Stem Cell Clinic

Local man fundraising for Stem Cell Transplant Therapy – Sequim Gazette

By Stem Cell Treatment

Spaghetti dinner fundraiser

Proceeds benefit stem cell transplant for Sean McKeown

When: 4-8 p.m. Saturday, March 4

Where: Sequim Boys & Girls Club, 400 West Fir St., Sequim

Admission: $10 for adults, $6 for children ages 10 and under

For more: Contact Karen McKeown at karenlmckeown@gmail.com or visit https://www.gofundme.com/seans-stem-cell-therapy

Sean McKeown has been living with multiple sclerosis for 17 years.

After trying every medication available to stop the progression of the disease, McKeown finally was approved for stem cell transplant therapy that could significantly help improve his condition.

It has been a 17-year journey for the McKeowns, as Sean and his wife Karen describe it. The two met in a Human Relations class at college in Bellingham and got married six months after Sean was diagnosed with multiple sclerosis.

They now have two young children, Madison, 13, and Dylan, 12, that attend Sequim Middle School.

Sean was born and raised in Port Angeles. The McKeowns have been living in Sequim for five years and work for the family owned business called All Weather Heating and Cooling, Inc. located off Kemp Street in Port Angeles.

Seans parents Tom and Ida McKeown opened the business in the 1980s and later sold it to Seans sister Jeanne Sparks and her business partner Dustin Halverson. Karen currently works as the office manager and Sean also worked at the business until 2009 when he could no longer work.

Sean was first diagnosed with multiple sclerosis in 2000 after experiencing double vision. He is no longer able to take the previous medication he was using for 10 years. Last September, he got a call from the University of Washington that notified him he tested positive for the JC Anti-virus for most people it would be similar to the common cold but when Sean contracts the virus it means half of the multiple sclerosis drugs can cause a second disease called PML or brain cancer.

It was a huge wake up call for us, said Karen.

Multiple sclerosis causes Seans legs to constantly shake and he must walk with the assistance of a cane every day. He also has a lack of energy and at one point was in a wheelchair for several months because he did not have the energy to walk short distances.

The McKeowns said they did a lot of research about stem cell transplant therapy for treating multiple sclerosis and Sean was approved for the procedure after he applied. His approval only lasts for 10 weeks but his insurance does not cover the procedure so the McKeowns must raise $16,000 to cover the cost.

The idea behind the treatment is to take Seans stem cells out of his fat areas, such as the stomach, put the cells through a machine that cleans it and creates new stem cells. Doctors will then inject the cells back into his body where they will attach to blood cells and start the healing process.

For multiple sclerosis, stem cell transplant therapy could help with Seans movement and Karen added that doctors want to put some stem cells in his brain.

Sean explained that the bodys nerve endings are almost like a wire, when talking about the process. He explained his T-cells are attacking the fatty tissue surrounding the nerve endings and when these cells get down to the wire or nerve endings the wires snap and short out, he said.

In theory, those stem cells will re-attach those wires, Karen explained.

StemGenex is the San Diego, Calif.-based facility where the McKeowns will travel to have the procedure done. Karen said the facility has been performing stem cell transplant therapy for nine years to treat other diseases such as Parkinsons. The treatment could be done within three days but if the McKeowns do not raise the money for the procedure within 10 weeks, they will have to reapply.

The McKeowns said they are hoping this procedure will allow Sean to have more energy.

For him, mainly it will be his energy level, Karen said. That would be a huge step in the right direction for him.

Karen explained there were days where Sean could barely walk out to the mailbox and back and would need to rest shortly after.

The McKeowns have been trying to raise money for the procedure through a GoFundMe account and a bank account through First Federal under Benefit for Sean McKeown.

The family also is hosting a fundraiser at the Boys &Girls club in Sequim this Saturday, March 4, where there will be a spaghetti dinner and raffle items. So far the McKeowns have raised an estimated $3,000 and the deadline to reach their goal amount is April 24.

For more information about Sean, you can visit https://www.gofundme.com/seans-stem-cell-therapy.

The spaghetti fundraiser will be held from 4-8 p.m. at the Sequim Boys &Girls Club, 400 West Fir St. in Sequim. Admission is $10 for adults and $6 for children ages 10 and under. Contact Karen McKeown at karenlmckeown@gmail.com.

