Stem Cell Clinic

BrainStorm Cell Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Provide a Corporate Update – GlobeNewswire

By Stem Cell Medicine

NEW YORK, Feb. 10, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company will hold a conference call to update shareholders on financial results for the fourth quarter and full year ended December 31, 2019, and provide a corporate update, at 8:00 a.m., Eastern Time, on Tuesday, February 18, 2020.

BrainStorms President & CEO, Chaim Lebovits, will present the full year 2019 corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD, Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.comand questions should be submitted by 5:00 p.m., Eastern Time, Monday, February 17 2020.

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the Investors & Media page of BrainStorms website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

A webcast replay of the conference call will be available for 30 days on the Investors & Media page of BrainStorms website:

About NurOwn

NurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. Brainstorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: 862-397-8160pshah@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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BrainStorm Cell Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Provide a Corporate Update - GlobeNewswire

Protecting growth-restricted babies from brain injury with stem cell therapy – Mirage News

By Stem Cell Treatment

Hudson Institute scientists have demonstrated for the first time that umbilical cord stem cells can protect preterm, growth-restricted babies from brain injury.

Up to five-eight percent of pregnancies in Australia are affected by fetal growth restriction (FGR)-a condition which leads to poor growth of an unborn baby.

The mechanical ventilation that these babies need for the first few days of life can have detrimental effects on the developing brain. Many of them are born early (also referred to as preterm or premature), which only exacerbates the risk of brain injury further.

This brain damage often causes long-term developmental problems, and can lead to conditions such as cerebral palsy, behavioural disorders, cognitive deficits and motor developmental delays.

There is currently no treatment which can be used as an early intervention to prevent brain damage of babies with FGR. However, a growing body of evidence suggests that stem cell therapies could be the answer to this problem.

Dr Atul Malhotra and Associate Professor Suzie Miller led a study published in Stem Cell Research and Therapy which investigated the effect of umbilical cord blood stem cells (UCBCs) in a preclinical model of FGR.

Dr Malhotra is a consultant neonatologist at Monash Newborn, Monash Childrens Hospital; a senior lecturer in the Department of Paediatrics, Monash University; and a research fellow at Hudson Institute. Associate Professor Miller is a Deputy Centre Head at Hudson Institute and a senior scientist at the Department of Obstetrics and Gynaecology, Monash University.

The team demonstrated, for the first time, that UCBCs can alleviate the brain damage caused by FGR and being born preterm-a ground-breaking discovery with significant implications for treatment.

Treatment with UCBCs led to a decrease in neuroinflammation, oxidative stress, cerebrovascular resistance (obstruction to blood flow), and greater integrity of the neurovascular unit in the brain.

The team believe that UCBCs stabilise the neurovascular unit-comprising of several different cell structures that control blood flow to the brain-possibly by reducing the inflammation surrounding them.

These UCBCs therefore act by strengthening the gate keepers of the brain, which in turn mitigates the effects of brain injury caused by an early and growth restricted birth.

We propose that the results of this study lay the foundation for a novel therapeutic option, using cord blood stem cells as an early intervention therapy for these vulnerable babies, commented Dr Malhotra.

Cell therapy is now ready for translation to clinical trials and this study provides further evidence of its potential benefit in preterm infants.

The teams next step is therefore a clinical trial of cord blood therapy in preterm babies at Monash Childrens Hospital, testing feasibility and safety of the treatment.

FGR is a condition where an unborn baby, or fetus, is smaller than expected

It can begin at any time during pregnancy, and puts babies at risk of loss in brain development, which can cause the child long-term problems in later life such as cerebral palsy, autism, learning and other behavioural challenges

Factors in the mother such as high blood pressure, diabetes, cigarette smoking and alcohol or drug use can increase the risk of FGR

The risk can also be increased by the placenta not attaching well, or blood flow through the umbilical cord being limited

Collaborators

Monash University.

Funders

National Health and Medical Research Council (NHMRC), Cerebral Palsy Alliance, The Royal Australasian College of Physicians.

