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Novartis eyes up another gene therapy – Vantage

Posted: December 24, 2021 at 2:24 am

Apelliss intravitreal formulation of pegcetacoplan targeted C3, and produced a hit and a miss in its twin phase 3 studies, leaving that projects approval prospects in doubt.

Gyroscope recently reported interim data from the phase 1/2 Focus study of GT005, which is delivered via subretinal injection and uses an AAV2 vector. The trial found no serious adverse events among 28 patients, but there was one case of choroidal neovascularisation, which was possibly related to GT005. Apelliss pegcetacoplan was also linked with neovascularisations in phase 2, although this was not so much of an issue in phase 3.

Focus also showed biomarkers going in the desired direction: 11 of 13 evaluable patients had increased complement factor I; all of these 11 had decreases in certain proteins associated with complement activation.

It will now be up to Novartis to prove that this translates into a benefit on geographic atrophy progression. Two phase 2 trials, Explore and Horizon, are ongoing.

Doubling down

Novartis was not the only big pharma to see potential in Gyroscope: Sanofi, another serial acquirer, made a $40m investment in the UK group last month. Other major players are also getting involved in geographic atrophy, with Roche this week striking a small licensing deal with Lineage Cell Therapies.

In many ways, the Gyroscope deal makes sense for Novartis: the group already has a presence in gene therapy and has made no secret of its intention to expand here. In the past year or so it has also picked up the early-stage ocular gene therapy players Vedere Bio and Arctos Medical.

And, with gene therapy price tags depressed, now is probably a good time to buy. But big questions still hang over the field in general, notably around safety, durability and commercial viability.

Even Zolgensma, a relative success story, has not been without its problems, and with US sales flattening the jury is still out on whether the product will justify the $8.7bn that Novartis paid for its developer, Avexis.

In a few years it should become apparent whether Novartiss decision to stick to its gene therapy guns was laudable or just another example of the sunk-cost fallacy.

The undisputed winner from todays takeout is Syncona, Gyroscopes founding investor, which also had a successful exit with Biogens 2019 takeout of another eye gene therapy player, Nightstar. That deal turned out to be a dud, however, and Novartis will have to hope that Gyroscope does better.

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Avra, Inc. Completes its Merger with Springs Rejuvenation, LLC, a Stem Cell and Anti-Aging Treatment Company – GlobeNewswire

Posted: December 24, 2021 at 2:23 am

ATLANTA, GA, Dec. 20, 2021 (GLOBE NEWSWIRE) -- viaNewMediaWire --Avra, Inc. (OTC PINK: AVRN), is pleased to announce that it has closed the merger with Springs Rejuvenation, LLC (https://springsrejuvenation.com). The surviving entity will be Springs Rejuvenation, Inc. (SPRINGS), a Chamblee, Georgia anti-aging and stem cell center focusing on stem cell therapy, facial rejuvenation, hair rejuvenation, non-surgical hair restoration, protein rich plasma (PRP) injections, and anti-aging treatments.

The merger documents have been filed with the State of Nevada. They have also been posted on OTC Markets along with the Consolidated financials in the last quarterly filing. On December 20, 2021, Avra, Inc. filed a Corporate Action with FINRA for a name and ticker change.

SPRINGS was founded and incorporated in the State of Georgia in May of 2019 by Dr. Charles Pereyra. The company currently has one facility located in Chamblee, Georgia. Dr. Pereyra, has assembled a very skilled team of doctors and support staff to expand the business. They include Dr. Juan P. Nieto M.D., Dr. Andrew Bernstein M.D., and Alyssa Stilwell, as executive director.

Dr. Pereyra is a practicing physician with multiple peer-reviewed publications. He earned an undergraduate degree from Cornell University, where his work with stem cells began, a Doctorate of Medicine (M.D.) from St. Georges University, and completed his residency training at New York Presbyterian Hospital Brooklyn.

Stem cell therapy is a form of regenerative medicine, designed to repair damaged cells within the body by reducing inflammation and modulating the immune system. This makes stem cell therapy a viable treatment option for a variety of medical conditions. Stem cell therapies are currently being researched throughout the country with many positive results. Showing profound outcomes in autoimmune, inflammatory, neurological, and orthopedic conditions; including Multiple Sclerosis, Lupus, Crohns disease, COPD, Parkinson's, ALS, Stroke, Congestive Heart Failure and more. Recently the FDA has begun to grant INDs for use of products containing stem cells for several conditions.

