Archive for the ‘Stem Cell Medicine’ Category

Cambridge Enterprise and Qkine to drive stem cell and regenerative medicine research – Business Weekly

Stem Cell Medicine | Posted by admin
Sep 02 2017

Cambridge Enterprise, the commercialisation arm of the University of Cambridge, and specialist growth factor manufacturer Qkine Ltd have signed a key licensing deal for Activin A production technology.

Qkine is a recent spin-out from the university. The newly-licensed methodology, which was developed by one of the companys founders Dr Marko Hyvnen, will be used to manufacture proteins utilised for control of stem cell growth and differentiation.

Growth factors are proteins that transmit signals from one cell to another in higher organisms, orchestrating organisation of the developing embryo and regulating biological functions and repair processes in adults. Activin A, and others from its family of proteins, are essential ingredients used by stem cell scientists to mimic the environment in the human body. They allow carefully synchronised messages to be sent to stem cells, effectively telling them to turn into the desired cell type.

With exponential growth in the study of stem cells for disease modelling, drug screening, precision medicine and development of new therapeutics the need for high quality reagents for fine control of stem cell cultures is ever increasing.

Growing demand for Activin A and related growth factors and an opportunity to use protein engineering techniques to optimise these growth factors motivated Hyvnen and co-founder Dr Catherine Onley, a translational scientist, to start Qkine. Its mission is to produce high quality bioactive proteins for stem cell researchers and the regenerative medicine industry.

Hyvnen said: I have been providing growth factors to the Cambridge stem cell community for almost a decade.

Demand is growing from labs outside Cambridge and forming Qkine will allow us to focus on producing the highest quality cytokines for these scientists and establish a unique UK-based supplier of one of the enabling technologies for regenerative medicine, one of the priority areas for British manufacturing recently identified by the Government.

Qkine co-founders Dr Marko Hyvnen (picture courtesy - Chris Green) and Dr Catherine Onley (picture courtesy Suzi Ovens)

Qkine was awarded a Cambridge Enterprise Pathfinder investment in December 2016 to facilitate the founding of the company. Qkine started operation as an embedded company at the Department of Biochemistry in April 2017.

Dr Iain Thomas, head of Life Sciences at Cambridge Enterprise, said: Qkine is a great example of how opportunities are incubated in the University until the commercial time is right.

We are delighted that Qkine is taking this technology into the stem cell and regenerative medicine markets both of which are important and rapidly growing.

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Cambridge Enterprise and Qkine to drive stem cell and regenerative medicine research - Business Weekly

Six Japanese arrested over medical treatments using blood taken from umbilical cords, which are popular with Chinese … – South China Morning Post

Stem Cell Medicine | Posted by admin
Sep 01 2017

Six people have been arrested in Japan over the illegal sale and use of blood from umbilical cords and placenta in regenerative medical treatments, with Chinese nationals reportedly the biggest foreign clients of clinics carrying out the procedures.

Police have referred Tsuneo Shinozaki, the head of a company that brokered the illegal sale of cord blood, to prosecutors, along with the head of a Tokyo regenerative medicine clinic and four others. The doctor has also been charged with breaking the law on regenerative medicine.

Blood taken from umbilical cords and placenta is high in blood-forming stem cells, which are used in treatments for leukaemia and other critical diseases. There are also hopes that research into regenerative medicine will find cures to cardiac and other complaints, and may even mitigate the effects of Parkinsons disease by implanting nerve cells into the brain.

Chinese people misunderstand stem cell treatments and they just see it as some sort of magic solution

Manager of a Tokyo clinic

There are, however, elevated risks of infection and graft rejection, meaning any procedures using cord blood require extensive testing to ensure compatibility and explicit authorisation from Japans health ministry.

Claims the blood is also an effective beauty treatment have not been proven but that has not put off more than 1,000 patients undergoing such procedures at facilities across Japan in recent years. It has also been claimed it is effective in treating cancer, although that suggestion also remains unproven to date.

The manager of a clinic in Kyoto told local media Chinese people who had learnt of regenerative therapies had travelled to Japan on organised medical tourism trips.

Chinese people misunderstand stem cell treatments and they just see it as some sort of magic solution to any health problems that they have, the manager of a Tokyo-based clinic told the South China Morning Post.

