deletion 20q on cytogenetics in 3 of 20 metaphase cells. Despite tapering of immunosuppression, he developed progressive loss of donor myeloid chimerism. However, he retained donor T-cell chimerism (> 90%).

Due to progressive disease, he was offered enrollment in a clinical trial utilizing the cytotoxic T-lymphocyteassociated antigen 4 (CTLA-4) checkpoint inhibitor ipilimumab for patients with relapsed hematologic malignancies following allogeneic stem cell transplantation (ClinicalTrials.gov identifier: NCT01822509). On day 395 after his second transplant, he began treatment with ipilimumab at 5 mg/kg. He tolerated the first infusion well, without toxicity. His hemoglobin level was 9.5 g/dL. Twenty-one days later he was given his second dose of ipilimumab; his hemoglobin level was 8.6 g/dL. Fifteen days after his second dose of ipilimumab, his hemoglobin level dropped to 7.7 g/dL and his reticulocyte count increased to 10.1%; his white blood cell and platelet counts remained stable. His lactate dehydrogenase (LDH), total bilirubin, and indirect bilirubin levels rose to 449 U/L, 2.33 mg/dL, and 2.13 mg/dL, respectively. Two days later, his hemoglobin dropped furtherto 7.0 g/dL.

A. Bone marrow biopsy

B. Peripheral blood flow cytometry for CD55 and CD59

C. Direct Coombs test

D. Further donor chimerism studies

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A 60-Year-Old Man With Progressive Anemia While Receiving Checkpoint Blockade Therapy for Relapsed Myelofibrosis - Cancer Network

Dr. Oz takes on those bogus for-profit stem cell clinics–and cuts them to shreds – Chicago Tribune

The undercover investigation youre about to see today is going to make you really angry, because were exposing the worst kind of scam one that takes advantage of those most vulnerable, stealing not just their money, but their hope, their dignity.

Thats how Dr. Mehmet Oz introduces a series of segments scheduled to run on his daytime television program Tuesday. His quarry: those for-profit clinics offering supposed stem cell treatments for an implausible host of diseases unproven, unlikelyand very expensive cures.

We reported on this noisome corner of medical pseudo-sciencelast year, outlining theabsence of scientific support for their treatmentand their intensive marketing pitches to hopeful patients. We reported that in a survey of stem cell tourism, stem cell scientist Paul Knoepfler of UC Davis and bioethicist Leigh Turner of the University of Minnesotaidentified 570 clinicsaround the U.S. offering stem cell interventions. Scores were concentrated in such hotspots as Beverly Hills, Phoenixand New York. Many were offering unproven therapies featuring the termstem cell as a marketing veneer.

Dr. Ozs investigation of these clinics is a worthy addition to public awareness. Its must-viewing for patients and families desperate enough to contemplate turning to such clinics for succor, and for state and federal regulators and law enforcement agencies that should be riding herd on thembut have almost universally given them a pass. Oz calls on the Food and Drug Administration and other regulators to step in and stop this now, thats how bad its become.

Weve been critical of Dr. Oz in the past for purveying untested medical nostrums, as have many other critics. But his investigation of the stem cell clinics is a model of public service. He musters his entire arsenal of crowd-pleasing techniques his forceful, impassioneddelivery, his cultivated aura of medical authority, and his credibility with his audience to the best purpose.

The investigation is the product of the shows so-calledmedical unit and its chief of staff, Michael Crupain, a medical doctor and public health specialist who was hired from Consumer Reports about a year and a half ago. At one point during his research for the program Crupain dialed in to a webinar in which prospective patients were recruited by a clinic. It was like watching someone sell a time-share, he told me an observation that made it into the show.

The three segments, which take up about half of Tuesdays scheduled program, include undercover visits to clinics in New York by Elizabeth Leamy, a reporter on the program, along with a former patient. At one point we see a clinic employee claim that hestreated 44 patients for multiple sclerosis, and every single patient had vast improvement. The investigators are pitched $15,000 treatments and encouraged to spread it out on their credit cards. (No insurer will cover these untested and unproven therapies.) One promoter seen on tape acknowledges to the undercover team, We dont know the exact mechanism of everything we do, but counselsthem, We just know that it works, we use it. If it works and its safe [and] its reasonable in cost, you know, why not?

Why not, indeed? Because the targets of these pitches are at the end of their rope, vulnerable to scamsters,and often have to make immense sacrifices to pay the fees. Doctors and others can prey on their vulnerability, Oz observes.