A primary goal of the merger is to allow SPRINGS to duplicate its model of high-quality stem cell treatments throughout the United States. SPRINGS is in the process of opening a facility in Austin, Texas, in conjunction with an existing clinic, and a third location in southeast Florida. The Company plans to open a total of ten new facilities in the next twelve months.

I am excited for SPRINGS Rejuvenation to take the next step with the Avra merger. Ive always been passionate about delivering the highest quality care to my patients and making sure they have the most cutting-edge medical treatments available. For over a decade a community of only a select few has benefited from use of stem cells. With this merger we will not only expand our reach to many communities, but also drive down the cost of stem cells for everyone, making access to these remarkable treatments much easier. Im incredibly excited for the future, said Dr. Charles Pereyra.

http://www.avrabiz.com

avrabiz21@gmail.com

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Regenerative medicine could help avoid the death knell – Northeast Mississippi Daily Journal

Posted: December 24, 2021 at 2:19 am

Country

United States of AmericaUS Virgin IslandsUnited States Minor Outlying IslandsCanadaMexico, United Mexican StatesBahamas, Commonwealth of theCuba, Republic ofDominican RepublicHaiti, Republic ofJamaicaAfghanistanAlbania, People's Socialist Republic ofAlgeria, People's Democratic Republic ofAmerican SamoaAndorra, Principality ofAngola, Republic ofAnguillaAntarctica (the territory South of 60 deg S)Antigua and BarbudaArgentina, Argentine RepublicArmeniaArubaAustralia, Commonwealth ofAustria, Republic ofAzerbaijan, Republic ofBahrain, Kingdom ofBangladesh, People's Republic ofBarbadosBelarusBelgium, Kingdom ofBelizeBenin, People's Republic ofBermudaBhutan, Kingdom ofBolivia, Republic ofBosnia and HerzegovinaBotswana, Republic ofBouvet Island (Bouvetoya)Brazil, Federative Republic ofBritish Indian Ocean Territory (Chagos Archipelago)British Virgin IslandsBrunei DarussalamBulgaria, People's Republic ofBurkina FasoBurundi, Republic ofCambodia, Kingdom ofCameroon, United Republic ofCape Verde, Republic ofCayman IslandsCentral African RepublicChad, Republic ofChile, Republic ofChina, People's Republic ofChristmas IslandCocos (Keeling) IslandsColombia, Republic ofComoros, Union of theCongo, Democratic Republic ofCongo, People's Republic ofCook IslandsCosta Rica, Republic ofCote D'Ivoire, Ivory Coast, Republic of theCyprus, Republic ofCzech RepublicDenmark, Kingdom ofDjibouti, Republic ofDominica, Commonwealth ofEcuador, Republic ofEgypt, Arab Republic ofEl Salvador, Republic ofEquatorial Guinea, Republic ofEritreaEstoniaEthiopiaFaeroe IslandsFalkland Islands (Malvinas)Fiji, Republic of the Fiji IslandsFinland, Republic ofFrance, French RepublicFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabon, Gabonese RepublicGambia, Republic of theGeorgiaGermanyGhana, Republic ofGibraltarGreece, Hellenic RepublicGreenlandGrenadaGuadaloupeGuamGuatemala, Republic ofGuinea, RevolutionaryPeople's Rep'c ofGuinea-Bissau, Republic ofGuyana, Republic ofHeard and McDonald IslandsHoly See (Vatican City State)Honduras, Republic ofHong Kong, Special Administrative Region of ChinaHrvatska (Croatia)Hungary, Hungarian People's RepublicIceland, Republic ofIndia, Republic ofIndonesia, Republic ofIran, Islamic Republic ofIraq, Republic ofIrelandIsrael, State ofItaly, Italian RepublicJapanJordan, Hashemite Kingdom ofKazakhstan, Republic ofKenya, Republic ofKiribati, Republic ofKorea, Democratic People's Republic ofKorea, Republic ofKuwait, State ofKyrgyz RepublicLao People's Democratic RepublicLatviaLebanon, Lebanese RepublicLesotho, Kingdom ofLiberia, Republic ofLibyan Arab JamahiriyaLiechtenstein, Principality ofLithuaniaLuxembourg, Grand Duchy ofMacao, Special Administrative Region of ChinaMacedonia, the former Yugoslav Republic ofMadagascar, Republic ofMalawi, Republic ofMalaysiaMaldives, Republic ofMali, Republic ofMalta, Republic ofMarshall IslandsMartiniqueMauritania, Islamic Republic ofMauritiusMayotteMicronesia, Federated States ofMoldova, Republic ofMonaco, Principality ofMongolia, Mongolian People's RepublicMontserratMorocco, Kingdom ofMozambique, People's Republic ofMyanmarNamibiaNauru, Republic ofNepal, Kingdom ofNetherlands AntillesNetherlands, Kingdom of theNew CaledoniaNew ZealandNicaragua, Republic ofNiger, Republic of theNigeria, Federal Republic ofNiue, Republic ofNorfolk IslandNorthern Mariana IslandsNorway, Kingdom ofOman, Sultanate ofPakistan, Islamic Republic ofPalauPalestinian Territory, OccupiedPanama, Republic ofPapua New GuineaParaguay, Republic ofPeru, Republic ofPhilippines, Republic of thePitcairn IslandPoland, Polish People's RepublicPortugal, Portuguese RepublicPuerto RicoQatar, State ofReunionRomania, Socialist Republic ofRussian FederationRwanda, Rwandese RepublicSamoa, Independent State ofSan Marino, Republic ofSao Tome and Principe, Democratic Republic ofSaudi Arabia, Kingdom ofSenegal, Republic ofSerbia and MontenegroSeychelles, Republic ofSierra Leone, Republic ofSingapore, Republic ofSlovakia (Slovak Republic)SloveniaSolomon IslandsSomalia, Somali RepublicSouth Africa, Republic ofSouth Georgia and the South Sandwich IslandsSpain, Spanish StateSri Lanka, Democratic Socialist Republic ofSt. HelenaSt. Kitts and NevisSt. LuciaSt. Pierre and MiquelonSt. Vincent and the GrenadinesSudan, Democratic Republic of theSuriname, Republic ofSvalbard & Jan Mayen IslandsSwaziland, Kingdom ofSweden, Kingdom ofSwitzerland, Swiss ConfederationSyrian Arab RepublicTaiwan, Province of ChinaTajikistanTanzania, United Republic ofThailand, Kingdom ofTimor-Leste, Democratic Republic ofTogo, Togolese RepublicTokelau (Tokelau Islands)Tonga, Kingdom ofTrinidad and Tobago, Republic ofTunisia, Republic ofTurkey, Republic ofTurkmenistanTurks and Caicos IslandsTuvaluUganda, Republic ofUkraineUnited Arab EmiratesUnited Kingdom of Great Britain & N. IrelandUruguay, Eastern Republic ofUzbekistanVanuatuVenezuela, Bolivarian Republic ofViet Nam, Socialist Republic ofWallis and Futuna IslandsWestern SaharaYemenZambia, Republic ofZimbabwe