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Protecting growth-restricted babies from brain injury with stem cell therapy - Mirage News

LifeGaines Medical and Aesthetics Provides Innovative Options for Age Management in Their Boca Raton Office – MENAFN.COM

By Stem Cell Treatment

(MENAFN - Newswire) BOCA RATON, Fla.,February 11, 2020(Newswire.com) - Focusing on age management and regenerative therapies, the team at LifeGaines Medical and Aesthetics is led by a highly respected pioneer in age management medicine, Dr. Richard Gaines . Board Certified by the American Board of Anti-Aging & Regenerative Medicine, Dr. Richard Gaines is qualified to provide advanced age managementprotocols to those who seek them. This enables LifeGaines to offer cutting-edge therapies in their Boca Raton office .

As a certified Functional Medicine Practitioner, Dr. Gaines believes in using an integrative approach to achieve total body health. He and his team do this by offering several different treatments to their clients that are said to help people who are aging keep their health throughout their golden years. Among these treatments are hormone replacement therapy, stem cell therapy and joint injections. Get age management treatments from a trusted Boca Ratonphysician at LifeGaines Medical and Aesthetics.

Age management looks different for every person that visits LifeGaines Medical and Aesthetics . Some people are looking for help in maintaining their sexual wellness while others are more concerned with cosmetic changes like sunspots and unsightly veins. The team at LifeGaines understands that overall well-being is about both controlling the physiological changes as well as the cosmetic changes. To best serve their clients, LifeGaines Medical and Aesthetics also offers aesthetic procedures in their age management programs. The most common of these procedures are PRP facials, sun spot removal, Botox, and spider vein removal. Access advanced age management practices by calling LifeGaines Medical and Aesthetics at (561) 931-2430.

In addition to their wellness therapies and cosmetic procedures, Dr. Richard Gaines also helps those suffering from sexual dysfunction due to aging. Without the use of commonly prescribed pharmaceuticals, Dr. Gaines and the team at LifeGaines use hormone therapy to help their clients maintain their sexual wellness and boost their libido. As a piece of overall health, sexual wellness is a significant part of age management medicine.

LifeGaines Medical and Aesthetics is an age management practice owned by renowned functional medicine practitioner, Dr. Richard Gaines. His age management practice provides a wide selection ofcosmetic treatments from their office located atFlorida. The team at LifeGaines specializes in age management treatments, stem cell therapy, sexual wellness and platelet-rich plasma procedures. With the services offered at LifeGaines Medical and Aesthetics, South Floridians can maintain their overall health and improve their quality of life as they age. Aging Floridiansshould visit LifeGaines Medical and Aesthetics online or call their office at 3785 N. Federal Highway in BocaRaton to schedule their initial consultation.

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LifeGaines Medical and Aesthetics Provides Innovative Options for Age Management in Their Boca Raton Office - MENAFN.COM

Inflammasome Pathway Linked to MS and Diseases of Aging Has an… – Multiple Sclerosis News Today

By Stem Cell Treatment

Immune cells have an inflammation switch that involves the NLRP3 inflammasome pathway, and targeting it may prevent or even reverse the chronic inflammation seen in diseases like multiple sclerosis (MS) and in conditions associated with aging, an early study suggests.

The inflammation marking MS has been linked to NLRP3 inflammasome activation.

The study, An Acetylation Switch of the NLRP3 Inflammasome Regulates Aging-Associated Chronic Inflammation and Insulin Resistance, was published in the journal Cell Metabolism.

Chronic inflammation, which results from an overactive immune response, can intensify with age and lead to a variety of illnesses, fromAlzheimersand MS to cancer and diabetes.

The molecular triggers responsible for provoking the immune system, however, are not clear.

A team led by researchers at the University of California (UC), Berkeley, discovered a molecular switch that controls chronic inflammation in the body.

Using models of older mice, the scientists developed a cell-based system that models aging-associated inflammation. It simulates the effects of inflammation over metabolism including for insulin resistance, a pre-diabetic condition marked by cells that no longer respond well to insulin.

My lab is very interested in understanding the reversibility of aging, Danica Chen, professor at UC Berkeley, and the studys senior author, said in a news story.

In the past, we showed that aged stem cells [progenitor cells with the potential to develop into several cell types] can be rejuvenated. Now, we are asking: to what extent can aging be reversed?

And we are doing that by looking at physiological conditions, like inflammation and insulin resistance, that have been associated with aging-related degeneration and diseases, Chen added.

Using their models, the team showed that a pathway wired to immune cells, called theNLRP3 inflammasome, is at the origin of aging-associated inflammation. Importantly, the researchers found a potential way to switch it off.