Oz displays a list of the conditions the clinics claim to treat joint pain, autism, Parkinsons, Alzheimers, stroke, emphysema, and blindness, among many others. He explains that its impossible for a one-size-fits-all treatment to cure them all: It defies basic medical know-how, which means they are not telling us the truth. He lucidly describes their supposed technique, which involves extracting stem cells from the patients by liposuction, separating the stem cells by centrifuge and treating them with some sort of enzyme, then reinjecting them in the patients body and waiting for the concoction to do its magic.

He offers a withering assessment of doctors who claim to be engaged in clinical trials of stem cell treatments butask you to give money upfront and mortgage your house and borrow fromyour friends credit cards thats not how medicine should be practiced.

Oz is assisted by talk show host and multiple sclerosis patient Montel Williams and Sally Temple, a stem cell scientistwho is president of theInternational Society for Stem Cell Research. Temple explains that real research into stem cell treatments takes years and aims to develop treatments that can receive FDA approval. She quite properly underscoresthe dangerto legitimate research posed by bogus clinics offering medically dubious treatments.

Theyre saying they can cure a whole host of diseases, and we know they cant, she says. We are really concerned that its going to undermine the genuinely good work thats being done.

Crupain considers the stem cell investigation to be Dr. Oz at his best. Hes right.

Keep up to date with Michael Hiltzik. Follow@hiltzikmon Twitter, see hisFacebook page, or emailmichael.hiltzik@latimes.com.

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Dr. Oz takes on those bogus for-profit stem cell clinics--and cuts them to shreds - Chicago Tribune

Neuroscience: New nerves for old – Nature.com

Greg Iger/Keck Medicine of USC

Kristopher Boesen, who broke his neck in a car accident, regained the ability to move his arms and hands after his spinal cord was injected with stem cells.

Two years after having a stroke at 31, Sonia Olea Coontz remained partially paralysed on her right side. She could barely move her arm, had slurred speech and needed a wheelchair to get around. In 2013, Coontz enrolled in a small clinical trial. The day after a doctor injected stem cells around the site of her stroke, she was able to lift her arm up over her head and speak clearly. Now she no longer uses a wheelchair and, at 36, is pregnant with her first child.

Coontz is one of stem-cell therapy's miracle patients, says Gary Steinberg, chair of neurosurgery at Stanford School of Medicine in California, and Coontz's doctor. Conventional wisdom said that her response was impossible: the neural circuits damaged by the stroke were dead. Most neuroscientists believed that the window for functional recovery extends to only six months after the injury.

Stem-cell therapies have shown great promise in the repair of brain and spinal injuries in animals. But animal models often behave differently from humans nervous-system injuries in rats, for example, heal more readily than they do in people. Clinical trial results have been mixed. Interesting signals from small trials have faded away in larger ones. There are plenty of unknowns: which stem cells are the right ones to use, what the cells are doing when they work and how soon after an injury they can be used.

The field is still young. Stem cells are poorly understood, and so is what happens after a spinal-cord injury or stroke. Yet, there are success stories, such as Coontz's, which seem to show that therapy using the right sort of stem cell can lead to functional improvements when tried in the right patients and at the right time following an injury. Researchers are fired up to determine whether stem-cell therapies can help people who are paralysed to regain some speech and motor control and if so, what exactly is going on.

Neurologists seeking functional restoration are up against the limited ability of the human central nervous system to heal. The biology of the brain and spinal cord seems to work against neuroregeneration, possibly because overgrowth of nerves could lead to faulty connections in the finely patterned architecture of the brain and spine, says Mark Tuszynski, a neurologist at the University of California, San Diego. Local chemical signals in the central nervous system tamp down growth. Over time, scarring develops, which prevents the injury from spreading, but also keeps cells from entering the site.

It's really hard to fix the biology, says Charles Yu Liu, a neurosurgeon and director of the University of Southern California Neurorestoration Center in Los Angeles. Stem cells seem to promise a workaround.

So far, neural regeneration cell therapy has had only anecdotal success, leaving investors and patients disappointed. In people with Parkinson's disease, for example, neurosurgeons replaced dead and dying dopamine-producing neurons with fetal neurons. Although initial results were promising, in larger studies, patients reported involuntary movements. Another effort tried treating people who'd had a stroke with cells derived from tumours; the results were mixed, and researchers were uneasy about the cells' cancerous source.