They come to Japan because this sort of treatment is not available in China and because Japan is seen as being advanced in this area and having good medical facilities, said the official, who declined to be named and insisted his facility did not conduct procedures using umbilical cord blood.

He added that, under Japanese law, clinics are limited in the services they are able to advertise on their websites, but some clinics take out advertisements in China through other companies, enabling them to evade scrutiny.

It is not illegal for Chinese people to travel abroad for medical procedures, including regenerative therapies.

According to investigators, illegal injections of umbilical cord blood were conducted at clinics and private hospitals in at least 20 prefectures across Japan, with about 30 per cent of the clients from overseas.

Facilities charged between 3 million yen (HK$212,500) and 4 million yen for each injection.

By law, umbilical cord blood is donated free of charge to publicly operated blood banks by women after they have given birth. The blood is kept in storage. Such banks have to be licensed and are closely regulated to ensure safety.

The blood used in the recent unmonitored treatments was obtained from a blood bank that went bankrupt. Brokers paid to obtain the blood and sold it on to clinics.

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Six Japanese arrested over medical treatments using blood taken from umbilical cords, which are popular with Chinese ... - South China Morning Post

FDA announces actions regarding stem cell treatments – Lexology (registration)

Stem Cell Medicine | Posted by admin
Sep 01 2017

Together with new guidance regarding the potential regulatory pathways for gene therapies, the FDA announced on Monday, August 28, 2017, that it will be taking action against companies providing unapproved stem cell treatments. This new guidance, combined with the threat of enforcement actions, provides the regenerative medicine industry and its partners with certain direction regarding the differences between pioneering stem cell therapies for which regulatory pathways are being crafted and unapproved treatments, which are likely to trigger scrutiny by the FDA.

Overview of enforcement actions

On August 24, the FDA issued a warning letter to a Florida clinic that recovered a patient's own adipose tissues, processed those tissues into stromal vascular fraction (SVF) i.e., adult stem cells derived from the patient's own fat and then administered the SVF to the patient for treatment of any one of several conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS) and chronic obstructive pulmonary disease (COPD).

The FDA rejected the clinic's arguments that

Instead, the FDA took the position that the post-recovery processing of the adipose tissues takes the procedure outside of both the definition of an HCT/P and the same-surgical-procedure exception. The agency further noted that use of SVF for conditions such as Parkinson's disease, ALS and COPD do not meet the homologous use requirement of 21 CFR 1271.10. The agency also announced an action against a separate stem cell therapy clinic in California.

In light of these developments, practitioners and clinics who are

Guidance for regenerative medicine companies

While announcing these regulatory and enforcement actions, the FDA also sought to reassure the regenerative medicine industry of the agency's dedication to promoting this field of science. FDA Commissioner Scott Gottlieb wrote that the agency plans to "advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field." Manifesting the agency's willingness to work with industry, Dr. Gottlieb noted that while "[m]any of the individualized treatments fall clearly outside the FDA's pre-market requirements[f]or those that currently fall across the line and are subject to the FDA's existing pre-market review, we want to make sure the process for gaining FDA approval is efficient. We want to facilitate innovation." Thus, while signaling its intent to take action against entities it believes are "targeting vulnerable patients," the FDA indicated that it "will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path towards approval."

The FDA also reaffirmed its commitment to fully implementing the regenerative medicine advanced therapy (RMAT) designation process. The designation is given to cell therapies, therapeutic tissue engineering products, human cell and tissue products, or any combination product using such therapies or products intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. See Section 3033 of the 21st Century Cures Act.

These are important developments for stakeholders across the regenerative medicine industry, including:

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FDA announces actions regarding stem cell treatments - Lexology (registration)

In utero stem cell transplants may replace riskier childhood transplants for multiple conditions – Medical Xpress

Stem Cell Medicine | Posted by admin
Aug 31 2017

August 31, 2017 by Suzanne Leigh Tippi MacKenzie, MD, a pediatric and fetal surgeon at UCSF Benioff Childrens Hospital San Francisco, is the principal investigator for a clinical trial that will use in utero stem cell transplants to treat fetuses with an inherited disorder that restricts the bloods ability to carry oxygen to vital organs. Credit: Cindy Chew

UCSF Benioff Children's Hospitals in San Francisco and Oakland will pioneer stem cell transplants for a uniquely challenging patient population: second-trimester fetuses stricken with a potentially fatal disease.