This inflammasome consists of a sensor molecule, called NLRP3, that senses threats or danger signals inside immune cells, to rapidly recruit other proteins and launch an inflammatory response. Such a pathway is central to coordinating proinflammatory responses, and has been implicated in chronic conditions like MS, cancer, and diabetes.

Research in MS patients suggests that inflammasome activation occurs during disease. Experiments in MS mouse models also support the NLRP3 inflammasome as critical and necessary to MS development.

Working with mice and immune cells called macrophages, Chen and his colleagues discovered that a specific chemical modification called acetylation (the addition of an acetyl group to a compound) works as a molecular switch that turns on this inflammasome.

When NLRP3 is acetylated, it stays in a more active form that favors inflammation, they reported. However, this active state can be prevented by a protein called SIRT2 that takes out the acetyl (essentially, deacetylates NLRP3), shutting off the inflammasome.

Mice genetically engineered to lack SIRT2 showed more signs of inflammation at an older age than did their normal counterparts. These mice also exhibited higher insulin resistance, a condition associated with type 2 diabetes and metabolic syndrome.

This acetylation can serve as a switch, Chen said. So, when it is acetylated, this inflammasome is on. When it is deacetylated, the inflammasome is off.

This finding suggests that treatments that deacetylate switch off the NLRP3 inflammasome might help to prevent or treat conditions related to aging and inflammation, and perhaps age-related degeneration in general.

Studying older mice that produced either the deacetylated or the acetylated version of NLRP3, the team saw that those with the deacetylated, or off, version of the inflammasome had better insulin resistance after six weeks.

This suggests that targeting NLRP3 acetylation might actually reverse inflammatory conditions.

These results establish the dysregulation of the acetylation switch of the NLRP3 inflammasome as an origin of aging-associated chronic inflammation, and highlight the reversibility of aging-associated chronic inflammation and insulin resistance, researchers wrote.

I think this finding has very important implications in treating major human chronic diseases, Chen said.I think its more urgent than ever to understand the reversibility of aging-related conditions, and use that knowledge to aid a drug development for aging-related diseases.

Ana is a molecular biologist with a passion for discovery and communication. As a science writer, she looks for connecting the public, in particular patients and healthcare providers, with clear and quality information about the latest medical advances. Ana holds a Ph.D. in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in infectious diseases, epigenetics, and gene expression.

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Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Inflammasome Pathway Linked to MS and Diseases of Aging Has an... - Multiple Sclerosis News Today

Astrocytes could be harnessed to protect motor neurons in MND – Drug Target Review

By Adult Stem Cells

Scientists using a new motor neuron disease (MND) model have shown astrocytes may protect neurons from toxic TDP-43 protein aggregates in the early stages of disease.

Researchers have discovered that astrocytes can protect motor neurons in the central nervous system (CNS) from the toxicity of misfolded protein, TDP-43, in sporadic motor neuron disease (MND). The team suggest this rescue mechanism could be harnessed to slow disease progression, particularly in amyotrophic lateral sclerosis (ALS).

The study, published in Brain, demonstrated that this neurodegenerative disease is caused by accumulation of TDP-43 in motor neurons, resulting in cell death. However, the scientists noted that TDP-43 accumulation in neural support cells, called astrocytes, does not cause death. Instead they appear comparatively resistant.

According to the paper, when the two cell types are together, astrocytes protect motor neurons from the protein aggregates, promoting their survival. The researchers from the Francis Crick Institute and University College London, both UK, suggest that these cells may therefore be supporting motor neurons early on in sporadic MND. They called this a rescue mechanism.

when the two cell types are together, astrocytes protect motor neurons from the protein aggregates, promoting their survival

The role astrocytes have played in dealing with toxic forms of TDP-43 in motor neurons has not been previously well documented in motor neuron disease. Its exciting that weve now found that they may play an important protective role in the early-stages of this disease, explains Phillip Smethurst, lead author and former postdoc in the Human Stem Cells and Neurodegeneration Laboratory at the Crick. This has huge therapeutic potential finding ways to harness the protective properties of astrocytes could pave the way to new treatments. This could prolong their rescue function or find a way to mimic their behaviour in motor neurons so that they can protect themselves from the toxic protein.

In order to conduct this research, the team created a new model for MND, which more closely resembles the disease in patients. In the model they took healthy adult stem cells and exposed them to the toxic TPD-43 protein using post-mortem spinal cord tissue samples donated by patients with MND.