In recent years, researchers have had success with stem cells coaxed to develop into particular cell types, such as neural support cells. Tuszynski has showed how well stem cells can work at least, in animal models1. His group implanted neural stem cells derived from human fetal tissue into rats with severe spinal-cord injuries. Seven weeks later, the cells had bridged the gap where the spinal cord had been cut and the animals were able to walk again. The cells used in the study were manufactured by Neuralstem of Rockville, Maryland. The group has shown that other kinds of stem cell, including those derived from adult tissue, also work. Tuszynski has seen similar results in a rat spinal-cord-injury model, using neural stem cells made from the tissues of a healthy 86-year-old volunteer2.

Mark Tuszynski/Ken Kadoya/Ref. 3

Regeneration of axons (red) beyond implanted neural progenitor cells (green) in a rat with a spinal injury.

But animal studies are also making it clear that simply regrowing the connective wiring of the nervous system to bridge damaged areas is not enough, says Zhigang He, who studies neural repair at the Harvard Stem Cell Institute in Cambridge, Massachusetts. No matter what the animal model is, he says, the axons don't always grow into the right places. It's not enough to have a nerve, that nerve must become part of a functional circuit.

There is growing evidence that besides becoming replacement nerves, stem cells perform other functions they also seem to generate a supportive milieu that may encourage the natural recovery process or prevent further damage after an injury. Many types of neural stem cell secrete a mix of molecules that unlock suppressed growth pathways in nerves. Earlier this year, Tuszynski reported that any sort of spinal-cord stem cell, whether derived from adult tissues or embryos, from humans, rats or mice, could trigger native neural regeneration in rats3. But his success in rats has not yet translated into clinical trials. More work is needed, Tuszynski says, to determine which type of cell will work best for which particular injury.

For people who have had a stroke or spinal-cord injury, physical therapy is currently the best hope for recovery in the weeks and months after the injury. The brain is plastic and can co-opt other circuits and pathways to compensate for damage and to restore function. Once the inflammation ebbs and the brain adjusts, people can start to regain function. But the window of opportunity is short. Most people don't make functional gains after six months.

That timeline is why the remarkable recovery enjoyed by Coontz and other patients with chronic stroke in the same clinical trial is so surprising, says Steinberg. This changes our whole notion of recovery, he says. There were 18 people in the trial Coontz took part in, and all were treated using stem cells manufactured by SanBio of Mountain View, California. The company's cells are bone-marrow-derived mesenchymal stem cells. The cells are treated with a DNA fragment that is transiently expressed in them, and causes changes in their protein-expression patterns. In animal studies, these cells promote the migration and growth of native neural stem cells, among other effects.

The trial, which was designed to look at safety as well as efficacy, recruited patients after an ischaemic stroke. During this kind of stroke, a clot cuts off the blood supply to part of the brain, causing significant damage. Patients in the trial had all had ischaemic strokes deep in the brain 736 months earlier past the 6-month window for significant recovery. Each patient was injected with either 2.5 million, 5 million or 10 million of SanBio's cells4. Steinberg has followed participants for 24 months; an interim study at 12 months reported that most patients showed functional improvements. Some, like Coontz, achieved almost complete recovery.

What is not clear, however, is what the stem-cell injections do in the brain. In animal studies, the SanBio cells do not turn into neurons, but seem to send supporting signals to native cells in the brain. Indeed, preclinical research shows that the cells do not integrate into the brain most die after 12 months. Instead, the cells seem to secrete growth factors that encourage the formation of new neurons and blood vessels, and foster connections called synapses between neurons. And in rats, the nerve-cell connections that extended from one side of the brain to the other, as well as into the spinal cord, lasted, even though the injected cells did not4.

But these mechanisms are not sufficient to explain Coontz's overnight restoration of function, says Steinberg. He is entertaining several hypotheses, including that the needle used to deliver the cells may have had some effect. One week after treatment, we saw abnormalities in the premotor cortex that went away after one month, he says. The size of these microlesions was strongly correlated with recovery at 12 months. A similar effect can happen when electrodes are implanted in the brains of people with Parkinson's, although this deep-brain stimulation quietens tremors for only a short time. The people who'd had a stroke had a lasting recovery, suggesting that both the needle and the stem cells may have played a part.