The two hospitals are enrolling 10 pregnant women in the first phase of a clinical trial to treat fetuses with an inherited disorder that restricts the blood's ability to carry oxygen to vital organs. The trial, the first of its kind in the world, is funded by a $12.1 million grant from the California Institute for Regenerative Medicine.

Alpha thalassemia (ATM) affects 5 percent of the world's population, but is significantly more prevalent in China, Southeast Asia, India and the Middle East parts of the globe where many residents of the San Francisco Bay Area claim their origins. In its most extreme form, alpha thalassemia major (ATM), the condition leads to progressive anemia and heart failure before birth. Standard treatment in the United States includes lifelong blood transfusions.

Stem cell transplants from a matched donor in childhood have proven to be curative in some cases, but patients face risks, including graft-versus-host disease and serious side effects from immune-suppression drugs.

The trial is based on the premise that risks could be minimized by harnessing the "tolerance" between the pregnant woman and fetus before birth, said principal investigator Tippi MacKenzie, MD, a pediatric and fetal surgeon at UCSF Benioff Children's Hospital San Francisco.

Hope That Procedure Could Be Adopted Worldwide

"In performing the procedure in utero when the fetus's immune system is underdeveloped, we can avoid the aggressive treatments required for postnatal transplants for children with alpha thalassemia," MacKenzie said. "Eventually, the procedure may become a treatment option in parts of the world where ATM is most common. Due to lack of treatment possibilities in many countries, most pregnancies are either terminated on diagnosis or result in fetal demise," she said.

The trial follows a decades-long odyssey marked by triumphs and tribulations for researchers in the field. Fetal transplants using stem cells from other fetuses to treat blood disorders were carried out in the 1980s, but were only marginally successful due to engraftment failure. Researchers around the world searched for answers by turning to animal studies.

'Eureka Moment' Spurred Sea Change

"The fetus, unlike a fully developed human, can accept foreign cells, because its immune system is not yet primed to fight bacteria and viruses," said MacKenzie. "This undeveloped immune system benefits the fetus throughout the pregnancy, because it prevents it from launching an immune response to its mother's cells that are naturally circulating in its bloodstream."

Further research led to Mackenzie's "eureka moment," when it was discovered that the mother's immune system is actually responsible for rejecting other cells that are transplanted into the fetus. If the mother's cells are transplanted, they can engraft without being rejected. "This led to a sea change in our strategy to use maternal cells for the transplants," she said.

In the trial, bone marrow will be collected from women who are between 18 and 25 weeks pregnant, with a fetal diagnosis of ATM. The bone marrow cells will be processed and hematopoietic cells immature stem cells that can evolve into all types of blood cells will be singled out from the mix. They will then be injected through the woman's abdomen, into the umbilical vein of the fetus, where they can circulate through the bloodstream, developing into healthy mature blood cells.

The procedure is not without risks to the fetus and the pregnant woman. To minimize risks, the researchers restricted the trial to ATM, since the fetus is already undergoing blood transfusions. "An additional procedure for the transplantation is not necessary, since the maternal stem cells are infused at the same time as an in utero blood transfusion," said Elliott Vichinsky, MD, director of hematology/oncology at UCSF Benioff Children's Hospital Oakland, who will head the hematologic management of the fetus and newborn. "This should reduce additional risks to the fetus." Since the underlying disease causes complications, the woman will be monitored throughout her pregnancy and the fetus will continue to receive blood transfusions until birth.

UCSF is a pioneer in thalassemia research and the birthplace of fetal surgery. UCSF Benioff Children's Hospital Oakland is home to the Northern California Comprehensive Thalassemia Center, which was established in 1991 and is now the largest such program nationwide, with a focus on caring for patients and leading research into new treatments.

"We are excited about launching this trial, which combines the expertise of UCSF Benioff Children's Hospitals in San Francisco and Oakland. This study offers families with a usually fatal ATM pregnancy the chance of survival and cure," said Vichinsky, who founded the Northern California Comprehensive Thalassemia Center.

Treatment May Be Tested for Sickle Cell Anemia

Patient recruitment will continue for five years, during which pregnant women and their babies will be followed after birth for 30 days and one year respectively. If successful, the procedure will be carried out for fetuses with beta thalassemia, a more common and less serious variant of the disorder, as well as sickle cell anemia, in collaboration with Children's Hospital of Philadelphia. Other conditions requiring stem cell transplants after birth may be considered, said MacKenzie.