For the first time, we have been able to create a model of sporadic motor neuron disease by essentially transferring the toxic TDP-43 protein from post-mortem tissue into healthy human stem cell-derived motor neurons and astrocytes in order to understand how each cell type responds to this insult, both in isolation and when mixed together, said Dr Rickie Patani, co-senior author, group leader of the Human Stem Cells and Neurodegeneration Laboratory at the Crick and Professor of Human Stem Cells and Regenerative Neurology at UCL Queen Square Institute of Neurology.

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Astrocytes could be harnessed to protect motor neurons in MND - Drug Target Review

BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn Regulatory Pathway for Approval in ALS – Yahoo Finance

By Adult Stem Cells

NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).

In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.

Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible.

This is a key turning point in ourworktowardprovidingALSpatientswith a potential new therapy,said ChaimLebovits, President and CEO ofBrainStorm. We commend the FDA foritscommitmentto the ALS communityandtofacilitating the development, and we ultimately hope, the approvalofNurOwn.The entire BrainStorm team is grateful for the ongoing and conscientious collaboration in the quest to beat ALS.

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, stated, The entire team at BrainStorm has collectively worked to ensure that we conduct the finest, science-based clinical trials. We had the opportunity to communicate with Senior Leadership at the FDA and discuss how we can work together to navigate the approval process forward along a novel pathway. We appreciate their willingness and receptiveness to consider innovative approaches as we all seek to better serve the urgent unmet medical needs of the ALS community.

Brian Wallach, Co-Founder of I AM ALS stated: There is nothing more important to those living with ALS than having access to therapies that effectively combat this fatal disease. We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. We were privileged to represent the patient voice at this meeting and are truly grateful to the company and the FDA for this critical agreement. This is a truly important moment of hope and we look forward to seeing both the Phase III data and the hopeful approval of NurOwn as soon as is possible.

About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

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Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

Or

Katie Gallagher | Account Director, PR and MarketingLaVoieHealthScience Strategic CommunicationsO: 617-374-8800 x109M: 617-792-3937kgallagher@lavoiehealthscience.com

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BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn Regulatory Pathway for Approval in ALS - Yahoo Finance

Mexico City Medical Congress to Showcase the Global Stem Cells Group’s Latest Innovations – PRUnderground

By Adult Stem Cells

The Global Stem Cells Group (GSCG) is set to sponsor the XI Congreso Mundial de Medicina Antienvejecimiento y Longevidad (World Conference of Anti-Aging and Longevity Medicine) to be held in Mexico City, Mexico on February 16-18, 2020.

The medical congress is expected to attract over 450 physicians and researchers from across the world interested in anti-aging and longevity practices and medical innovations. Over 30 speakers are slated to share information with attendees on a wide range of topics on how to lead a long, healthy life and improve longevity.

The GSCG is set to share a number of its latest innovations with congress attendees, including its newly released GCell technology device. This cutting-edge tool utilizes micrograft technology to harness the natural and powerful restorative capabilities of adipose tissues. Because it is FDA compliant, the device allows physicians across the globe to continue practicing adult stem cells-based procedures.

Additional benefits of GCell technology include shorter treatment times, delivering in-office treatments in around 30 minutes with local anesthesia, as well as less fat collection compared to existing treatments (15 mL versus 50 mL). GCell technology holds exciting implications across a range of medical specialties, including orthopedics, dermatology, cosmetic gynecology, aesthetics, and hair loss.

In addition to its GCell technology, the GSCG will also feature its newest line of stem cells products derived from first-tissue exosomes. Cellgenic Flow Exosomes utilizes the latest science and research available in cellular therapies to deliver a non-surgical approach to creating regenerative responses in a broad range of treatments. The product utilizes exosomes, which replicate the signals given out by stem cells, versus actual stem cells. Exosomes play a pivotal role in cell-to-cell communication and are involved in a wide range of physiological processes. These particles transfer critical bioactive molecules such as proteins, mRNA, and miRNA between cells and regulate gene expression in recipient cells.

The XI Congreso Mundial de Medicina Antienvejecimiento y Longevidad is one of the worlds premier events connecting physicians and researchers with todays most innovative treatments and technologies utilizing regenerative medicine, said Benito Novas, CEO of the GSCG. As a worldwide leader in training, education, and innovative products in the field of regenerative medicine, the GSCG is pleased to sponsor this congress and share its exciting new portfolio of products with physicians from across the world.