The SanBio trial was small, and did not have a placebo control; the company is now recruiting for a larger phase II trial. Of the 156 participants that will be recruited, two-thirds will have cells injected the others will have a sham surgery. Even the trial surgeons, including Steinberg, will not know who is getting which treatment. The main outcome measure will be whether patients' motor-skill scores improve on a test called the Fugl-Meyer Motor scale six months after treatment. Participants will be monitored for at least 12 months, and will also be evaluated with tests that look for changes in gait and dexterity. Meanwhile, Steinberg plans to study microlesions in animal models of stroke to determine whether they do have a role in recovery.

An ongoing clinical trial evaluating escalating doses of neural stem cells in patients with acute spinal-cord injuries is also looking promising. Asterias Biotherapeutics of Fremont, California, coaxes the cells to develop into progenitors of oligodendrocytes, a type of support cell that's found in the brain and spinal cord and that creates a protective insulation for neuronal axons.

The trial tests the safety and efficacy of administering these cells to people with recent cervical, or neck-level, spinal-cord injury. Interim results for patients who had received the two lower doses were presented at the International Spinal Cord Society meeting in September. After 90 days, 4 patients who received 10 million cells showed improved motor function; a fifth patient had not reached the 90-day mark yet. At one year, the three patients receiving a lower dose of two million cells showed measurable improvement in motor skills.

These cells were initially developed by Geron, a biotechnology company that has since moved away from regenerative medicine. Before spinning out Asterias in 2013, Geron had run a safety trial of the cells in people with a chronic lower-back injury. No issues were identified, and the US Food and Drug Administration agreed to let the company test the cells in patients who'd been recently injured. Asterias focused the current trial on patients with cervical injuries because these are closer to the brain, so new nerve cells have a shorter distance to grow to gain functional improvements. People with severe cervical spine injuries are typically paralysed below the level of the damage. The company's hope is to restore arm and hand function for people with such injuries, potentially making a tremendous difference to a person's independence and quality of life.

Asterias seems to have realized this hope in at least one patient who received one of the higher doses. Kristopher Boesen, who is 21, has had a dramatic recovery. In March, Boesen's car fishtailed in a rainstorm; he hit a telephone pole and broke his neck. About a month later, Boesen was still paralysed below the injury, and his neurological improvements seemed to have plateaued. His doctors at a trauma centre in Bakersfield, California, were in touch with Liu, who is an investigator in the Asterias trial. As soon as he was stable, Boesen travelled to Los Angeles to join the trial.

Liu injected Boesen's spinal cord with Asterias's cells in April. Two days later, Boesen started to move his hands, and in the summer, he regained the ability to move the toes on one foot.

Asterias Biotherapeutics

A surgeon prepares to inject stem cells to treat a spinal injury as part of Asterias's clinical trial.

Liu is excited about Boesen's response. He was looking at being quadriplegic, and now he's able to write, lift some weights with his hands, and use his phone, says Liu. For somebody to improve like this is highly unusual I want to be jumping out of my shoes. But Liu cautions that this is still a small trial, and that Boesen's response is just one anecdotal report. Until the results are borne out in a large, placebo-controlled clinical trial, Liu will remain earthbound.

The trial is currently recruiting between 5 and 8 patients for another cohort that will receive a doubled dose of 20 million cells. As the trial goes on, Asterias hopes to find clues about the underlying mechanism. We're looking at changes in the anatomy of the injury, says the company's chief scientific officer, Jane Lebkowski. She says that there is some evidence that axons have traversed the injury site in patients who have recovered function. Preclinical work suggests that the cells might be sending growth-encouraging chemical signals to the native tissue. And, as support cells, the astrocytes may also be preventing more neurons from dying in the aftermath of the acute spinal injury.

Not all clinical trials have performed so well. The SanBio and Asterias results are positive signals in a sea of negative or mixed trials. For example, StemCells of Newark, California, terminated its phase II trial of stem cells for the treatment of spinal-cord injury in May, and shortly afterwards announced that it will restructure its business. The company declined to comment for this article.

Physicians such as Liu and Steinberg temper their public enthusiasm about stem-cell therapies, so as not to give false hope to desperate patients. People with paralysing injuries or those who have a neurodegenerative disease are easy marks for unscrupulous stem-cell clinics, whose therapies are not only unproven, but also come with risks.