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Local man fundraising for Stem Cell Transplant Therapy - Sequim Gazette

Johns Hopkins Medicine, Maryland Stem Cell Research Fund and BioCardia Announce First Patient Treated with … – Business Wire (press release)

By Stell Cell Research

SAN CARLOS, Calif. & BALTIMORE--(BUSINESS WIRE)--Johns Hopkins Medicine, the Maryland Stem Cell Research Fund (MSCRF) and BioCardia, Inc. (OTC:BCDA) today announced that the first patient has been treated in the pivotal Phase III CardiAMP clinical trial of a cell-based therapy for the treatment of ischemic heart failure that develops after a heart attack. The first patient was treated at Johns Hopkins Hospital by a team led by Peter Johnston, MD, a faculty member in the Department of Medicine and Division of Cardiology, and principal investigator of the trial at Johns Hopkins.

The investigational CardiAMP therapy is designed to deliver a high dose of a patients own bone marrow cells directly to the point of cardiac dysfunction, potentially stimulating the bodys natural healing mechanism after a heart attack.

The patient experience with CardiAMP therapy begins with a pre-procedural cell potency screening test. If a patient qualifies for therapy, they are scheduled for a bone marrow aspiration. A point of care cell processing platform is then utilized to concentrate the autologous bone marrow cells, which are subsequently delivered in a minimally-invasive procedure directly to the damaged regions in a patients heart.

This cell-based therapy offers great potential for heart failure patients, said Carl Pepine, MD, professor and former chief of cardiovascular medicine at the University of Florida, Gainesville and national co-principal investigator of the CardiAMP trial. We look forward to validating the impact of the therapy on patients quality of life and functional capacity in this important study.

In addition to Dr. Johnston, the CardiAMP research team at Johns Hopkins includes Gary Gerstenblith, MD, Jeffrey Brinker, MD, Ivan Borrello, MD, Judi Willhide, Katherine Laws, Audrey Dudek, Michele Fisher and John Texter, as well as the nurses and technicians of the Johns Hopkins Cardiovascular Interventional Laboratory.

Funding the clinical trial of this cell therapy, which could be the first cardiac cell therapy approved in the United States, is an important step towards treatments, said Dan Gincel, PhD., executive director of the MSCRF at TEDCO. Through our clinical program, we are advancing cures and improving healthcare in the State of Maryland.

The CardiAMP Heart Failure Trial is a phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at up to 40 centers nationwide, which includes an optional 10-patient roll-in cohort. The primary endpoint for the trial is a significant improvement in Six Minute Walk distance at 12 months post-treatment. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack. The national co-principal investigators are Dr. Pepine and Amish Raval, MD, of the University of Wisconsin.

For information about eligibility or enrollment in the trial, please visit http://www.clinicaltrials.gov or ask your cardiologist.

About BioCardia BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the companys biotherapeutic product candidates in clinical development. For more information, visit http://www.BioCardia.com.

About Johns Hopkins Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is one of the leading health care systems in the United States. Johns Hopkins Medicine unites physicians and scientists of the Johns Hopkins University School of Medicine with the organizations, health professionals and facilities of The Johns Hopkins Hospital and Health System. For more information, visit http://www.hopkinsmedicine.org.

About Maryland Stem Cell Research Fund The Maryland Stem Cell Research Act of 2006was established by the Governor and the Maryland General Assembly during the 2006 legislative session and created the Maryland Stem Cell Research Fund. This fund is continued through an appropriation in the Governor's annual budget. The purpose of the Fund is to promote state-funded stem cell research and cures through grants and loans to public and private entities in the State. For more information, visit http://www.MSCRF.org.

