Brain cell replacement for Parkinson’s boosted by monkey study – The San Diego Union-Tribune

A brain cell replacement therapy reduced Parkinsons disease symptoms in monkeys, Japanese researchers report in a study released Wednesday. The positive result boosts prospects to test the therapy in people.

The goal is to implant neurons derived from stem cells into the brains of Parkinsons patients, a project pursued by scientists in San Diego, New York, Britain and Sweden as well as in Japan. If all goes well, the neurons will function as replacements for those destroyed in the disease.

In addition, human testing of a related brain cell therapy from Carlsbads International Stem Cell Corp. is already under way in Australia.

While treatments exist for the movement disorders caused by Parkinsons, none of them actually halt progression. Replacing the brain cells destroyed in Parkinsons holds the promise of actually reversing the disease.

Moreover, success with Parkinsons could pave the way to treating many other neurodegenerative diseases, such as ALS (Lou Gehrigs disease) and perhaps Alzheimers, along with brain and spinal cord injuries. These afflictions cost hundreds of billions annually, and most importantly, produce immense suffering in patients and caregivers.

Years of extensive research are required before any such therapy can be tried in people. Testing in monkeys or other primates is often regarded as the last step before human treatment can be contemplated.

The study was published in the journal Nature. Its senior author was Jun Takahashi, a prominent stem cell researcher at Kyoto University in Kyoto, Japan. Go online to j.mp/parkips for the study.

There is precedent to suggest the therapy might work. Beginning decades ago, brain cells taken from human fetuses have been implanted into the brains of Parkinsons patients, with mixed results. Some patients experienced improved movement control. But others gained nothing, or experienced uncontrolled movements.

Scientists in the field say using stem cells should provide improved results. Stem cells can be made in greater quantity than the limited number of fetal brain cells available. In addition, the stem cells and neurons made from them can be analyzed for quality before implantation.

The study was praised by regenerative medicine researcher Tilo Kunath at the University of Edinburgh, in comments provided by the UK Science Media Centre.

This is extremely promising research demonstrating that a safe and highly effective cell therapy for Parkinsons can be produced in the lab, Kunath said.

Such a therapy has the potential to reverse the symptoms of Parkinsons in patients by restoring their dopamine-producing neurons. The next stage will be to test these therapies in a first-in-human clinical trial.

In the study, researchers produced neurons that secrete dopamine, a neurotransmitter deficient in Parkinsons disease. These neurons were made from human stem cells derived from both healthy people and those with Parkinsons.

The researchers then implanted the human neurons into 10 monkeys whose own dopamine-making neurons had been destroyed. The monkeys were given immunosuppressive drugs to prevent rejection of the human cells.

The human neurons integrated into the brains of the monkeys and functioned as dopamine-making neurons. The monkeys improved in movement ability, save for one monkey that became ill and was euthanized. Both cells from healthy and Parkinsons patients were effective.

A companion study in Nature Communications demonstrated a method of immune-matching the cells to reduce the immune response. Takahashi was also senior author of that study. Go online to j.mp/ipsimmune for the study.

Both studies used artificial embryonic stem cells, called induced pluripotent stem cells (IPS). These act-alike cells are not derived from embryos, but are genetically reprogrammed from adult cells, usually skin cells.

The IPS cells appear to act virtually identically to embryonic stem cells, but dont raise the ethical objections many have to using embryonic stem cells. These cells were invented in 2006 by a team led by Shinya Yamanaka, a co-author of the Nature Communications study.

Moreover, the cells can be made from the patients themselves, which is not expected to cause an immune reaction. This is the approach taken by the San Diego team, including scientists at The Scripps Research Institute.

Carlsbads International Stem Cell Corp. uses a different approach. It starts with unfertilized, or parthenogenetic, human egg cells. These are grown into immature neurons that are implanted. The cells are expected to grow not only into dopamine-making neurons, but other kind of brain cells that preserve the remaining neurons.

The Australian clinical trial has gathered evidence of safety, and continued testing is under way determine efficacy.

The Nature study dovetails with research by the San Diego group, Summit for Stem Cell, (www.summitforstemcell.org), including scientists at The Scripps Research Institute and doctors at Scripps Health.

The group proposes to treat Parkinsons patients with neurons grown from their own IPS cells. The scientists have received funding from the California Institute for Regenerative Medicine, the states stem cell agency.

The studies support the personalized approach that we are taking for a neuron replacement therapy for Parkinson's disease patients, said Jeanne Loring and Andres Bratt-Leal, stem cell scientists at The Scripps Research Institute.

Two points from the studies should be highlighted, Loring and Bratt-Leal said by email.

Parkinson's disease is a late-onset disorder, they said. That means that there was nothing wrong with the neurons that people with Parkinson's were born with. Few PD patients have a family history of the disease, which suggests that genetic mutations did not cause their disease.

So for the great majority of patients, transplantation of their own neurons is a promising approach to relieving symptoms, without having to take expensive and risky immunosuppressive drugs, they said.

The Summit for Stem Cell scientists are members of an international partnership of laboratories developing neuron replacement therapies for Parkinsons, called GForce PD.