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New Insights Into How the Brain Functions – Technology Networks

Posted: December 24, 2021 at 2:19 am

To better appreciate how a complex organ such as the brain functions, scientists strive to accurately understand both its detailed cellular architecture and the intercellular communications taking place within it.

At Baylor College of Medicine, Dr. Md. Abul Hassan Samee and his colleagues have taken a major step in that direction. They developed advanced computational methods that led to new insights into the intricacies of brain structure and function that may enhance the understanding of this complex organ, both in health and disease.

Currently, we have technologies that allow us to identify and locate individual cells in a tissue. We are also capable of determining what are the products produced by each single cell in that tissue, said corresponding author Samee, assistant professor of molecular physiology and biophysics and a member of the Center for Organ Repair and Renewal at Baylor.

Mammalian brains are complex and comprise several millions to hundreds of billions of cells, and, when analyzed, they generate vast amounts of data. The challenge has been to develop ways to integrate the information in those datasets to generate a model that reliably reflects how an organ works.

In the current study, Samee collaborated with Francisco Jos Grisanti Canozo, first author of the work, and Dr. James Martin, both with Baylor and the Texas Heart Institute, and Zhen Zuo, also with Baylor, to develop a neural network model to elucidate architectural and functional aspects of complex tissues. They have called the model Spatial Transcriptomics cell-types Assignment using Neural Networks (STANN).

We also used other advanced, sophisticated computational methodologies that make the model more rigorous, Samee said. We applied STANN and the other methods to existing brain datasets of the mouse olfactory bulb and started to see very interesting patterns in the brains cellular architecture and functionality.

The brain comprises distinct morphological layers, and STANN allowed the researchers to predict a detailed picture of their cellular organization. Layer by layer, our model provided the precise location of different cell types, whether they communicated with each other and by which means, Samee said. This was a eureka moment for us.

Samee and his colleagues determined that the cell-type composition is quite consistent within a morphological layer. For example, a particular layer may have a certain percentage of astrocytes, neurons and microglia that remains the same throughout the same layer. If we take several small sections from different areas of the same morphological layer, these percentages look very similar to each other. However, the percentages may change from one layer to another, Samee explained.