Forward Looking Statements This press release contains forward-looking statements as that term is defined under the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, among other things, references to the enrollment of our Phase 3 trial, commercialization and efficacy of our products and therapies, the product development timelines of our competitors. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans, competition in the industry in which BioCardia operates and overall market conditions, and whether the combined funds will support BioCardias operations and enable BioCardia to advance its pivotal Phase 3 CardiAMP cell therapy program. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

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Johns Hopkins Medicine, Maryland Stem Cell Research Fund and BioCardia Announce First Patient Treated with ... - Business Wire (press release)

Findings reveal effect of embryonic neural stem cell development on later nerve regeneration capacity – Medical Xpress

By Stell Cell Research

March 1, 2017 Neural progenitor cells (green) in the lateral ganglionic eminence (LGE), the region in the developing brain that produces the majority of adult neural stem cells. Credit: Sven Falk

Neurodegenerative diseases such as Alzheimer's or Parkinson's, but also strokes or other types of traumatic brain damage, result in the death of nerve cells in the brain. Since the mammalian brain is capable of replacing nerve cells only in certain restricted regions, such nerve-cell loss is in most cases permanent. Similarly, the capacity to form new nerve cells in the mature brain is limited to specific areas. The cells responsible for neurogenesis in the mature brain are called adult neural stem cells, but little is known about their developmental origins. Now an international research collaboration led by Magdalena Gtz, Professor of Physiological Genomics at LMU's Biomedical Center and Director of the Institute for Stem Cell Research at the Helmholtz Zentrum Munich, has demonstrated that the mode of division of stem cells has a profound influence on the numbers of adult neural stem cells formed during embryonic development.

The new findings appear in the journal Neuron.

Neural cells develop from progenitors called neural stem cells, which are produced in large numbers during embryonic development. However, in the mature mammalian brain, very few of these progenitors survive as so-called adult neural stem cells capable of generating new nerve cells. In order to determine what enables these cells to retain their stem-cell character into adulthood, Gtz and her colleagues took a closer look at neural stem cells in the developing mouse embryo called radial glia cells (RGCs). RGCs form long processes that span the apicobasal axis of the neuroepithelium and their nuclei come to lie close to the apical surface which faces a fluid-filled cavity known as the ventricle. When RGCs divide, some of the daughter cells again are RGCs, i.e. the RGC self-renews. These cells that retain the self-renewing capacity, a characteristic of stem cells, are the source of the adult neural stem cells found in a specific region of the developing brain called the lateral ganglionic eminence, which forms the lateral wall of the ventricle in the adult brain. The nerve cells derived from the adult neural stem cells subsequently migrate into the olfactory bulb, one of the regions in which new nerve cells are integrated in the mature brain.

"We have now shown that the orientation of the plane of division of embryonic progenitor cells has a major impact on the production of adult neural stem cells," Gtz says. The plane of cleavage during cell division determines which parts of the cytoplasm are inherited by the two daughter cells. Most of the RGCs in the lateral ganglionic eminence were found to divide along a plane that is approximately vertical (at an angle of 60-90) to the apical cell surface. However, when the researchers genetically randomized the orientation of the cleavage plane such that the frequency of oblique or horizontal divisions was increased the number of adult neural stem cells generated was significantly reduced. Hence the orientation of the cleavage plane of RGCs is a crucial factor that affects the number of adult stem cells. However, timing also plays a crucial role. Adult neural stem cells are produced only during a specific, temporally and regionally restricted phase in embryonic development. Genetic randomization of the cleavage plane progenitor cells in the post-natal mouse brain proved to have no effect on the number of adult stem cells.

The total number of adult neural stem cells produced is a crucial determinant of the brain's capacity for repair and regeneration, because each of these cells can generate only a limited number of new nerve cells. "With a better understanding of how the formation of adult neural stem cells is regulated, we could look for ways of ensuring that other embryonic neural stem cells maintain this capacity, and perhaps even persuade other cell types to do so. Our new results represent an important step toward this goal," says Sven Falk, first author of the new study. The researchers hope that their findings will open up new approaches to the therapy of neurodegenerative diseases.

Explore further: Specific roles of adult neural stem cells may be determined before birth

More information: Sven Falk et al. Time-Specific Effects of Spindle Positioning on Embryonic Progenitor Pool Composition and Adult Neural Stem Cell Seeding, Neuron (2017). DOI: 10.1016/j.neuron.2017.02.009

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Findings reveal effect of embryonic neural stem cell development on later nerve regeneration capacity - Medical Xpress

Stem cell treatment changed the life of one guest at Trump’s speech – CNN

By Stell Cell Research

She credits an experimental stem cell treatment with giving her new hope for her health and her future -- a newfound hope that also caught attention of Republican Rep. Pete Olson.