Takahashi belongs to the partnership, as do scientists in the UK, Sweden and New York. These use both embryonic and IPS stem cells. The Summit for Stem Cell effort is the only one using patient-matched IPS cells, Loring and Bratt-Leal said.

Brain cells reprogrammed to make dopamine, with goal of Parkinsons therapy

Parkinson's stem cell therapy shows signs of safety

Parkinson's therapy funded by California's stem cell agency

Dopamine-making neurons can be chemically controlled in animal model of Parkinson's

Stem cell clinical trial for Parkinson's begins

Summit for Stem Cell

bradley.fikes@sduniontribune.com

(619) 293-1020

Link:
Brain cell replacement for Parkinson's boosted by monkey study - The San Diego Union-Tribune

Collaboration Key to 3D Bioprinting Stem Cell Research Success at BioFab3D@ACMD in Australia – 3DPrint.com

Medical researchers and scientists have created all kinds of medical marvels, from brain tissue and cartilage to a heart and a pancreas, by 3D printing stem cells. In Australia, Swinburne University of Technology PhD candidateLilith Caballero Aguilar is currently collaborating on a project with surgeons and researchers at BioFab3D@ACMD, the countrys first bioengineering facility based in a hospital, about how stem cells are fed once theyre inside the body. She is working to develop methods to control the rate of release for growth factors, which stem cells need for development once theyve been implanted, and the research could help doctors use biological 3D printing techniques to regenerate damaged or missing tissue.

Caballero Aguilar says that working alongside surgeons and other university researchers at the facility has had a major impact on her work.

We complement each other. If I have doubt, we can discuss it and reshape the project as we go, which helps to reach a better outcome.At the end of the day, everyone is doing a bit of work in a big project. It feels very rewarding,Caballero Aguilar said.

The facility was established through a partnership between Swinburne, St Vincents Hospital Melbourne, the ARC Centre of Excellence for Electromaterials Science, the University of Melbourne,RMIT University, and the University of Wollongong Australia. Biology experts, surgeons, researchers, and biomedical engineers work at the facility to pioneer innovations, like nerves, re-engineered limbs, and tissues.

Cellink Inkredible Bioprinters [Image: Swinburne]

Caballero Aguilars stem cell work is part of two of the facilitys major research projects, one which focuses on repairing damaged muscle fibers and another regarding damaged cartilage regeneration; both are using advanced technologies, like bioprinting, to implant materials into the body, including the handheld 3D Biopen that allows surgeons to draw biomaterials into a patient directly and has been successfully tested, using knee cartilage, on six sheep.

BioPen

She is working to manipulate polymer materials into release mechanisms for stem cell growth factors, which would form part of the 3D bioink drawn into the body. Controlling the delivery of growth factors is very important stem cells take at least six weeks to grow into tissue, so the growth factors need to be slowly released over the entire time period.Caballero Aguilar shakes an oil and water solution at an intense rate, which is called the emulsion method, to create microspheres, which are crosslinked to form a substance thats able to hold the growth factors.

Swinburne Professor of Biomedical Electromaterials Science Simon Moulton, who is Caballero Aguilars supervisor, said that the success of her stem cell research project was helped along by the opportunity to collaborate directly with orthopaedic surgeons and muscle specialists at St Vincents Hospital.

Swinburne PhD candidate Lilith Caballero Aguilar and Professor Simon Moulton in a lab at BioFab3D@ACMD. [Image: Swinburne]

Professor Moulton said, Without this space, Liliths project would be a much smaller project without the translation benefit.It still would be great research done at a very high level, she would have publications and be able to graduate, but working in this collaborative environment, she can achieve all of that, while also having her research go into a clinical outcome that actually has benefit to patients.

Continue reading here:
Collaboration Key to 3D Bioprinting Stem Cell Research Success at BioFab3D@ACMD in Australia - 3DPrint.com

FDA cracks down on stem-cell clinics selling unapproved treatments – 89.3 KPCC

The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb said in a statement Monday.

The FDA has taken action against clinics in California and Florida.

The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for "marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements."

The clinic is one of many around the country that claim to use stem cells derived from a person's own fat to treat a variety of conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says.

The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration.

The FDA also said it has taken "decisive action" to "prevent the use of a potentially dangerous and unproven treatment" offered by StemImmune Inc. of San Diego, Calif., and administered to patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif.

As part of that action, the U.S. Marshals Service seized five vials of live vaccinia virus vaccine that is supposed to be reserved for people at high risk for smallpox but was being used as part of a stem-cell treatment for cancer, according to the FDA. "The unproven and potentially dangerous treatment was being injected intravenously and directly into patients' tumors," according to an FDA statement.

Smallpox essentially has been eradicated from the planet, but samples are kept in reserve in the U.S. and Russia, and vaccines are kept on hand as a result.

But Elliot Lander, medical director of the California Stem Cell Treatment Centers, denounced the FDA's actions in an interview with Shots.

"I think it's egregious," Lander says. "I think they made a mistake. I'm really baffled by this."

