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Category Archives: New Jersey Stem Cells

Blood Donations Needed Pre and Post Labor Day Holiday – East … – TAPinto.net

Posted: August 29, 2017 at 4:47 pm

NEW JERSEY - New Jersey Blood Services (NJBS), a division of New York Blood Center (NYBC), is urging the public to donate blood as we head into the Labor Day holiday. New Jersey roads are packed with cars heading to the beach and the mountains. With so many people on vacation, blood donations drop significantly the last week of August into the first ten days of September as parents and students prepare for the start of the school year.

The need for blood never takes a holiday. Blood donations are urgently needed this time of year. Not only do we see fewer blood donations, but fewer blood drives are scheduled during this two week period. Patients in local hospitals still need blood for emergencies and regular treatments, however.

NYBC announced a blood emergency in late June which lasted much of the summer. Raising awareness for this critical Labor Day holiday period will help boost blood donations and rebuild the inventory.

Sign Up for E-News

O negative blood donors are considered universal, and their blood type is needed most readily in trauma situations and emergency departments across the country. Due to its high demand, O negative blood is in short supply and NYBC encourages individuals with this blood type to donate today. Our local blood supply has reached a critically low level, with under a two-day supply of O negative, B negative, and A negative.

To donate blood or for information on how to organize a blood drivePlease call Toll Free: 1-800-933-2566Visit: http://www.nybloodcenter.org/blood

In order to maintain a safe blood supply a seven-day inventory of all types must be continually replenished. Companies, organizations, and community groups are also encouraged to step up to host a blood drive in September to help rebuild the blood supply. Hosting a blood drive is easy and NYBCs staff will help every step of the way.

More About Blood Donations

The entire donation process takes less than an hour and a single donation can be used to save multiple lives. Donors with O-negative blood type, or universal donors, are especially encouraged to donate, as their blood can be used in emergencies. Nearly 2,000 donations are needed each day in New York and New Jersey alone. About one in seven hospital admissions requires a blood transfusion, and with a limited shelf life, supplies must be continually replenished.

If you cannot donate but still wish to participate in bringing crucial blood products to patients in need, please consider hosting a blood drive or volunteering at a local blood drive.

Any company, community organization, place of worship, or individual may host a blood drive. Blood donors receive free mini-medical exams on site including information about their temperature, blood pressure and hematocrit level. Eligible donors include those people at least age 16 (parental consent is required for 16-year-olds), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People age 76 or older may donate if they have a doctors note on file with New York Blood Center or if they bring one on the day of the blood drive.

About New York Blood Center

Now more than 50 years old, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. NYBCs mission is to serve the 20 million people in the New York metropolitan area and more broadly, our nation and our world by alleviating human suffering and preserving human life using our medical expertise.

Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the worlds largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which among other milestones developed the hepatitis B vaccine and innovative blood purification technology.

Website: nybc.org

Facebook: http://www.facebook.com/newyorkbloodcenter

Twitter: @NYBloodCenter

Instagram: @newyorkbloodcenter

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Blood Donations Needed Pre and Post Labor Day Holiday - East ... - TAPinto.net

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Blood Donations Needed During Labor Day Holiday Season – TAPinto – TAPinto.net

Posted: August 29, 2017 at 4:47 pm

New Jersey Blood Services (NJBS), a division of New York Blood Center (NYBC), is urging the public to donate blood as we head into the Labor Day holiday. New Jersey roads are packed with cars heading to the beach and the mountains. With so many people on vacation, blood donations drop significantly the last week of August into the first ten days of September as parents and students prepare for the start of the school year.

The need for blood never takes a holiday. Blood donations are urgently needed this time of year. Not only do we see fewer blood donations, but fewer blood drives are scheduled during this two week period. Patients in local hospitals still need blood for emergencies and regular treatments, however.

NYBC announced a blood emergency in late June which lasted much of the summer. Raising awareness for this critical Labor Day holiday period will help boost blood donations and rebuild the inventory.

Sign Up for E-News

O negative blood donors are considered universal, and their blood type is needed most readily in trauma situations and emergency departments across the country. Due to its high demand, O negative blood is in short supply and NYBC encourages individuals with this blood type to donate today. Our local blood supply has reached a critically low level, with under a two-day supply of O negative, B negative, and A negative.