To learn more about the Global Stem Cells Group and all of the groups latest news and innovations, visit http://www.stemcellsgroup.com/

About Global Stem Cells Group

Global Stem Cells Group (GSCG) is a worldwide network that combines seven major medical corporations, each focused on furthering scientific and technological advancements to lead cutting-edge stem cell development, treatments, and training. The united efforts of GSCGs affiliate companies provide medical practitioners with a one-stop hub for stem cell solutions that adhere to the highest medical standards.

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Mexico City Medical Congress to Showcase the Global Stem Cells Group's Latest Innovations - PRUnderground

Bone Therapeutics to present preclinical data on the osteogenic properties of ALLOB in bone repair at the Annual Meeting of the Orthopaedic Research…

By Adult Stem Cells

Press Release

Gosselies, Belgium, 11February 2020, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapies to address high unmet medical needs in orthopaedics and bone diseases, announces that the Company will today present at the Annual Meeting of the Orthopaedic Research Society (ORS), in Phoenix (Arizona), USA.

The Annual ORS Meeting is the yearly summit organised by the international Orthopaedic Research Society, gathering scientists, clinicians and entrepreneurs to advance musculoskeletal research and orthopaedic care. In the oral presentation, Bone Therapeutics will highlight additional preclinical in vitro and in vivo results demonstrating the potent osteogenic properties of its allogeneic bone-forming cell therapy platform, ALLOB, to promote bone-formation and improve fracture healing in relevant models.

ALLOB is the Companys allogeneic product that consists of human bone-forming cells derived from cultured bone marrow mesenchymal stem cells of healthy adult donors, and is manufactured through a proprietary, scalable production process. ALLOB successfully completed two Phase II studies in two indications and the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the PhaseIIb clinical trial in patients with difficult-to-heal tibial fractures.

Presentation Details:

Title: ALLOB, A Ready-to-use and Injectable Cryopreserved Allogenic Cell Therapy Product Derived from Bone Marrow Mesenchymal Stem Cells, Displays Potent Osteoinductive and Osteogenic Properties, Leading to Enhanced Bone Fracture HealingSpeaker: Sandra Pietri, PhD Associate Director R&D, Bone TherapeuticsSession: Podium Session 58 Bone Cell Signaling and TreatmentsDate: Tuesday, 11 February 2020Time: 8:00am 9:00am MST (4pm 5 pm CET)Location: Room West 301D, Phoenix Convention Center, Phoenix, Arizona, USA

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering Phase III development for the treatment of pain in knee osteoarthritis. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) to start the pivotal Phase III program has been submitted to the regulatory authorities in Europe and the trial is expected to start in Q1 2020.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the promising Phase IIa efficacy and safety results for ALLOB, the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the Phase IIb clinical trial with ALLOB in patients with difficult-to-heal fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

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Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Consilium Strategic CommunicationsMarieke VermeerschTel: +44 (0) 20 3709 5701bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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They Are Happier. They Are In Less Pain: Butler Co. Vet Uses Stem Cell Therapy To Help Heal Dogs – CBS Pittsburgh

By Stem Cell Treatment

PITTSBURGH (KDKA) Dr. Mike Hutchinson, DVM performed his first stem cell procedure in 2008. Nearly 12 years later, he can tell you all about his first case.

It was a lab mix. It couldnt get up on this floor. We tried to help it up, and it was having trouble walking so we treated it, says Hutchinson.

Fourteen days later, it came for suture removal, and it was already walking in here. He even put his front feet on the table.

Based on early success stories like that, KDKA-TV featured a 10-year-old German Shepherd named Angel.

When we met her, Angel limped noticeably from arthritis in her hips. After stem cell treatment, the dogs owner Jane Fornear says her beloved pet looked like a new dog.

Within 48 hours, her eyes were clear, explained Fornear.

She had Angel show us how much better she felt: she asked the big shepherd to sit in front of her, then told Angel, Give me your paw.

WATCH: Angels Journey To Recovery

Angel immediately lifted her right paw and put in in Fornears waiting hand about 3 feet off the ground.

Jane released the paw and said, Give me your other paw. Just as quickly, Angel lifted her left front paw off the ground and put it in Fornears other hand.

You could almost hear the tears building in Fornears voice as she petted her dogs face and ears. We couldnt give our paw before because our arms and legs hurt too much, didnt they?