The incidence of ATM is unknown because most fetuses with the disorder die before delivery. The condition occurs when both parents are carriers for thalassemia. In places where women have access to prenatal care, ATM is usually suspected on ultrasound and confirmed by DNA analysis in the second trimester.

Explore further: Immune system drives pregnancy complications after fetal surgery in mice

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In utero stem cell transplants may replace riskier childhood transplants for multiple conditions - Medical Xpress

Human Stem Cells Fight Parkinson’s Disease in Monkeys – Scientific American

Stem Cell Medicine | Posted by admin
Aug 31 2017

LONDON (Reuters)Scientists have successfully used reprogrammed stem cells to restore functioning brain cells in monkeys, raising hopes the technique could be used in future to help patients with Parkinsons disease.

Since Parkinsons is caused by a lack of dopamine made by brain cells, researchers have long hoped to use stem cells to restore normal production of the neurotransmitter chemical.

Now, for the first time, Japanese researchers have shown that human induced pluripotent stem cells (iPS) can be administered safely and effectively to treat primates with symptoms of the debilitating disease.

So-called iPS cells are made by removing mature cells from an individualoften from the skinand reprogramming them to behave like embryonic stem cells. They can then be coaxed into dopamine-producing brain cells.

The scientists from Kyoto University, a world-leader in iPS technology, said their experiment indicated that this approach could potentially be used for the clinical treatment of human patients with Parkinsons.

In addition to boosting dopamine production, the tests showed improved movement in affected monkeys and no tumors in their brains for at least two years.

The human iPS cells used in the experiment worked whether they came from healthy individuals or Parkinsons disease patients, the Japanese team reported in the journal Nature on Wednesday.

This is extremely promising research demonstrating that a safe and highly effective cell therapy for Parkinsons can be produced in the lab, said Tilo Kunath of the MRC Centre for Regenerative Medicine, University of Edinburgh, who was not involved in the research.

The next step will be to test the treatment in a first-in-human clinical trial, which Jun Takahashi of Kyoto University told Reuters he hoped to start by the end of 2018.

Any widespread use of the new therapy is still many years away, but the research has significantly reduced previous uncertainties about iPS-derived cell grafts.

The fact that this research uses iPS cells rather human embryonic stem cells means the treatment would be acceptable in countries such as Ireland and much of Latin America, where embryonic cells are banned.

Excitement about the promise of stem cells has led to hundreds of medical centers springing up around the world claiming to be able to repair damaged tissue in conditions such as multiple sclerosis and Parkinsons.

While some treatments for cancer and skin grafts have been approved by regulators, many other potential therapies are only in early-stage development, prompting a warning last month by health experts about the dangers of stem-cell tourism.

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Human Stem Cells Fight Parkinson's Disease in Monkeys - Scientific American

Puppies benefit from stem cell treatment for children with spina bifida – University of California

Stem Cell Medicine | Posted by admin
Aug 31 2017

A pair of English bulldog puppies are the first patients to be successfully treated with a unique therapy a combination of surgery and stem cells developed at the University of California, Davis, to help preserve lower-limb function in children with spina bifida.

Because dogs with the birth defect frequently have little control of their hindquarters, they also have little hope for a future. They are typically euthanized as puppies.

At their postsurgery re-check at 4 months old, however, the siblings, named Darla and Spanky, showed off their abilities to walk, run and play to their doctor,veterinary neurosurgeon Beverly Sturges.

The initial results of the surgery are promising, as far as hind limb control, said Sturges. Both dogs seemed to have improved range of motion and control of their limbs.

The dogs have since been adopted, and continue to do well at their home in New Mexico.

Spina bifida occurs when spinal tissue improperly fuses in utero, causing a range of cognitive, mobility, urinary and bowel disabilities in about 1,500 to 2,000 children born in the U.S. each year. The dogs procedure, which involved surgical techniques developed byfetal surgeon Diana Farmerof UC Davis Health together with a cellular treatment developed by stem cell scientistsAijun WangandDori Borjesson, director of the universitysVeterinary Institute for Regenerative Cures, represents a major step toward curing spina bifida for both humans and dogs.