To donate blood or for information on how to organize a blood drivePlease call Toll Free: 1-800-933-2566Visit: http://www.nybloodcenter.org/blood

In order to maintain a safe blood supply a seven-day inventory of all types must be continually replenished. Companies, organizations, and community groups are also encouraged to step up to host a blood drive in September to help rebuild the blood supply. Hosting a blood drive is easy and NYBCs staff will help every step of the way.

More About Blood Donations

The entire donation process takes less than an hour and a single donation can be used to save multiple lives. Donors with O-negative blood type, or universal donors, are especially encouraged to donate, as their blood can be used in emergencies. Nearly 2,000 donations are needed each day in New York and New Jersey alone. About one in seven hospital admissions requires a blood transfusion, and with a limited shelf life, supplies must be continually replenished.

If you cannot donate but still wish to participate in bringing crucial blood products to patients in need, please consider hosting a blood drive or volunteering at a local blood drive.

Any company, community organization, place of worship, or individual may host a blood drive. Blood donors receive free mini-medical exams on site including information about their temperature, blood pressure and hematocrit level. Eligible donors include those people at least age 16 (parental consent is required for 16-year-olds), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People age 76 or older may donate if they have a doctors note on file with New York Blood Center or if they bring one on the day of the blood drive.

About New York Blood Center

Now more than 50 years old, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. NYBCs mission is to serve the 20 million people in the New York metropolitan area and more broadly, our nation and our world by alleviating human suffering and preserving human life using our medical expertise.

Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the worlds largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which among other milestones developed the hepatitis B vaccine and innovative blood purification technology.

Website: nybc.org

Facebook: http://www.facebook.com/newyorkbloodcenter

Twitter: @NYBloodCenter

Instagram: @newyorkbloodcenter

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Lab-made "mini organs" helping doctors treat cystic fibrosis – New Jersey Herald

Posted: August 29, 2017 at 4:47 pm

Posted: Aug. 23, 2017 8:00 am Updated: Aug. 23, 2017 12:30 pm

UTRECHT, Netherlands (AP) Els van der Heijden, who has cystic fibrosis, was finding it ever harder to breathe as her lungs filled with thick, sticky mucus. Despite taking more than a dozen pills and inhalers a day, the 53-year-old had to stop working and scale back doing the thing she loved best, horseback riding.

Doctors saw no sense in trying an expensive new drug because it hasn't been proven to work in people with the rare type of cystic fibrosis that van der Heijden had.

Instead, they scraped a few cells from van der Heijden and used them to grow a mini version of her large intestine in a petri dish. When van der Heijden's "mini gut" responded to treatment, doctors knew it would help her too.

"I really felt, physically, like a different person," van der Heijden said after taking a drug and getting back in the saddle.

This experiment to help people with rare forms of cystic fibrosis in the Netherlands aims to grow mini intestines for every Dutch patient with the disease to figure out, in part, what treatment might work for them. It's an early application of a technique now being worked on in labs all over the world, as researchers learn to grow organs outside of the body for treatment and maybe someday for transplants.

So far, doctors have grown mini guts just the size of a pencil point for 450 of the Netherlands' roughly 1,500 cystic fibrosis patients.

"The mini guts are small, but they are complete," said Dr. Hans Clevers of the Hubrecht Institute, who pioneered the technique. Except for muscles and blood vessels, the tiny organs "have everything you would expect to see in a real gut, only on a really small scale."

These so-called organoids mimic features of full-size organs, but don't function the same way. Although many of the tiny replicas are closer to undeveloped organs found in an embryo than adult ones, they are helping scientists unravel how organs mature and providing clues on how certain diseases might be treated.

In Australia, mini kidneys are being grown that could be used to test drugs. Researchers in the U.S. are experimenting with tiny bits of livers that might be used to boost failing organs. At Cambridge University in England, scientists have created hundreds of mini brains to study how neurons form and better understand disorders like autism. During the height of the Zika epidemic last year, mini brains were used to show the virus causes malformed brains in babies.

In the Netherlands, the mini guts are used as a stand-in for cystic fibrosis patients to see if those with rare mutations might benefit from a number of pricey drugs, including Orkambi. Made by Vertex Pharmaceuticals, Orkambi costs about 100,000 euros per patient every year in some parts of Europe, and it's more than double that in the U.S., which approved the drug in 2015. Despite being initially rejected by the Dutch government for being too expensive, negotiations with Vertex were reopened in July.