The team saw a different pattern emerge when they looked at cell colocalization. For instance, in one area of a morphological layer we may see astrocytes colocalize with olfactory neurons. But in another area from the same morphological layer these cells can be completely separated, Samee explained. We also see that intercellular communication between two cell types changes in different areas of a morphological layer, a reflection that gene regulatory networks are changing with location.

The researchers hypothesize that morphological layers in the brain have different spatially localized communities of cell types. The communities are similar in cell type composition, but there are large differences in how cell types colocalize and communicate within a community. This suggests that brain cell types have spatially localized subtypes performing location-specific functions.

This new detailed view of brain organization at the single-cell and functional levels had not been described before, Samee said.

The neural network model approach we have developed in this work presents an instruction manual for other researchers to use to study other areas of the brain or other organs, such as the heart, the main interest of my lab, said co-author Martin, vice chairman and professor of molecular physiology and biophysics, Vivian L. Smith Chair in Regenerative Medicine and director of the Center for Organ Repair and Renewal at Baylor College of Medicine. Martin also is the director of the Cardiomyocyte Renewal Laboratory at the Texas Heart Institute.

Reference: Grisanti Canozo FJ, Zuo Z, Martin JF, Samee MdAH. Cell-type modeling in spatial transcriptomics data elucidates spatially variable colocalization and communication between cell-types in mouse brain. Cell Systems. 2021:S2405471221003410. doi: 10.1016/j.cels.2021.09.004

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

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104 international passengers have tested Covid-19 positive so far: TN Health Minister – The Indian Express

Posted: December 24, 2021 at 2:19 am

As many as 104 people who arrived in Tamil Nadu from various countries have tested Covid-19 positive till date, of whom 82 were detected with the S gene drop variant of coronavirus, state Minister Ma Subramanian said on Wednesday.

The samples of the 82 passengers have been sent to the Institute for Stem Cell Science and Regenerative Medicine (inStem), Bengaluru, for genomic sequencing analysis, the Minister for Medical and Family Welfare said.

All the 82 passengers are fine, he told reporters.

To a query, a health department official told PTI all the 104 passengers comprise of those arriving from at risk and non-risk countries to Tamil Nadu with effect from December 1.

On test samples already sent to inStem, Bengaluru last week, he said the department has received the results of 13 people who were tested, of which one was confirmed to have the Omicron variant of the coronavirus, the delta variant in eight and four non-sequence.

On December 15, Tamil Nadu declared its first Omicron variant of coronavirus, which was a 47 year-old passenger who arrived from Nigeria.

Meanwhile, to step up surveillance at international airports, the government has requested the Centre to allow the health department to conduct COVID-19 tests of all international passengers arriving to Tamil Nadu, as against the current practice of testing those arriving from at risk countries, the minister said.

On the vaccination front, he said the 16th state-wide mega vaccination camp would be held on December 26 (Sunday), targeting 93 lakh people who are eligible to receive the second dose of vaccination.

Earlier in the day, Subramanian declared open digital display boards at the Government Kilpauk Medical College premises, following the announcement made in the state assembly.

In the first phase, 25 government medical college hospitals would be equipped with such digital display boards, totally costing Rs 1.25 crore, which would inform patients about the services offered in the respective hospitals, he said.

The information displayed on the boards would be in Tamil and English, he said.

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Stem Cell Basics – A Closer Look at Stem Cells

Posted: December 24, 2021 at 2:17 am

About stem cells

Stem cells are the foundation of development in plants, animals and humans. In humans, there are many different types of stem cells that come from different places in the body or are formed at different times in our lives. These include embryonic stem cells that exist only at the earliest stages of development and various types oftissue-specific(oradult)stem cells that appear during fetal development and remain in our bodies throughout life.Stem cells are defined by two characteristics:

Beyond these two things, though, stem cells differ a great deal in their behaviors and capabilities.

Embryonic stem cells arepluripotent, meaning they can generate all of the bodys cell types but cannot generate support structures like the placenta and umbilical cord.

Other cells aremultipotent,meaning they can generate a few different cell types, generally in a specific tissue or organ.

As the body develops and ages, the number and type of stem cells changes. Totipotent cells are no longer present after dividing into the cells that generate the placenta and umbilical cord. Pluripotent cells give rise to the specialized cells that make up the bodys organs and tissues. The stem cells that stay in your body throughout your life are tissue-specific, and there is evidence that these cells change as you age, too your skin stem cells at age 20 wont be exactly the same as your skin stem cells at age 80.

Learn more about different types of stem cellshere.