Farmer pioneered the use of surgery prior to birth to improve brain development in children with spina bifida. She later showed that prenatal surgery combined with human placenta-derived mesenchymal stromal cells (PMSCs), held in place with a cellular scaffold, helped research lambs born with the disorder walk without noticeable disability.

Sturges wanted to find out if the surgery-plus-stem-cell approach could give dogs closer-to-normal lives along with better chances of survival and adoption. At 10-weeks old, Darla and Spanky were transported from Southern California Bulldog Rescue to the UC Davis veterinary hospital, where they were the first dogs to receive the treatment, this time using canine instead of human PMSCs.

Another distinction for Darla and Spanky is that their treatment occurred after birth, since prenatal diagnosis of spina bifida is not performed on dogs, Sturges explained. The disorder becomes apparent between 1 and 2 weeks of age, when puppies show hind-end weakness, poor muscle tone, incoordination and abnormal use of their tails.

UC Davis is the only place where this type of cross-disciplinary, transformational medicine could happen, according to Farmer.

Its rare to have a combination of excellent medical and veterinary schools and strong commitment to advancing stem cell science at one institution, she said.

UC Davis is also home to the One Healthinitiative aimed at finding novel treatmentslike thesefor diseases that affect both humans and animals.

Ive often said that I have the greatest job on the planet, because I get to help kids, Farmer said. Now my job is even better, because I get to help puppies too.

With additional evaluation and U.S. Food and Drug Administration approval, Farmer and Wang hope to test the therapy in human clinical trials. Sturges and Borjesson hope to do the same with a canine clinical trial. They hope the outcomes of their work help eradicate spina bifida in dogs and humans.

In the meantime, the team wants dog breeders to send more puppies with spina bifida to UC Davis for treatment and refinements that help the researchers fix an additional hallmark of spina bifida incontinence. While Darla and Spanky are very mobile and doing well on their feet, they still require diapers.

Further analysis of their progress will determine if the surgery improves their incontinence conditions, Sturges said.

Funding for this project was provided by the Veterinary Institute for Regenerative Cures (VIRC) at the UC Davis School of Veterinary Medicine, and the Surgical Bioengineering Lab at the UC Davis School of Medicine. Private donations to the veterinary school for stem cell research also contributed to this procedure. Farmer and Wangs spina bifida research is supported by funding from the National Institutes of Health, the California Institute for Regenerative Medicine, Shriners Hospitals for Children and the March of Dimes Foundation.

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Puppies benefit from stem cell treatment for children with spina bifida - University of California

Why Doug Baldwin went to England for stem-cell therapy – The News Tribune (blog)

Stem Cell Medicine | Posted by admin
Aug 29 2017

The News Tribune (blog)
Why Doug Baldwin went to England for stem-cell therapy
The News Tribune (blog)
RENTON Turns out, Doug Baldwin started this current Seahawks fad of traveling outside the team's normal medical coverage to get far-flung treatment using body cells. The Seahawks' No. 1 wide receiver told me Monday he went overseas before this season ...

and more »

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Why Doug Baldwin went to England for stem-cell therapy - The News Tribune (blog)

FDA moves to curb dangerous stem cell clinics – Philly.com

Stem Cell Medicine | Posted by admin
Aug 29 2017

The U.S. Food and Drug Administration on Monday announced a crackdown on deceptive and dangerous stem cell clinics, starting with actions against a California company accused of giving smallpox vaccine to cancer patients, and a Florida company that ruined the eyesight of three women.

Our actions today should also be a warning to others who may be doing similar harm, FDA Commissioner Scott Gottlieb said in a statement, urging consumers and health-care providers to report rogue clinics and injuries.

FDA Commissioner Scott Gottlieb

The California company, San Diego-based StemImmune Inc., was combining the vaccine with stem cells derived from fat, then giving it intravenously or injecting it into tumors of cancer patients at clinics in Rancho Mirage and Beverly Hills, Calif., the FDA said.

U.S. marshals on Friday seized five vials of smallpox vaccine, including one that was partially used. The agency is investigating how the company obtained the vaccine, which has been stockpiled by the government in case of a bioterrorist attack.

The vaccine is made with live vaccinia virus, a poxvirus similar to but less harmful than smallpox. The vaccine could cause life-threatening problems in immune-compromised cancer patients, and alsoin certain unvaccinated people who might be accidentally infected by the patients, the FDA explained.