Making a single mini gut and testing whether the patient would benefit from certain drugs costs a couple of thousand euros. The program is paid for by groups including health insurance companies, patient foundations and the government. The idea is to find a possible treatment for patients, and avoid putting them on expensive drugs that wouldn't work for them.

About 50 to 60 patients across the Netherlands have been treated after drugs were tested on organoids using their cells, said Dr. Kors van der Ent, a cystic fibrosis specialist at the Wilhelmina Children's Hospital, who leads the research.

Clevers made a discovery about a decade ago that got researchers on their way. They found pockets of stem cells, which can turn into many types of other cells, in the gut. They then homed in a growing environment in the lab that spurred these cells to reproduce rapidly and develop.

"To our surprise, the stem cells started building a mini version of the gut," Clevers recalled.

Cystic fibrosis is caused by mutations in a single gene that produces a protein called CFTR, responsible for balancing the salt content of cells lining the lungs and other organs.

To see if certain drugs might help cystic fibrosis patients, the medicines are given to their custom-made organoids in the lab. If the mini organs puff up, it's a sign the cells are now correctly balancing salt and water. That means the drugs are working, and could help the patient from whom the mini gut was made.

Researchers are also using the mini guts to try another approach they hope will someday work in people using a gene editing technique to repair the faulty cystic fibrosis gene in the organoid cells.

Other experiments are underway in the Netherlands and the U.S. to test whether organoids might help pinpoint treatments for cancers involving lungs, ovaries and pancreas.

While the idea sounds promising, some scientists said there are obstacles to using mini organs to study cancer.

Growing a mini cancer tumor, for example, would be far more challenging because scientists have found it difficult to make tumors in the lab that behave like in real life, said Mathew Garnett of the Wellcome Trust Sanger Institute, who has studied cancer in mini organs but is not connected to Clevers' research.

Also, growing the cells and testing them must happen faster for cancer patients who might not have much time to live, he said.

Meanwhile, Clevers wants to one day make organs that are not so mini.

"My dream would be to be able to custom-make organs," he said, imagining a future where doctors might have a "freezer full of livers" to choose from when sick patients arrive.

Others said while such a vision is theoretically possible, huge hurdles remain.

"There are still enormous challenges in tissue engineering with regards to the size of the structure we're able to grow," said Jim Wells, a pediatrics professor at the Cincinnati Children's Hospital Medical Center. He said the mini organs are far smaller than what would be needed to transplant into people and it's unclear if scientists can make a working, life-sized organ in the lab.

There are other limitations to growing miniature organs in a dish, said Madeline Lancaster at Cambridge University.

"We can study physical changes and try to generate drugs that could prevent detrimental effects of disease, but we can't look at the complex interplay between organs and the body," she said.

For patients like van der Heijden, who was diagnosed with cystic fibrosis as a toddler, the research has helped her regain her strength. Vertex agreed to supply her with the drug.

"It was like somebody opened the curtains and said, 'Sunshine, here I am, please come out and play.'" she said. "It's strange to think this is all linked to some of my cells in a lab."

___

This Associated Press series was produced in partnership with the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

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Blood Donations Needed During Labor Day Holiday Season – TAPinto.net

Posted: August 29, 2017 at 4:47 pm

New Jersey Blood Services (NJBS), a division of New York Blood Center (NYBC), is urging the public to donate blood as we head into the Labor Day holiday. New Jersey roads are packed with cars heading to the beach and the mountains. With so many people on vacation, blood donations drop significantly the last week of August into the first ten days of September as parents and students prepare for the start of the school year.

The need for blood never takes a holiday. Blood donations are urgently needed this time of year. Not only do we see fewer blood donations, but fewer blood drives are scheduled during this two week period. Patients in local hospitals still need blood for emergencies and regular treatments, however.

NYBC announced a blood emergency in late June which lasted much of the summer. Raising awareness for this critical Labor Day holiday period will help boost blood donations and rebuild the inventory.

Sign Up for E-News

O negative blood donors are considered universal, and their blood type is needed most readily in trauma situations and emergency departments across the country. Due to its high demand, O negative blood is in short supply and NYBC encourages individuals with this blood type to donate today. Our local blood supply has reached a critically low level, with under a two-day supply of O negative, B negative, and A negative.

To donate blood or for information on how to organize a blood drivePlease call Toll Free: 1-800-933-2566Visit: http://www.nybloodcenter.org/blood

In order to maintain a safe blood supply a seven-day inventory of all types must be continually replenished. Companies, organizations, and community groups are also encouraged to step up to host a blood drive in September to help rebuild the blood supply. Hosting a blood drive is easy and NYBCs staff will help every step of the way.