"She is the face of the 21st Century Cures Act because of what she's gone through in her life," he said Tuesday.

"It became pretty clear to me that ... I (have) got to tell her story," he said. "That's why she's here: She's awesome."

Immediately after the House vote, Hughes said, Olson called her at home to invite her to be his guest of honor.

"I still cannot believe I will be in the same room as our President and lawmakers," she said before attending Trump's speech.

It took Crowley's father, John, to launch the New Jersey biotechnology company Amicus Therapeutics to identify a drug treatment that would save her life, Trump said.

"If we slash the restraints, not just at the FDA but across our Government, then we will be blessed with far more miracles like Megan," he said. "In fact, our children will grow up in a Nation of miracles."

Hughes spent most of her adolescence hospitalized, as she became so sick that she could barely walk and suffered immense pain. Her body was evaluated, treated and studied at the National Institutes of Health in collaboration with her doctors from the University of Texas Health Science Center at Houston.

Yet relief came in 2014, when Hughes received a high-dose adult stem cell treatment that was not approved in the United States.

For the procedure, Hughes had her own healthy stem cells cultured at the FDA-registered biotechnology company Celltex Therapeutics in Houston. Then she traveled to Cancun, Mexico, to have the cells infused back into her body.

Each infusion involved about 200 million stem cells, and Hughes received some 22 infusions over almost two years. The cells could help normalize her immune system, which was overactive due to her autoimmune disease.

Before the stem cell therapy, Hughes said, she was taking 23 medications a day. Now, she is on eight medications at lower doses.

"If not for the help of high-dose autologous mesenchymal stem cell therapy, I would not be here today," Hughes said at the hearing.

"I was running out of time, but I was willing to put my life at risk to get on an airplane. My quality of life had become so dismal, even one small improvement from my own stem cells would have been enough for me," she said in her speech. "What happened in the days, weeks and years following my first infusion has changed my outlook. It's hard to believe, in my sick body, I had a wealth of healthy adult stem cells with the ability to so significantly improve my quality of life."

"My hope is that our new President will spend time looking at how to help all Americans have access to new therapies like the one I had," she said.

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Stem cell treatment changed the life of one guest at Trump's speech - CNN

Bones made to order at University of Rochester, thanks to 3-D printers – Rochester Democrat and Chronicle

By Stem Cell Medical Center

Scientists at URMC are researching how to use 3-D printing to create bone replacement. Jamie Germano

University of Rochester Medical Center Scientists Hani Awad, left, and Edward Schwarz explain how they are leading the way in using 3-D printing and stem cells to create bone replacements for patients.(Photo: Jamie Germano/@jgermano1/Staff Photographer)Buy Photo

Imagine getting a made-to-order bone implanted in your body that's composed of your own cells.

Scientists at the University of Rochester Medical Center have been developing a procedure to use3-D printing and stem cells fromthe patient to createbones made of regenerated tissue.

Thismulti-step procedure still has a ways to go before it is tested on humans and can become part of the services provided by URMC's Center for Musculoskeletal Research.Butit's the latest example of how 3-D printing, which isincreasingly finding its place in manufacturing, is leaving its mark in medicine.

It is changing the way we do a lot of things, saidHani Awad, who is associate director of the center and professor of biomedical engineering with aspecialty in tissue engineering.

Biomedical research, as it is being done in this initiative, is an important component of the medical center's identity.

"Part of our mission is that we want to do research that is impactful," said Stephen Dewhurst, vice dean for research at the medical center.

A 3-D replica of a spinal deformity in a child that gives surgeons a hands-on look at a problem before surgery. The replica is made with a 3-D printer at the University of Rochester Medical Center.(Photo: Jamie Germano/@jgermano1/Staff P)

UR is already using 3-D printing to create replicas of human organs to practice on before conducting difficult surgical procedures.

The Center for Musculoskeletal Research is trying to gobeyond this use of3-D printing.