While his clinics do charge some patients for treatments that use stem cells derived from fat, Lander says, none of the cancer patients were charged and the treatments were administered as part of a carefully designed research study.

"Nobody was charged a single penny," Lander says. "We're just trying to move the field forward."

In a written statement, U.S. Stem Cell also defended its activities.

"The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration," according to the statement.

"We have helped thousands of patients harness their own healing potential," the statement says. "It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

But stem-cell researchers praised the FDA's actions.

"This is spectacular," says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. "This is the right thing to do."

Daley praised the FDA's promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on "snake-oil salesmen" marketing unproven treatments.

Stem-cell research is "a major revolution in medicine. It's bound to ultimately deliver cures," Daley says. "But it's so early in the field," he adds. "Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven't been proven to work and may be unsafe."

Others agreed.

"I see this is a major, positive step by the FDA," says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics.

"I'm hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell "treatments" that may not be real treatments," Knoepfler says.

Read more here:
FDA cracks down on stem-cell clinics selling unapproved treatments - 89.3 KPCC

Health Highlights: Aug. 29, 2017 – Bloomington Pantagraph

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Another Outbreak of Salmonella Traced to Pet Turtles

Thirty-seven people across 13 states have contracted salmonella infection from contact with pet turtles, the U.S. Centers for Disease Control and Prevention announced Tuesday.

The agency has for years warned Americans that reptiles such as turtles can be a potent source of the potentially dangerous bacterium, which attacks the gastrointestinal system.

In fact, the CDC notes that "since 1975, the FDA has banned selling and distributing turtles with shells less than 4 inches long as pets because they are often linked to salmonella infections, especially in young children."

In the the latest outbreak, illnesses began to appear on March 1 and diagnoses continued until Aug. 3, the agency said. No deaths have yet been reported, but 16 people have required hospitalization. The CDC says the outbreak may not yet be over.

The agency's advice? "Do not buy small turtles as pets or give them as gifts. All turtles, regardless of size, can carry Salmonella bacteria even if they look healthy and clean."

Federal Prisons Must Now Make Free Tampons, Pads Available

New policy from the Federal Bureau of Prisons (FBP) now requires that all facilities make feminine hygiene products, such as tampons and pads, available for free to prisoners who need them.

In an email memo issued earlier in August, FBP spokesman Justin Long said that "wardens have the responsibility to ensure female hygiene products such as tampons or pads are made available for free in sufficient frequency and number. Prior to the (memo), the type of products provided was not consistent, and varied by institution."

Andrea James is a former lawyer and founder of the National Council for Incarcerated and Formerly Incarcerated Women and Girls. In 2010 and 2011, she served 18 months in a federal prison.

Speaking with CNN, James recalled tough choices made by prisoners involving feminine hygiene products, which the prisoners themselves had to pay for.

"We were paid 12 cents an hour [for in-prison work]," she said, and that wage could be spent on other things, such as phone calls. "That's the choice. Do I buy the tampons or do I call my children?"

According to CNN, the new policy arrives a month after Democratic Senators Cory Booker, Elizabeth Warren, Dick Durbin and Kamala Harris introduced the Dignity for Incarcerated Women Act into Congress. Among other issues, the Act requires that women in prisons have access to multiple sizes of free tampons, pads and liners. Long said the new announcement had nothing to do with the proposed law, however.

In a statement, Harris said she applauded the memorandum, adding, "too many women reside in prison and jail facilities that don't support basic hygiene or reproductive health, and that's just not right."

FDA: Serious Problems at Florida Stem Cell Clinic

A Florida stem cell clinic has been cited by the U.S. Food and Drug Administration for what the agency describes as serious problems that could pose health risks to patients.

The agency said Monday that it has cited US Stem Cell Clinic, of Sunrise, for marketing stem cell products without FDA approval and for "significant deviations from current good manufacturing practice requirements," including some that could affect the "sterility of their products, putting patients at risk."

"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," FDA Commissioner Dr. Scott Gottlieb said in a news release.

The FDA said it recently inspected US Stem Cell Clinic and found that it was processing fat tissue into stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious health problems. Those problems included Parkinson's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), chronic obstructive pulmonary disease (COPD) and heart disease, among others.

The FDA said it hasn't approved any biological products made by US Stem Cell Clinic for any use.

During an inspection, FDA investigators also found evidence of "significant deviations from current good manufacturing practices" in the production of at least 256 lots of stem cell products. Those deviations included "failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections."

US Stem Cell Clinic also tried to hamper the FDA's investigation during a recent inspection "by refusing to allow entry except by appointment and by denying FDA investigators access to employees," the agency said.

Interfering with an FDA inspection is a violation of federal law, the agency said.

The FDA said it wants to hear from US Stem Cell Clinic within 15 working days, detailing how the problems cited in the agency warning letter will be fixed. If the problems aren't corrected, the company faces such enforcement actions as seizure, injunction or prosecutions, the agency said.

Original post:
Health Highlights: Aug. 29, 2017 - Bloomington Pantagraph