More About Blood Donations

The entire donation process takes less than an hour and a single donation can be used to save multiple lives. Donors with O-negative blood type, or universal donors, are especially encouraged to donate, as their blood can be used in emergencies. Nearly 2,000 donations are needed each day in New York and New Jersey alone. About one in seven hospital admissions requires a blood transfusion, and with a limited shelf life, supplies must be continually replenished.

If you cannot donate but still wish to participate in bringing crucial blood products to patients in need, please consider hosting a blood drive or volunteering at a local blood drive.

Any company, community organization, place of worship, or individual may host a blood drive. Blood donors receive free mini-medical exams on site including information about their temperature, blood pressure and hematocrit level. Eligible donors include those people at least age 16 (parental consent is required for 16-year-olds), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People age 76 or older may donate if they have a doctors note on file with New York Blood Center or if they bring one on the day of the blood drive.

About New York Blood Center

Now more than 50 years old, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. NYBCs mission is to serve the 20 million people in the New York metropolitan area and more broadly, our nation and our world by alleviating human suffering and preserving human life using our medical expertise.

Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the worlds largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which among other milestones developed the hepatitis B vaccine and innovative blood purification technology.

Website: nybc.org

Facebook: http://www.facebook.com/newyorkbloodcenter

Twitter: @NYBloodCenter

Instagram: @newyorkbloodcenter

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Taconic, Silverstein to build 150000 s/f life science research center – Real Estate Weekly

Posted: August 29, 2017 at 4:47 pm

Taconic Investment Partners and Silverstein Properties announced development plans for the building at 619 West 54th Street, to be named the Hudson Research Center, which includes the creation of over 150,000 s/f of life science wet lab research space.

619 West 54th Street, the home of the New York Stem Cell Foundations recently developed 40,000 s/f research institute and headquarters, features the infrastructure necessary to support life science and medical tenants including 33,000 s/f floorplates, robust electrical capacity, emergency generators, high floor loads, and high ceilings.

In addition, Taconic and Silverstein have plans to invest up to $20 million to further enhance base building infrastructure in order to deliver lab-ready space to research tenants.

New York City has all of the assets to become a major life science hub including world-class medical research institutions, a depth of research talent, presence of big pharmaceutical companies and venture capital, and with recent life science initiatives launched from both New York City and New York State, we feel New York is poised to join cities like Boston and the San Francisco Bay Area as the next big research cluster, said Matthew Weir, vice president of Taconic.

We are offering lab-ready space to a severely supply-constrained market and when combined with the New York Stem Cell Foundation facility in the building, we have the beginnings of a dynamic new life science hub.

The Hudson Research Center contains a total of 330,000 s/f spread over 10 stories and features natural light from multiple exposures and unobstructed views of the Hudson River and the Midtown Manhattan skyline.

Located across from DeWitt Clinton Park, the buildings amenities include onsite gated parking, and a new bike storage and shower facility.

The New York Stem Cell Foundation (NYSCF) opened its Research Institute in April. The facility is one of the largest laboratories in the world devoted to stem cell research.

The glass-enclosed wet lab includes the most advanced technology available for the manufacturing and study of stem cells. The facility includes molecular biology, imaging, and cell sorting and will have a highly-specialized GMP facility.

We are delighted to partner with Taconic to reposition this historic building, said Marty Burger, Chief Executive Officer of Silverstein Properties. Life sciences are a priority for the Governor and the Mayor and research tenants now have the perfect home on the west side of Manhattan.

The landlord has retained Transwestern Consulting Group (TCG) as the exclusive leasing agent for the building. New York City has emerged as a cluster location for the life science industry, said Steve Purpura, TCGs Northeast Market Leader. Hudson Research Centers location is going to be an attractive alternative for the many growing biotech companies looking to tap into the large life science labor pools in New Jersey and Long Island.

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Stem Cell Center Of NJ – New Jersey Stem Cell Therapy

Posted: August 24, 2017 at 5:44 am

Shoulder Pain

Shoulder pain from injuries can either be acute or chronic. Regenerative medicine is an emerging field, which offers a non-surgical option that commonly uses the patients own stem cells, exosomes, and other sources of growth factors to regenerate healthy tissue.