Patients say, 'Go ahead, doc, you can't make me any worse,' says Keith Tansey, a neurologist and researcher at the Methodist Rehabilitation Center in Jackson, Mississippi, and president-elect of the American Spinal Injury Association. Unfortunately, that is not the case. Cell therapies given at a clinic, outside the context of a clinical trial, can lead to chronic pain, take away what little function a patient has left and render a patient ineligible for future studies, says Tansey. He has seen the consequences in his clinical practice. I treated a kid who had two different tumours in his spinal cord from two different individuals' cells, he says.

Many unanswered questions remain about whether stem cells can heal the central nervous system in people, and how they might do it. Researchers also don't know what cells are the best to use. Is it enough for them to grow into supportive cells that send friendly growth signals, or is it better that they grow into replacement neurons? The answer is likely to differ depending on the site and nature of the disease or injury. If the stem cells are producing supportive factors that encourage growth and repair, it might be possible, says He, to discern what these are and give them directly to patients. But biologists are not yet close to deciphering the recipe for such a cocktail.

Every time we get an experiment done we realize it's more complex than we thought it would be.

Tansey agrees that there are many unknowns and these seem to be multiplying. Every time we get an experiment done we realize it's more complex than we thought it would be, he says. Tansey thinks that the best way to resolve such uncertainties is with carefully regulated clinical trials. Rat models will only tell us so much the human nervous system is much larger and is wired differently. If stem cells help patients such as Coontz and Boesen to regain their speech and give them greater independence without adverse effects, then it makes sense to continue, he says, even without knowing all the details of how they work.

Until these positive, but small, results are replicated in larger, controlled clinical trials, neurologists are containing their optimism. I'd like to hear of any clinical trial that has more than an anecdotal benefit, says Tansey. And Liu is anticipating the day when he won't need to control his elation. In a few years, perhaps there will be a genuine opportunity to jump for joy.

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Regenerative Biologics Institute (RBI) Offers Next Generation Regenerative Treatments Including Stem Cell Therapy … – PR Web (press release)

Vero Beach, FL (PRWEB) February 08, 2017

The Regenerative Biologics Institute, or RBI, has opened a state-of-the-art facility in Vero Beach, FL to offer innovative regenerative therapies to patients on the Treasure Coast and throughout Florida. RBI is the first of its kind center of excellence in the area that specializes in minimally-invasive regenerative therapies and is complete with a dedicated biologics laboratory. RBI also utilizes advanced image guidance technology including ultrasound and even live x-ray for precise delivery of therapeutics into certain areas of the body like the spine. Regenerative Medicine is an innovative approach that utilizes a patients own natural regenerative ability in the form of stem cells and platelets to treat degenerative conditions, sports injuries and more. The field has been recognized worldwide as one that offers the potential to dramatically impact patient care in the 21st century.

Millions of Americans suffer from chronic pain or sustain injuries during their lives that can often be debilitating and limit their daily activities. RBIs stem cell therapy and platelet rich plasma therapy (PRP), treatments may offer new hope to these patients since they are among the few therapies that offer the true promise of treating the underlying causes of degenerative conditions instead of just treating the symptoms. The ultimate goal of using regenerative therapies is reduce pain, rebuild healthier tissue and restore more normal tissue function allowing patients to live and age better.

We are very excited about opening an RBI facility in Vero Beach, said Jason Griffeth, RBIs Managing Director. Ive had the opportunity to travel the globe learning, teaching and developing regenerative medicine techniques for nearly 15 years so it is exciting to bring this expertise to my home town. Our goal is to establish one of the premier regenerative medicine clinics in Florida and to help patients feel & function better using their own bodies natural healing ability.

RBI treats a wide variety of conditions including back/spine pain, sports related injuries, arthritis and more. RBIs therapies use the bodys natural healing capability to stimulate and enhance healing without side effects. All RBIs treatments are non-surgical and minimally invasive so they require little down time post-procedure, allowing patients to get back to their active lifestyle quickly. The entire treatment can be completed within a couple hours and patients return home the very same day.

For stem cell therapy treatments, a small tissue sample is taken from a patient then processed to isolate and concentrate millions of regenerative cells. These cells are then combined with bioactive platelets and injected precisely into an area of need such as a degenerative disc or arthritic joint.

Platelet Rich Plasma, commonly known as PRP, is derived from a patients own blood sample and is composed of highly concentrated platelets and growth factors. PRP has been shown to stimulate healing in soft tissues by supplying growth factors, cytokines and other bioactive proteins. PRP can also act as a biological scaffold for stem cell treatments which can potentially enhance healing even further.