Simulated surgery makes headway at UR Medical Center

Edward Schwarz, director of the center, andAwadare heading up an initiative that not only makes replicas of bones for doctors to better understand and show patients the problems they face, butis alsousing 3-D printing to create the framework for regenerating bone tissue.

Currently, a person with a badly damaged limb that cannot be healed by surgical means faces amputation, followed bythe fitting of an artificial limb.

Bones from cadavers arealso sometimes used as replacement limbs, but there is a high failure rate withcadaver limbs over time. That's because cadaver bonesare not living tissue and thus cannot repair themselves when the limb suffers minor fractures, as they often do.

Bone regeneration offers the prospect of a new alternative.

Thesurgically implanted replica serves as a framework to regenerate bone tissue.

"A big part of the problem is figuring out how to grow a big piece of bone,"said Awad.

With the technology developed, a3-D replicais created by taking a CT scan of the patient's bone. What's recorded by the scan is thenconverted by a computer into a digital modelthat programsthe 3-D printer.

If a leg is too badly damaged tomake a replica, a CTscan can be taken of the patient's other leg. And with the use of computer technology, any needed modification can be made. ACT scan of a left leg could be made to look like it isa right leg in the 3-D printout.

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During a recent demonstration, thestainless steel platform of the 3-D printer,which moves up and down, wasreplenished with a supply of powdered calcium phosphate a materialsimilar to bone.

The printer's inkjets wereprogrammed by computer to spray a binding solution of phosphoric acid in a patternthat formed a thighbone.

Over the course of an hour or so, the 3-D printer creating one thin layer on top of another builtthe artificial human boneabout 1 inch thick and 6inches long.

But that's not where this bone replacement procedure ends.

The next step and one not yet tried on humans is regeneration of tissue using stem cells wrapped around the replacementbone.

Schwarz and Awad have beentesting bone regeneration on mice, without any indicationof rejection and with signs of bone regeneration.

And they are beginning to test regeneration on mini-pigs.

The 3-D replica bones arecoated with sheets ofstem cells, whichregenerate bone tissue. Eventually, the 3-D part of the replacement bones made of calcium phosphate isexpected to be absorbed by new bone tissue.

Awad estimates that this tissue regeneration technology couldbe triedon humans in three to five years.

Research at the University of Rochester uses 3-D printing to create bone replacements. Jamie Germano

UR is among a handful of universitiesdoing research that combines 3-D technologyand tissue regeneration.

"The exact horizon is unclear, but we are certainlyrunning full-speed ahead," said Dr. Paul Rubery, chairman of the Department of Orthopaedics at the UR Medical Center.

3-D printing, Rubery noted, makes possible the reproduction of intricate shapes, including those in the human body.

"What is the science one might say what is the magic that will make a person's body take on a new part and make it a living part?" said Rubery about the possibility of bone regeneration using stem cells and 3-D technology.

The Medical Center is well positioned to figure this out.

"We havea long tradition of understanding the molecular processes that lead to healing and repair of the skeleton," said Rubery.

The Musculoskeletal Center, which is inRubery'sdepartment, last fiscal year received the second highest amount of funding for such centers fromthe National Institutes of Health roughly $10 million. About65 researchers and technicians are on staff.

The other half of the equation is the Medical Centers Upstate Stem Cell cGMP Facility, where stemcells are grown in accordance with strict Food and Drug Administration regulations.

Located in the Medical Center's Ernest J. Del Monte Neuromedicine Institute, the cGMP was established in 2012, with the help of a $3.5 million grant from the Empire State Stem Cell Board.

In bone regeneration, the stem cells are usually taken by syringe at the hip, where such cells are plentiful, and then grown in petri dishes atthecGMP Facility.

Schwarz, who is a professor of orthopaedics, said what's mostneeded before the procedure can beused on humans is work on how the stem cells are transferred from the cGMP facility to the 3-D replicas.

"Youbasically have to demonstrate that you can harvest the cells, grow the cells andre-implant the cells in a safe and effective manner," said Schwarz.

Currently, the alternative to an artificial leg is one from a cadaver, but that is done only in limited situations.

"If the bone is not alive, it eventually becomes structurally weakened," said Dewhurst.

Bone grafts are also done, buthere, too,the graftcomesfrom cadavers in thevast majority of cases, said Awad.