Your back pain has finally caught up with you and youre struggling to reverse the damage. However, regenerative medicine is an emerging field, which offers a non-surgical option that commonly uses the patients own stem cells, exosomes, and other sources of growth factors to regenerate healthy tissue.

If knee pain is derailing your active lifestyle or even your daily activities, then youre not alone. Regenerative medicine is an emerging field, which offers a non-surgical option that commonly uses the patients own stem cells, exosomes, and other sources of growth factors to regenerate healthy tissue.

Pain can strike in a few locations around the hip. Regenerative medicine is an emerging field, which offers a non-surgical option that commonly uses the patients own stem cells, exosomes, and other sources of growth factors to regenerate healthy tissue.

NERVE INJURIES pain doesnt fade, your health care provider may recommend surgery to reverse the damage. However, regenerative medicine is an emerging field, which offers a non-surgical option that commonly uses the patients own stem cells, exosomes, and other sources of growth factors to regenerate healthy tissue.

To understand neuropathy, it helps to understand how the nervous system works. Regenerative medicine is an emerging field, which offers a non-surgical option that commonly uses the patients own stem cells, exosomes, and other sources of growth factors to regenerate healthy tissue.

Erectile Dysfunction (ED) is the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse. Regenerative medicine is an emerging field, which offers a non-surgical option that commonly uses the patients own stem cells, exosomes, and other sources of growth factors to regenerate healthy tissue.

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Stem Cell Center Of NJ - New Jersey Stem Cell Therapy

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Celularity, Inc., Accelerates Breakthrough Placental Discovery & Therapeutic Platform – TASS

Posted: August 24, 2017 at 5:44 am

Celularity has been created through the contributions of extensive intellectual property, clinical-stage assets, basic and clinical research, and development expertise including:

Founded on the pioneering work of Robert Hariri, MD, PhD, in human placenta-derived cellular therapeutics and biomaterials, Celularity's ability to procure placental stem cells, engineer potential therapies, and deploy potential treatments, positions it to harness the potential of the human placenta and operate along the entire value chain.

"Celularity was formed as a new biotechnology model designed to apply the necessary expertise to harness our placenta discovery platform across a range of unmet medical needs," said Celularity Founder and Chief Executive Officer, Robert J. Hariri, MD, PhD. "With the support of our investors, we are assembling proven regenerative medicine technology and expertise with the goal of developing transformative therapies for fatal and intractable diseases." Dr. Hariri was previously chairman, chief scientific officer and chief executive officer of Celgene Cellular Therapeutics and founder of Anthrogenesis Corporation, which Celgene acquired in 2002. Dr. Hariri is also the co-founder of Human Longevity, Inc.

The formation of Celularity leverages seminal work in the discovery of novel biologically active cell populations in the human placenta with broad therapeutic potential. Celularity will draw upon these proprietary and scalable discoveries that derive from the post-partum human placenta an ethical and renewable source of usable biomaterials. Celularity's development program is focused on an allogeneic platform, leveraging clinically accessible, immune-tolerant cells and biomaterials from a diverse population of informed-consent donors.

Andrew von Eschenbach, MD, among the founding members of the Celularity Board of Directors and former United States Food and Drug Administration (FDA) Commissioner and Director of the National Cancer Institute said, "The pioneering work of Celularity founder Bob Hariri has unleashed the unique properties of placental derived stem cells which have renewed hope for creating safe and effective therapies for the most challenging degenerative diseases." Dr. von Eschenbach added "Celularity with its focus on accelerating innovation in regenerative medicine can become the leading catalyst for cell therapy to address many of the world's unmet medical needs."

Dr. Henry Ji, President and CEO of Sorrento Therapeutics, said, "We are very excited to participate in the creation of Celularity together with Dr. Hariri and his scientific team as well as global leading biopharmaceutical companies, such as Celgene, Human Longevity Inc., and United Therapeutics. The potential for regenerative therapies in treating a wide array of chronic degenerative conditions is well known. We see important synergies for the oncology field and the potential to enhance our fight against malignant cancers. Celularity's technologies, assets, and resources will help advance selected Sorrento cellular therapy programs and potentially transform autologous cellular therapies into affordable and accessible allogeneic cell therapies."

*Interfyl is a registered trademark of Alliqua BioMedical, Inc.