Once available only to professional athletes, RBI aims to bring these innovative therapies to all patients that can benefit from them. If you would like to talk to one of our experienced team members to see if you might benefit from RBIs regenerative therapies, please call us at 772-492-6973, email us at info(at)rbistemcell(dot)com or visit our website at http://www.rbistemcell.com.

About RBIs Team

RBIs unique model is to combine experts and leading scientists from the regenerative medicine field with clinicians that are trained in precise injection techniques. Our Managing Director, Jason Griffeth, has been in the regenerative medicine field for nearly 15 years and has directed the science & development of a number of pioneering regenerative therapies worldwide. He was worked with clinicians at leading research institutions to develop some of the most advanced regenerative medicine treatment protocols and stem cell isolation protocols available.

RBIs Medical Director, Dr. Brett Haake, is a Board Certified Anesthesiologist that has trained with leading stem cell scientists and clinicians. His fervent interest in the field of regenerative medicine is due to his lifelong participation in athletics and service in the military. He joined RBI in order to be on the cutting edge of immunomodulatory therapies including stem cell and PRP treatments. As a Specialist in Anesthesiology, Dr. Haake is a highly trained physician that draws on his extensive knowledge in physiology, pharmacology and diseases to guide his treatment techniques.

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Regenerative Biologics Institute (RBI) Offers Next Generation Regenerative Treatments Including Stem Cell Therapy ... - PR Web (press release)

Conference looks at the medical possibilies of using adult stem cells – Florida Times-Union

In 2014, when Springer Publications published Stem Cells in Aesthetic Procedures, the first book ever published on the subject, Jacksonville physician Lewis Obi contributed a chapter, Specialized Stem Cell Fat Transfer to Face.

At places like the Mayo Clinic, researchers have been looking at the possibilities that stem cells could someday help repair damaged organs.

But Obi, a veteran plastic surgeon, already has been using stem cells, harvested from a patients own fat, in a number of procedures in recent years. He has become an ardent champion of the potential stem cells have in regenerative medicine. While stem cells extracted from bone marrow have been used in the past, Obi said there are actually more stem cells in fat than in bone marrow and they are easier to harvest

The current use of stem cells and the potential of stem cells will be the subject of a two day symposium by the Cell Surgical Network of Florida, an organization Obi founded. The symposium will be held Thursday and Friday at Memorial Hospital.

Presenters during the conference include three Jacksonville physicians, Obi, orthopedic surgeon David Heekin and anesthesiologist and pain management specialisit Orlando Florette. Heekin will talk about the orthopedic uses of stem cells and Florette will talk about the use of stem cells in pain management.

Another presenter will be Hee Young Lee, a Korean physician who invented Maxstem, a totally enclosed system which processes adult fat into large numbers of viable stem cells. Obi has used these cells in both his plastic surgery practice as well as in regenerative medicine.

Stuart Williams, a researcher with the University of Louisville, will discuss issues with the Food and Drug Administration, which has been reluctant to approve the use of stem cells to treat many conditions that stem cell advocates believe could be treated effectively with stem cells.

Mark Berman, co-author of the 2015 book The Stem Cell Revolution and co-founder of the Cell Surgical Network, the nations largest stem cell network, is scheduled to appear via Skype to talk about using stem cells to mitigate the effects of concussions.

Thursday will feature asesssions on preparing and storing stem cells and bioprinting. Friday will feature 12 presentations, the last being a panel discussion by nine faculty members.

For more about the conference and about the Cell Surgical Network of Florida, go to http://www.stemcellsurgeryflorida.com.

Charlie Patton: (904) 359-4413

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Conference looks at the medical possibilies of using adult stem cells - Florida Times-Union

The next weapon against brain cancer may be human skin – The Verge

Human skin can be morphed into genetically modified, cancer-killing brain stem cells, according to a new study. This latest advance has only been tested in mice but eventually, its possible that it could be translated into a personalized treatment for people with a deadly form of brain cancer.

The study builds on an earlier discovery that brain stem cells have a weird affinity for cancers. So researchers, led by Shawn Hingtgen, a professor at University of North Carolina at Chapel Hill, created genetically engineered brain stem cells out of human skin. Then they armed the stem cells with drugs to squirt directly onto the tumors of mice that had been given a human form of brain cancer. The treatment shrank the tumors and extended survival of the mice, according to results recently published in the journal Science Translational Medicine.