Regenerating bone tissue would provide a different dynamic creating live bone tissue that replenishes itself.

Rejection is not expected to be an issue because the stem cellswould come from the patient.

Unlike other cells, stem cells have the capability to divide indefinitely, so they can grow new bone tissue.

Awad and Schwarz are among the authors of studies in scientific journals that show the effectiveness of stem cells in healing damaged bones in mice.

In a laboratory at the Musculoskeletal Center is a tabletop full of replicas of human bones and bone structures made by the 3-D printer in the room.

The replica of the spine is that of a childwho suffered from a severe curvature.

Having such a model enabled a doctor to figure out what kind of steps could be taken to address the problem.

The 3-D skull on the table is a replica of a human skulland provides a way researchers can study howinjuries can be treated.

A hole was made in the cheekbone to resemble a bullet wound. Another replicawas missing part of a jaw.

Inboth cases, the goalis to have stem cells regenerate bone tissue.

The body can naturally healitself in the normal course of injuries, but can't do so when the bone is damaged beyond repair.

Implanting a 3-D bone coated withhuman stem cells would offer an alternative to existing choices.

"It is really going to be part of UR Medicine and its health care system," said Schwarz.

JGOODMAN@Gannett.com

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Bones made to order at University of Rochester, thanks to 3-D printers - Rochester Democrat and Chronicle

Harvard scientist worries we’re ‘reverting to a pre-Enlightenment form of thinking’ – SCNow

By Embryonic Stem Cells

George Q. Daley, the new head of Harvard Medical School, knows what it's like when presidential politics collides with science. Daley was a leading stem cell scientist back in 2001 when President George W. Bush suddenly barred federal funding for research on new embryonic stem cells - a gesture to Republican antiabortion backers that, many believe, put a chill on one of the most cutting-edge areas of biology.

The move turned many scientists, unexpectedly, into activists. The diplomatic Daley helped Harvard create an institute in 2004 to work around the federal funding restrictions; California bucked the Bush administration by devoting its own state funds to the research. President Barack Obama eventually reversed the executive order in 2009, allowing federal funds to be used; today, embryonic stem cell based therapies are being tested in clinical trials, and studying them has helped unleash a wave of new medical insights.

As of Jan. 1, Daley occupies one of the highest-profile jobs in American medicine, a de facto spokesman both for research and medical practice. And he arrives at a moment when the entire field is nervous about what the Trump administration has in store. The White House seems not only indifferent to research, but also actively hostile to some strains of science; the future of the Affordable Care Act is uncertain at best. Drug prices, immigration and the national research budget - all issues crucial to the medical field - are all up for debate. By nature a scientist, accustomed to gathering evidence before opining about solutions, Daley says he thinks his experiences working in a field that was marginalized by politicians may provide some useful lessons for navigating what he called a "cacophony of confusion and alternative facts."

Daley spoke to The Washington Post about his hopes and concerns as he takes the helm at Harvard Medical School - around the same time as President Trump. This interview has been edited for clarity and length.

Q. Right now, there's uneasiness in the scientific and medical communities over how evidence and research will be treated, ranging from vaccines to climate change. Having lived through a time when your work was directly politicized and targeted, what are your thoughts about how to approach a situation like that?

A. I think that the lessons that I learned in the early challenges and policy debates around embryonic stem cells have a lot to teach us for how to advocate forcefully in today's world. We have to, as scientists, stick to our message, which is that science and evidence is the way to make informed decisions - whether those decisions are about advancing human health and wellness, or about advancing the environment and maintaining not only healthy air quality, but reducing risks to catastrophic climate change. These are all fundamentally, at some level, challenges and risks to human health.

If I had one worry, as we see the cacophony of confusion and alternative facts, it's that we're reverting to a pre-Enlightenment form of thinking, which will take us back to the days of blood-letting and faith-healing. And this is wrong. This is not the way to advance health and wellness for the greatest number, not a way to face our challenges. We are facing some of the greatest global challenges today - not just with global warming, but with threats to emerging pathogens, whether it's Ebola or Zika. And if we start to question the nature and value of things like vaccines in human health, how are we going to be able to confront the challenges of new pathogens?