Speaking as a cancer survivor, Gottlieb said in a statement, I know all too well the fear and anxiety the diagnosis of cancer can have and how tempting it can be to believe the hollow claims made by these kinds of unscrupulous clinics. The FDA will not allow deceitful actors to take advantage of vulnerable patients.

In a separate enforcement action, the FDA sent a warning letter last week to U.S. Stem Cell Clinic of Sunrise, Fla., saying it could face product seizure or an injunction. Agency inspectors found that the clinic was processing fat-derived stem cells and claiming to treat a raft of conditions, including Parkinsons disease, amyotrophic lateral sclerosis (ALS), rheumatoid arthritis, diabetes, and heart failure.

In March, U.S. Stem Cell made headlines when an article in the New England Journal of Medicine reported that three women with age-related macular degeneration suffered severe and permanent vision damage one was blinded after stem cells were injected into their eyeballs at the clinic. The article was written by doctors unconnected with the clinic who treated the women for the disastrous results.

Critics of unapproved stem cell treatments have called for tougher oversight by the FDA, as well as by the Federal Trade Commission, which regulates advertising, and by state medical boards, which oversee the practice of medicine.

The regulatory moves come as so-called regenerative medicine is exploding, spawning an industry built on unproven treatments using stem cells from bone marrow or fat. In recent months, networks of chiropractors have run big-budget ads for such treatments in newspaper across the country, including the Inquirer. Those ads, however, focus on addressing orthopedic problems such as degenerative discs and arthriticknees.

The only FDA-approved stem cell therapies involve using cells from bone marrow or umbilical cord blood to treat blood cancers and certain immune disorders. In general, biologic tissues that are processed and marketed as therapies are supposed to go through the FDAs drug approval process, which involves years of costly clinical testing in humans.

However, the FDA has tried to find a middle ground, recognizing the potential promise of stem cells in tissue repair and regeneration. The FDA has published, but has not finalized, draft guidance for stem cell products, saying they can be exempted from the drug approval process under certain scenarios. Among other criteria, the cells must be minimally manipulated and used in a homologous way, meaning for the same function they perform naturally in the body.

In a policy statement issued Monday, Gottlieb promised that this fall, the agency will advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field. It will enable responsible product developers to gain FDAapproval with minimal burdens and costs.

We want to facilitate innovation, he wrote.

Published: August 28, 2017 4:42 PM EDT

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FDA moves to curb dangerous stem cell clinics - Philly.com

Stem Cell Treatment Helps Puppies With Spina Bifida – Technology Networks

Stem Cell Medicine | Posted by admin
Aug 29 2017

A pair of English bulldog puppies are the first patients to be successfully treated with a unique therapy a combination of surgery and stem cells developed at the University of California, Davis, to help preserve lower-limb function in children with spina bifida.

Because dogs with the birth defect frequently have little control of their hindquarters, they also have little hope for a future. They are typically euthanized as puppies.

At their postsurgery re-check at 4 months old, however, the siblings, named Darla and Spanky, showed off their abilities to walk, run and play to their doctor, veterinary neurosurgeon Beverly Sturges.

The initial results of the surgery are promising, as far as hind limb control, said Sturges. Both dogs seemed to have improved range of motion and control of their limbs.

The dogs have since been adopted, and continue to do well at their home in New Mexico.

A major step toward curing spina bifida

Spina bifida occurs when spinal tissue improperly fuses in utero, causing a range of cognitive, mobility, urinary and bowel disabilities in about 1,500 to 2,000 children born in the U.S. each year. The dogs procedure, which involved surgical techniques developed by fetal surgeon Diana Farmer of UC Davis Health together with a cellular treatment developed by stem cell scientists Aijun Wang and Dori Borjesson, director of the universitys Veterinary Institute for Regenerative Cures, represents a major step toward curing spina bifida for both humans and dogs.

Farmer pioneered the use of surgery prior to birth to improve brain development in children with spina bifida. She later showed that prenatal surgery combined with human placenta-derived mesenchymal stromal cells (PMSCs), held in place with a cellular scaffold, helped research lambs born with the disorder walk without noticeable disability.

Sturges wanted to find out if the surgery-plus-stem-cell approach could give dogs closer-to-normal lives along with better chances of survival and adoption. At 10-weeks old, Darla and Spanky were transported from Southern California Bulldog Rescue to the UC Davis veterinary hospital, where they were the first dogs to receive the treatment, this time using canine instead of human PMSCs.