The treatment shrank the tumors and extended survival

Usually we think about stem cell therapy in the context of rebuilding or regrowing a broken body part like a spinal cord. But if they could be modified to become cancer-fighting homing missiles, it would give patients with a deadly and incurable brain cancer called glioblastoma a better chance at survival. Glioblastomas typically affect adults, and are highly fatal because they send out a web of cancerous threads. Even when the main mass is removed, those threads remain despite chemotherapy and radiation treatment. This cancer has caused a number of high-profile deaths including Senator Edward (Ted) Kennedy in 2009, and possibly Beau Biden more recently. Approximately 12,000 new cases of glioblastoma are estimated to be diagnosed in 2017.

We really have no drugs, no new treatment options in years to even decades, Hingtgen says. [We] just really want to create new therapy that can stand a chance against this disease.

But theres a problem: brain stem cells arent exactly easy to get. Brain stem cells, more properly known as neural stem cells, hang out in the walls of the brains irrigation canals areas filled with cerebrospinal fluid, called ventricles. They generate the cells of the nervous system, like neurons and glial cells, throughout our lives.

They could be modified to become cancer-fighting homing missiles

A research group at the City of Hope in California conducted a clinical trial to make sure it was safe to treat glioblastoma patients with genetically engineered neural stem cells. But they used a neural stem cell line that theyd obtained from fetal tissue. Since the stem cells werent the patients own, people who were genetically more likely to reject the cells couldnt receive the treatment at all. For the people who could, treatment with the neural stem cells turned out to be relatively safe although at this phase of clinical trials, it hasnt been particularly effective.

More personalized treatments have been held up by the challenge of getting enough stem cells out of the patients own brains, which is virtually impossible, says stem cell scientist Frank Marini at the Wake Forest School of Medicine, who was not involved in this study. You cant really generate a bank of neural stem cells from anybody because you have to go in and resect the brain.

So instead, Hingtgen and his colleagues figured out a way to generate neural stem cells from skin which in the future, could let them make neural stem cells personalized to each patient. For this study, though, Hingtgen and his colleagues extracted the skin cells from chunks of human flesh leftover as surgical waste. That really is the magic piece here, Marini says. Now, all of a sudden we have a neural stem cell that can be used as a tumor-homing vehicle.

That really is the magic piece here.

Using a disarmed virus to infect the cells with a cocktail of new genes, the researchers morphed the skin cells into something in between a skin cell and a neural stem cell. People have turned skin cells back into a more generalized type of stem cell before. But then turning those basic stem cells into stem cells for a certain organ like the brain takes another couple of steps, which takes more time. Thats something that people with glioblastoma dont have.

The breakthrough here is that Hingtgens team figured out how to go straight from skin cells to something resembling a neural stem cell in just four days. The researchers then genetically engineered these induced neural stem cells to arm them with one of two different weapons: One group was equipped with an enzyme that could convert an anti-fungal drug into chemotherapy, right at the cancers location. The other was armed with a protein that binds to the cancer cells and makes them commit suicide in an orderly process called apoptosis.

The researchers tested these engineered neural stem cells in mice that had been injected with human glioblastoma cells, which multiplied out of control to create a human cancer in a mouse body. Both of the weaponized stem cell groups were able to significantly shrink the tumors and keep the mice alive by about an extra 30 days (for scale, mice usually live an average of two years).

Were working as fast as we can.

But injecting the cells directly into the tumor doesnt really reflect how the therapy would be used in humans. Its more likely that a person with glioblastoma would get the bulk of the tumor surgically removed. Then, the idea is that these neural stem cells, generated from the patients own skin, will be inserted into the hole left in the brain. So, the researchers tried this out in mice, and the tumors that regrew after surgery were more than three times smaller in the mice treated with the neural stem cells.

Its a promising start, but it could take a few years still before its in the clinic, Hingtgen says. He and his colleagues started a company called Falcon Therapeutics to drive this new therapy forward. Were working as fast as we can, Hingtgen says. We probably cant help the patients today. Hopefully in a year or two, well be able to help those patients.

One of the things theyll have to figure out first is whether the neural stem cells can travel the much bigger distances in human brains, and whether theyll be able to eliminate every remaining cancer cell. The caveats on this are that, of course, its a mouse study, and whether or not that directly converts to humans is unclear, Marini says. Still, he adds, Theres a very high probability in this case.

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The next weapon against brain cancer may be human skin - The Verge

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