Fast forward to 2014. Panzer is a large breed mix who tore the anterior cruciate ligament in one of his legs.

Dr. Mike told Panzers owner the dog would be a great candidate to use injected stem cells to help speed healing in the joint.

Sharon Germain remembers that conversation like it just happened: I just sat there going really? And I said anything to make things heal better and make him feel better. I was on board immediately.

Seven months after having the ACL repair surgery with stem cells, KDKA was there with Sharon watching Panzer tear through the November snow in Germains backyard like a hyperactive puppy.

Seeing is believing. Its just Germain paused and then let out a big sigh. It just does your heart good to see this. Germain was fully convinced it had worked for her dog.

Since those early surgeries, Hutchinson has never stopped talking about using stem cells to treat animals that are in pain.

In 2015, he told KDKA, Its just rewarding to hear from grateful pet owners over and over and over, said the Ohio State Vet School graduate. Its why I do it.

Panzer lived four years after his initial stem cell treatment. Germain said he never slowed down because his pain was gone.

It was like nothing ever happened to him. It was like he never even had surgery, says Germain. I mean, outside of a little white hair where the surgery incision was made, that was it.

Many other animals have had similar results. Hutchinson has now given stem cells to more than 1,100 animals. Many of the pets are dogs, but he has also worked with race horses as well as racing camels in the Middle East.

WATCH: Panzers Experience With Stem Cells

He has lectured and scrubbed in on stem cell surgeries around the world, Canada, South America, Australia, and across the United States.

Yet the majority of the surgeries are done at his Animal General veterinary practice in Cranberry, Butler County everyday pets like Baxter who had not one, but two torn ACLs.

They were both completely severed, explained Baxters owner Nicole Mountain of OHara Township.

He had no mobility. He had no use of his back legs. My husband Jeff was carrying him outside to use the bathroom.

Baxter is a not a little dog. He is a 95 pound Staffordshire-terrier mix. He tore those knee ligaments in 2014.

Another orthopedic vet repaired the injured joints with a procedure called PTLO surgery. It involved putting metal plates in his back legs. The Mountains were warned that it would be a long and painful recovery for their dog and for them.

(Photo Credit: KDKA)

Mountain agrees saying it was every bit as bad as they warned and then some.

Baxter was moaning in pain, Mountain says. He was pumped up with so much pain medication he was vomiting. He couldnt hold food down. He couldnt move.

Eighteen months later, Baxter was mostly healed from the surgeries, but he was still in significant pain. That is when the Mountains learned of Dr. Hutchinsons use of stem cells.

Nicole was ready to go from the moment she heard about the procedure. Her husband Jeff wasnt exactly sold.

Ill be honest, when Nicole sent us out there, I thought it was crazy. You know, I honestly did, said Jeff Mountain. I said youre sending us to this Voodoo doctor to do this stem cell treatment. I said, Where is it going to stop?'

Mountain had lived through the ordeal of helping Baxter heal from his ligament problems.

My husband was calling from Samsonite because we had one of those Help-Me harnesses, and he was lifting him up and carrying him out like luggage.

When they heard about how other dogs had been helped by stem cells, they decided to give it a try. Dr. Hutchinson recalls the conversation with the Mountains at their initial consultation.

They wanted to know if the stem cells would help the arthritis, and I said thats exactly what I would treat it with. That would be my gold therapy for that so we did that, and that had a very positive response as well. Then we were able to bank some of those cells for the future, recalls Hutchinson.

It didnt take long for the Mountains to see that Baxter was visibly better.

Within about a month, we started to really see him jumping up on counters for treats, said Jeff Mountain. You know, when we went out to walk him, he is back to running.

Mountain said that wasnt the only change she noticed.

He had this almost it sounds almost funny to say he looked very white, she paused to think. It was almost like his eyes were brighter. He was just a brighter dog. He just looked like, there was a visible difference in him.

Dr. Mike has heard it all many times.

People say it looks like their dogs are younger because their eyes are brighter. They are happier. They are in less pain, and thats a great reward for stem cells, explains Dr. Mike.

One of prospective patients first questions is often how much will it cost? When Hutchinson started, each procedure ran about $3,200. Now it has come down to about $1,800.

It can be less than that. The Mountains have a pet insurance on Baxter, and the stem cell therapy was covered by their policy.