About Celularity, Inc.Celularity, headquartered in Warren, New Jersey, is a biotechnology company with proprietary, leading-edge technology and Intellectual Property to harness the power of the placenta. Their medicine asset portfolio consists of more than 200 issued or pending patents as well as pre-clinical and clinical assets including CAR constructs for allogeneic CAR-T/NK products, licenses of 100+ immunotherapy assets, and commercial stage biosourcing and functional regeneration businesses. For more information, please visitwww.celularity.com. Follow Celularity on Social Media:@Celularity.

About United TherapeuticsUnited Therapeutics Corporationis a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions.

About Sorrento TherapeuticsSorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for immuno-oncology, inflammation and autoimmune diseases. Sorrento's lead product candidates include immunotherapies focused on the treatment of both solid tumors and hematological malignancies, as well as late stage pain products. For more information, please visithttp://sorrentotherapeutics.com

About Human Longevity, Inc.Human Longevity, Inc. (HLI) is the genomics-based, health intelligence company creating the world's largest and most comprehensive database of whole genome, phenotype and clinical data. HLI is developing and applying large scale computing and machine learning to make novel discoveries to revolutionize health. In addition to the HLIQ Whole Genome and HLIQ Oncology, HLI's business also includes the HLI Health Nucleus, a genomic powered clinical research center which uses whole genome sequence analysis, advanced clinical imaging and innovative machine learning, along with curated personal health information, to deliver the most complete picture of individual health. For more information, please visithttp://www.humanlongevity.comorhttp://www.healthnucleus.com

Media Contacts:CelularityOlivia GoodmanPhone: 212 715-1597olivia.goodman@finnpartners.com

Sorrento Therapeutics, Inc.Alexis Nahama, DVMPhone: 858 203-4120anahama@sorrentotherapeutics.com

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FDA OKs Pfizer drug for rare, fast-killing type of leukemia – New Jersey Herald

Posted: August 24, 2017 at 5:44 am

Posted: Aug. 17, 2017 8:00 am Updated: Aug. 17, 2017 5:35 pm

TRENTON, N.J. (AP) The Food and Drug Administration has approved a new medicine for use against a rare, rapidly progressing blood cancer after other treatments have failed.

The agency approved Pfizer Inc.'s Besponsa for patients with a type of advanced acute lymphoblastic leukemia. By then, life expectancy is low.

"These patients have few treatments available and today's approval provides a new, targeted treatment option," Dr. Richard Pazdur, the FDA's director for cancer drugs, said in a statement.

This year an estimated 5,970 Americans will be diagnosed and 1,440 will die from the cancer, according to the National Cancer Institute.

The drug will cost $168,300 without insurance for the typical nine-week treatment course.

In testing that included 218 patients, 36 percent given Besponsa had their cancer vanish for eight months on average; 17 percent of those given chemotherapy had complete remission for a median five months.

Besponsa is believed to work by blocking the growth of cancerous cells by binding to their surface.

The powerful injected drug, known chemically as inotuzumab ozogamicin, comes with the FDA's most-stringent warning because it can cause severe liver disease, including blocking veins in the liver. It also carries an increased risk of death in patients who have received a certain type of stem cell transplant.

Besponsa also can cause a decrease in blood-cell and platelet production, infusion-related reactions and problems with the heart's electrical pulses. Women who are pregnant or breastfeeding should not take Besponsa because it may harm a developing fetus or a newborn baby, the FDA warned.

More-common side effects include fatigue, severe bleeding, fever, nausea and headaches.

___

Follow Linda A. Johnson at http://www.twitter.com/LindaJ_onPharma

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WCT selected to conduct Ph III NurOwn Trial in ALS – OutSourcing-Pharma.com

Posted: July 6, 2017 at 5:43 am

BrainStorm Cell Therapeutics has contracted Worldwide Clinical Trials (WCT) to conduct its planned Phase III study of NurOwn in the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm Cell Therapeutics is developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases.

According to New Jersey-based company, a study kick-off meeting is expected later this month.

The company has an exclusive, worldwide licensing agreement with Ramon, Tel Aviv Universitys technology transfer company, through which it holds the rights to develop and commercialize the NurOwn technology.

NurOwn previously demonstrated a clinically meaningful benefit of the technology in a randomized, double-blind, placebo-controlled clinical trial conducted in the US.

Subsequently, Brainstorm will conduct a randomized, double-blind, placebo-controlled multi-dose Phase III trial at multiple sites with support from WCT.

Chaim Lebovits, BrainStorm Cell Therapeutics CEO said selecting a contract research organization (CRO) is a critical step before initiating patient enrollment into the companys Phase III study of NurOwn.