Another distinction for Darla and Spanky is that their treatment occurred after birth, since prenatal diagnosis of spina bifida is not performed on dogs, Sturges explained. The disorder becomes apparent between 1 and 2 weeks of age, when puppies show hind-end weakness, poor muscle tone, incoordination and abnormal use of their tails.

A unique environment for collaborative research

UC Davis is the only place where this type of cross-disciplinary, transformational medicine could happen, according to Farmer.

Its rare to have a combination of excellent medical and veterinary schools and strong commitment to advancing stem cell science at one institution, she said.

UC Davis is also home to the One Health initiative aimed at finding novel treatments like these for diseases that affect both humans and animals.

Ive often said that I have the greatest job on the planet, because I get to help kids, Farmer said. Now my job is even better, because I get to help puppies too.

Hopes for clinical trials in humans and dogs

With additional evaluation and U.S. Food and Drug Administration approval, Farmer and Wang hope to test the therapy in human clinical trials. Sturges and Borjesson hope to do the same with a canine clinical trial. They hope the outcomes of their work help eradicate spina bifida in dogs and humans.

In the meantime, the team wants dog breeders to send more puppies with spina bifida to UC Davis for treatment and refinements that help the researchers fix an additional hallmark of spina bifida incontinence. While Darla and Spanky are very mobile and doing well on their feet, they still require diapers.

Further analysis of their progress will determine if the surgery improves their incontinence conditions, Sturges said.

Funding for this project was provided by the Veterinary Institute for Regenerative Cures (VIRC) at the UC Davis School of Veterinary Medicine, and the Surgical Bioengineering Lab at the UC Davis School of Medicine. Private donations to the veterinary school for stem cell research also contributed to this procedure. Farmer and Wangs spina bifida research is supported by funding from the National Institutes of Health, the California Institute for Regenerative Medicine, Shriners Hospitals for Children and the March of Dimes Foundation.

This article has been republished frommaterialsprovided byUC Davis. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Stem Cell Treatment Helps Puppies With Spina Bifida - Technology Networks

ICMR’s stem cell research guidelines soon to be released – ETHealthworld.com

Stem Cell Medicine | Posted by admin
Aug 29 2017

Representative imageBy Priyanka V Gupta

New Delhi: Indian Council of Medical Research (ICMR) will soon release the final document on guidelines for stem cell research, the draft of which was available on the ICMR and the DBT (Department of Biotechnology) websites for public reviews till July 31 this year. The guidelines are expected to help in curbing the unethical practices in regenerative medicine. The information was shared by Dr Geeta Jotwani, deputy director general, ICMR, at a recent event where MoU was signed between ABLE (Association of Biotechnology Led Enterprise) and FIRM (Forum for Innovative Regenerative Medicine) for industry research collaborations.

Dr Jotwani said, On the directives of DCGI (Drug Controller General of India), ICMR has been framing the guidelines for stem cell research and therapy since 2001. Unfortunately, there is no therapy available other than bone marrow transplantation, for which also no standard of care has been laid out. In that direction, we have been making periodic efforts by releasing the guideline documents in 2002, 2007, 2013 and now the updated documentation for 2017 is under finalization.

ICMR has been proactively working towards educating the stakeholders about the ethical practices in stem cell research and therapy, for which a special committee, called National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT), has been formed to advise the scientists community. Regenerative medicine is an innovative science. As part of ICMR, more research is involved than getting into conclusion that we are ready for application. We are proactively making efforts to educate, create awareness and give directions to our scientists community and clinicians on how they should go about the research part of stem cell therapy, said Dr Jotwani.

There are many clinicians entering into unethical practices and promising general public about the available care in almost all sorts of incurable conditions, including autism, according to Dr Jotwani.

She said, We are always concerned about what the end users are getting and the promises that are being made to them. Hence, we are proactively being involved in interacting with different government agencies as well as the industry to curb the unethical practices for which we also established NAC-SCRT under the Department of Health Research, Government of India. The committee, which comprises of different government agencies as well as ethics and social groups, legal experts, representatives of drug controllers office and CDSCO (Central Drug Standard Control Organization), deliberates on the issues of upcoming technologies and takes proactive role in the regenerative medicine.

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ICMR's stem cell research guidelines soon to be released - ETHealthworld.com