I thought it was cost effective too, reflected Jeff Mountain, compared to other things that weve spent money on for surgeries and treatments for the dogs.

Lets go back to Panzer, Sharon Germains beloved dog. He lived nearly four years after surgery, before dying about a year ago. In retrospect knowing what she knows now, would she spend the out-of-pocket money to do stem cell treatment again on her dog?

Absolutely. Absolutely. The best money spent. Without hesitation, says Germain.

The next question: would you do it again for another dog?

Germain didnt even flinch. Absolutely. I would do it again for me.

She knows all about that too. After seeing how well it worked for her dog, she had stem cells injected into her chronically painful knee. Like her dog, she says her pain was gone in a matter of days, and it hasnt come back.

Dr. Hutchinson stresses stem cells are not a cure-all. They cant be used for every ailment, and Hutchinson says that in every lecture he does on stem cells.

I think its incumbent upon all my colleagues to be ethical and pick the right cases, says Hutchinson.

Its not a panacea. Its for certain cases. Neurological dogs, dogs that are falling over, they have nerve damage. Yeah, there might be a stem cell compassionate use for that and that might be able to help that dog, but Im not going to pretend like thats the common case.

How long do they last?

On average, it doesnt last a lifetime and it lasts maybe a year, a year and a half.

Hutchinson stopped for a second, then continued, But thats huge in a dogs life. They have a short life expectancy. So, if we get a year to year-and-a-half of comfort and pain-free time, thats fantastic. Then we can come back and re-treat them, and expect the similar response when we re-treat them.

Baxters mom Nicole Mountain agrees wholeheartedly that his quality of life is much better than it was before stem cells.

He does not get pain medication. He does not get anti-inflammatories, she claims.

He doesnt take anything thats keeping him comfortable. So for us to have something natural that will last ten, eleven months and then we do again, were thrilled with that.

Dr. Mike harvested enough cells from the original procedure on Baxter that they froze enough for multiple follow-up treatments. Because of that foresight, all they have to do is inject the thawed stem cells into Baxter. Those tune-ups cost about $200 per treatment.

Hutchinson cant say enough about what he has learned since his first stem cell surgery in 2008.

I want to do this every day in my practice because Ive been a vet for a long time, 30 plus years, and when you see the kind of results that were seeing, you know it cant be denied that any veterinarian would want to do what Im doing.

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They Are Happier. They Are In Less Pain: Butler Co. Vet Uses Stem Cell Therapy To Help Heal Dogs - CBS Pittsburgh

Arthritis Treatment: One Royal Is Promoting A Certain Kind Of Treatment – International Business Times

By Stem Cell Treatment

KEY POINTS

Arthritis is one of the most painful diseases around. Patients would often be taking pain relievers just to combat pain. There are those who seek doctors and are given over-the-counter medications, and there are also those who go the natural means. One royal is promoting a certain kind of treatment, and while the said treatment may have been dubbed as a controversial one, health experts say that it might just help.

The Use of Stem Cells

Stem cell treatment may be the next big thing when it comes to treating arthritis. As per Express report, a lot of doctors have already started using stem cell therapy to treat the debilitating disease. Although it is not considered as a standard practice, with many calling the treatment as controversial, it would seem that more people are going this way. stem cell treatment arthritis Photo: darkostojanovic - Pixabay

This type of treatment reduces inflammation in the body. When inflammation is kept at bay, pain is likewise reduced, allowing patients to suffer less from the disease. This kind of therapy helps in increasing the number of healthy cells.

The Royal Princess

According to the report of Express, Princess Michael of Kent, the wife of Prince Michael, who is the Queens cousin, recently appeared in an ad. In the said promotional video, the Princess was showing her right arm, signifying that stem cells are the future.

She had stem cell injections for the painful shoulder. The video was for a clinic in the Bahamas that offers the arthritis stem cell treatment.

Stem Cell and Arthritis

Researchers are still looking for ways on how to use stem cells to regenerate tissues and to control inflammation. The mesenchymal stem cells (MSCs) are the types of stem cells that develop into cartilage and bone. This has shown great promise in treating arthritis.

Despite the positive responses that the treatment has, there are still those who doubt it and would consider it as controversial. As for those who have benefited from the treatment, maybe stem cells did wonders for them. It could be an avenue for those who are still looking for effective arthritis treatment.

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Arthritis Treatment: One Royal Is Promoting A Certain Kind Of Treatment - International Business Times

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