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Blood Drive To Honor 2 1/2-year-old Brain Tumor Patient, 4-year-old Lymphoma Patient – TAPinto.net

Posted: July 6, 2017 at 5:43 am

New Jersey Blood Services (NJBS), a division of New York Blood Center (NYBC), is asking the community to donate blood on Thursday, July 20 in honor of 2 1/2-year-old brain tumor victim, Gracie Skuches and 4-year-old Lymphoma patient, Alex Hammer. The Blood Drive in Honor of Grace & Alex will be held from 2pm - 8pm at the Knights of Columbus Hall, 79 Pascack Road, Township of Washington, NJ. Visit http://www.nybc.org and use group code 68937 to make an appointment. Walkins are also welcome.

The New York Blood Center has declared a Blood Emergency. With less than a days supply on hand of some blood types, NJBS is appealing to the community to donate in honor of Gracie and Alex and other cancer victims in area hospitals.

At 6 months old, Gracie was diagnosed with Atypical Teratoid/Rhabdiod Tumor (ATRT), an extremely rare, very difficult to treat pediatric brain tumor. In the United States, around 30 new ATRT cases are diagnosed each year or three children per 1,000,000.Pediatric brain cancer is the second leading cause of childhood death, just after leukemia.

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Gracie has suffered many setbacks. Although her tumor was removed, it recurred in January, 2016 which caused facial paralysis. She has endured chemotherapy, a stem cell harvest, and three stem cell rescues. She is currently receiving maintenance chemo. During Gracies multiple surgeries and chemotherapies, she has received more than 20 blood transfusions and 20 platelet transfusions. Her family and friends are hopeful for a positive outcome.

Alexwas diagnosed with T-cell Lymphoblastic Lymphoma the day before Thanksgiving, 2016. He is currently being treated at Hackensack Children's Hospital and has been through multiple rounds of heavy chemotherapy with many platelet and red cell transfusions to support his treatment. Alexis in remission, although his treatment will last another two years as T-cell lymphoma is a very aggressive cancer. He is currently 4 years old.

Please Consider Donating Blood

New Jersey Blood Services is urging all healthy persons to donate on Thursday, July 20 from 2:00pm-8:00 pm at the Gracie and Alex Community Blood Drive. Eligible donors should be 17 years of age, or 16 with parental consent. A NYBC Donor Card or signed or photo ID must be presented prior to donating.

Approximately every two seconds, someone needs blood, and one out of three people will need a life-saving blood transfusion in their lifetime. If all eligible blood donors gave at least twice a year, it would greatly help in maintaining and adequate blood supply.

To make an appointment to donate or to run a blood drive in your community, call toll free: 1-800-933-BLOOD (2566).

Visit: http://www.nybloodcenter.org

About Blood Donations

The entire donation process takes less than an hour and a single donation can be used to save multiple lives. Donors with O-negative blood type, or universal donors, are especially encouraged to donate, as their blood can be used in emergencies. Nearly 2,000 donations are needed each day in New York and New Jersey alone. About one in seven hospital admissions requires a blood transfusion, and with a limited shelf life, supplies must be continually replenished.

If you cannot donate but still wish to participate in bringing crucial blood products to patients in need, please ask someone to donate for you, or consider volunteering at a local blood drive.

Any company, community organization, place of worship, or individual may host a blood drive. Blood donors receive free mini-medical exams on site including information about their temperature, blood pressure and hematocrit level. Eligible donors include those people at least age 16 (parental consent is required for 16-year-olds), who weigh a minimum of 110 pounds, are in good health and meet all Food & Drug Administration and NY or NJ State Department of Health donor criteria. People age 76 or older may donate if they have a doctors note on file with New York Blood Center or if they bring one on the day of the blood drive.

About New York Blood Center

Now more than 50 years old, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. NYBCs mission is to serve the 20 million people in the New York/New Jersey metropolitan area and more broadly, our nation and our world by alleviating human suffering and preserving human life using our medical expertise.

Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the worlds largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which among other milestones developed the hepatitis B vaccine and innovative blood purification technology.

Website: nybc.org

Facebook: http://www.facebook.com/newyorkbloodcenter

Twitter: @NYBloodCenter

Instagram: @newyorkbloodcenter

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Blood Drive To Honor 2 1/2-year-old Brain Tumor Patient, 4-year-old Lymphoma Patient - TAPinto.net

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