Q. Do you think that this is something that's already happening, or is it a future worry?

A. The storm clouds are on the horizon. If I just speak to one issue that has a very direct effect on our community: Our biomedical research enterprise, as well as our clinicians draw on the best and brightest, from not only the United States, but around the globe. We are a magnet, we're seen as the beacon of the best, cutting-edge research and the most effective and impactful clinical training and health care delivery. I've met with students from Iran and Syria who are here studying and about to graduate. And they're worried that their parents are not going to be able to come see them receive their PhD or their MD. We're worried about the pipeline - not only of trainees who keep us at the cutting edge, but patients. Our health care centers are magnets for patients from all over the world, and in many cases from the Middle East, and it stands in the way of our mission.

Q. The immigration policy of the Trump administration is evolving as we speak, but it sounds like you're worried about the message that recent actions send.

A. Our concern is that there is a megaphone that screams across the globe. Over the couple-hundred-year history of our country, it has been emblazoned on the Statue of Liberty: Give us your tired, your poor. We are a welcome beacon to immigrants from all across the globe; that's been the message that has built our country. And now the recent message that has been sent is giving pause to those folks in other parts of the world, making them think twice about whether this is a welcoming community for them. I've already heard that some of our applicants to post-doctoral positions or training programs in our graduate schools are starting to be diverted to programs in Europe that are saying, "Hey, what can we do to take advantage of the talent pool that might not be going to the United States." That is chilling to me.

Q. What are your thoughts on the plans to repeal the Affordable Care Act and what should come next?

A. We now have, in Massachusetts, 96 percent of people covered, and I do think that's created a sense in our medical students and our residents and our trainees, and even up to our faculty, that universal access [to health care] is a human right. I remember in my times in the hospital, there was something absolutely wonderful about the fact the homeless person coming off the street with a heart attack got the same intense, compassionate care as the Berkeley professor who had a heart event at Logan Airport - and that's an actual case that took place when I was in training. There's probably no other experience in my time as at trainee at the Harvard hospitals that made me feel more proud about the mission of Harvard medicine. I think that's an aspiration - there was an attempt by the Obama administration to capture that as an aspiration, as the noblest calling of medicine, and I think that anything that is put in it place has to attempt to meet those same aspirations.

Q. Stem cell science has come under political attack in the past, and Vice President Pence has said he opposes embryonic stem cell research. Are you worried about the future of your field?

A. I always felt very strongly and passionately, as an advocate for stem cell research of all kinds. To be able to use the new technology and biology of regenerative medicine to serve the relief of suffering and the treatment of disease, I just think is a very noble calling. I've always argued that we need to exploit every possible advantage in the fight against disease. I would continue to advocate for research on all sorts of stem cells. And if there is an attempt to restrict the research in the future, I will be out there again, speaking from the scientific and medical perspective to justify this work.

Carolyn Johnson is a reporter covering the business of health. She previously wrote about science at The Boston Globe

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Harvard scientist worries we're 'reverting to a pre-Enlightenment form of thinking' - SCNow

Stem cells fiercely abide by innate developmental timing, study shows – Science Daily

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Stem cells fiercely abide by innate developmental timing, study shows
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Developmental clocks are of high importance to regenerative medicine, since many cell types take long periods to grow to maturity, limiting their usefulness to human therapies. The regenerative biology team at the Morgridge Institute for Research, led ...

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Stem cells fiercely abide by innate developmental timing, study shows - Science Daily

Cellular Biomedicine Group Awarded $2.29 Million Grant from the California Institute for Regenerative Medicine (CIRM … – EconoTimes

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Cellular Biomedicine Group Awarded $2.29 Million Grant from the California Institute for Regenerative Medicine (CIRM) to Fund AlloJoin Allogeneic Stem Cell Therapy for Knee Osteoarthritis (KOA) in the U.S.

SHANGHAI, China and CUPERTINO, Calif., Feb. 27, 2017 -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG)(CBMG or the Company), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, announced today that the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, has awarded the Company $2.29 million to support pre-clinical studies of AlloJoinTM, CBMGs Off-the-Shelf Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States.

While CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM in Knee Osteoarthritis (KOA), this latest announcement represents CBMGs initial entrance into the United States for its off-the-shelf allogeneic stem cell candidate AlloJoinTM.

The $2.29 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. After the award, CIRM will be a more active partner with its recipients to further increase the likelihood of clinical success and help advance a pre-clinical applicants research along a funding pipeline towards clinical trials. CBMGs KOA pre-clinical program is considered late-stage, and therefore it meets CIRM 2.0s intent to accelerate support for clinical stage development for identified candidates of stem cell treatments that demonstrate scientific excellence.

"We are deeply appreciative to CIRM for their support and validation of the therapeutic potential of our KOA therapy, said Tony (Bizuo) Liu, Chief Executive Officer of CBMG. We thank Dr. C. Thomas Vangsness, Jr., in the Department of Orthopaedic Surgery at the Keck School of Medicine of the University of Southern California and Dr. Qing Liu-Michael at the Broad Center for Regenerative Medicine and Stem Cell Research at USC, who helped significantly with the grant application process. The CIRM grant is the first step in bringing our allogeneic human adipose-derived mesenchymal stem cell treatment for knee osteoarthritis (AlloJoinTM) to the U.S. market.

Our AlloJoinTM program has previously undergone extensive manufacturing development and pre-clinical studies and is undergoing a Phase I clinical trial in China. In order to demonstrate comparability with cell banks previously produced in China for our U.S. IND filing, we are addressing the pre-clinical answers required for the FDA. With the funds provided by CIRM, we will replicate and validate the manufacturing process and control system at the cGMP facility located at Childrens Hospital Los Angeles to support the filing of an IND with the FDA. The outcome of this grant will enable us to have qualified final cell products ready to use in a Phase I clinical trial with Dr. Vangsness as the Principal Investigator and the Keck School of Medicine of USC as a trial site. Dr. Vangsness is familiar with both stem cell biology and KOA, and has led the only randomized double-blind human clinical study to investigate expanded allogeneic mesenchymal stem cells to date. Our endeavor in the U.S. market will further strengthen our commercialization pipeline.

CBMG recently announced promising interim 3-month safety data from its Phase I clinical trial in China for AlloJoinTM, its off-the-shelf allogeneic stem cell therapy for KOA. The trial is on schedule to be completed by the third quarter of 2017.

About CIRM

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and to act with a sense of urgency commensurate with that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies.

With $3 billion in funding and over 280 active stem cell programs in our portfolio, CIRM is the world's largest institution dedicated to helping people by bringing the future of medicine closer to reality.

For more information, please visit http://www.cirm.ca.gov.

About Knee Osteoarthritis

According to the Foundation for the National Institutes of Health, there are 27 million Americans with Osteoarthritis (OA), and symptomatic Knee Osteoarthritis (KOA) occurs in 13% of persons aged 60 and older. The International Journal of Rheumatic Diseases, 2011 reports that approximately 57 million people in China suffer from KOA. Currently no treatment exists that can effectively preserve knee joint cartilage or slow the progression of KOA. Current common drug-based methods of management, including anti-inflammatory medications (NSAIDs), only relieve symptoms and carry the risk of side effects. Patients with KOA suffer from compromised mobility, leading to sedentary lifestyles; doubling the risk of cardiovascular diseases, diabetes, and obesity; and increasing the risk of all causes of mortality, colon cancer, high blood pressure, osteoporosis, lipid disorders, depression and anxiety. According to the Epidemiology of Rheumatic Disease (Silman AJ, Hochberg MC. Oxford Univ. Press, 1993:257), 53% of patients with KOA will eventually become disabled.

About Cellular Biomedicine Group (CBMG)

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Our immuno-oncology and stem cell projects are the result of research and development by CBMGs scientists and clinicians from both China and the United States. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. To learn more about CBMG, please visit http://www.cellbiomedgroup.com.

Forward-looking Statements

This press release contains forward-looking statementsincluding descriptions of plans, strategies, trends, specific activities, investments and other non-historical factsas defined by the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently uncertain, and actual results could differ materially from those anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy (including the devaluation of the RMB by China in August 2015), and other risks detailed in CBMGs reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," "continue" or similar terms or their negations. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

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