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Corneal epithelial differentiation of human pluripotent stem cells generates ABCB5+ and Np63+ cells with limbal cell characteristics and high wound…

Posted: December 24, 2021 at 2:17 am

Background

Differentiation of functional limbal stem cells (LSCs) from human pluripotent stem cells (hPSCs) is an important objective which can provide novel treatment solutions for patients suffering from limbal stem cell deficiency (LSCD). Yet, further characterization is needed to better evaluate their immunogenicity and regenerative potential before clinical applications.

Human PSCs were differentiated towards corneal fate and cryopreserved using a clinically applicable protocol. Resulting hPSC-LSC populations were examined at days 1011 and 2425 during differentiation as well as at passage 1 post-thaw. Expression of cornea-associated markers including PAX6, ABCG2, Np63, CK15, CK14, CK12 and ABCB5 as well as human leukocyte antigens (HLAs) was analyzed using immunofluorescence and flow cytometry. Wound healing properties of the post-thaw hPSC-LSCs were assessed via calcium imaging and scratch assay. Human and porcine tissue-derived cultured LSCs were used as controls for marker expression analysis and scratch assays at passage 1.

The day 2425 and post-thaw hPSC-LSCs displayed a similar marker profile with the tissue-derived LSCs, showing abundant expression of PAX6, Np63, CK15, CK14 and ABCB5 and low expression of ABCG2. In contrast, day 1011 hPSC-LSCs had lower expression of ABCB5 and Np63, but high expression of ABCG2. A small portion of the day 1011 cells coexpressed ABCG2 and ABCB5. The expression of class I HLAs increased during hPSC-LSCs differentiation and was uniform in post-thaw hPSC-LSCs, however the intensity was lower in comparison to tissue-derived LSCs. The calcium imaging revealed that the post-thaw hPSC-LSCs generated a robust response towards epithelial wound healing signaling mediator ATP. Further, scratch assay revealed that post-thaw hPSC-LSCs had higher wound healing capacityin comparison to tissue-derived LSCs.

Clinically relevant LSC-like cells can be efficiently differentiated from hPSCs. The post-thaw hPSC-LSCs possess functional potency in calcium responses towards injury associated signals and in wound closure. The developmental trajectory observed during hPSC-LSC differentiation, giving rise to ABCG2+ population and further to ABCB5+ and Np63+ cells with limbal characteristics, indicates hPSC-derived cells can be utilized as a valuable cell source for the treatment of patients afflicted corneal blindness due to LSCD.

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Postdoc Position in Bioinformatics in Stem Cell Neurobiology job with MASARYK UNIVERSITY | 276195 – Times Higher Education (THE)

Posted: December 24, 2021 at 2:17 am

Department Department of Histology and EmbryologyFaculty of MedicineDeadline 28 Feb 2022Start date Jully 2022Job type full-timeJob field Science and research

Medical Faculty of Masaryk University, Brno, Czech Republic, invites excellent scientists to apply for

Postdoc position in Bioinformatics in Stem Cell Neurobiology

Description:

The Department of Histology and Embryology is an educational and research workplace at the Medical Faculty of Masaryk University, Brno, the Czech Republic. The Department provides courses on all aspects of normal structure and development of human tissues and organs to students of General medicine and Dentistry. The Department is recognized as premier place in the country for research mainly focusing on human pluripotent stem cells, their biology, and applications in biomedicine.

The successful candidate should:

Specific criteria for this position:

The applicant shall submit:

MU offers the opportunity to get:

Anticipated start date:The position is available from July 2022

The submission deadline is28. February 2022

How to apply:

Please use the "E-Application" link below. After submitting your application, you will receive an automatic confirmation of acceptance via email. For more information, please contact Martina Vrblkov atvrablikova@med.muni.cz.

Areview of applications will commence immediately after the deadline. Short-listed candidates will be invited for interview within one month of the deadline.

Further information about:

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BioRestorative Therapies, Inc. Releases Year-End Message – GlobeNewswire

Posted: December 24, 2021 at 2:17 am

MELVILLE, N.Y., Dec. 20, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company" or BioRestorative) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today released the following year-end message.

As we reach the end of 2021, we are inspired by the many healthcare workers and biopharmaceutical companies that have worked to combat the COVID-19 pandemic. This year has been environmentally difficult, but we have seen incredible advancements in our sector which have reinforced the importance of our mission to become a clinical stage company. Since our emergence from Chapter 11 in 2020, we have sought to take positive steps at BioRestorative Therapies with the goal of making it a preeminent cell therapy company. During 2021, we achieved important transformational milestones, which created meaningful intrinsic value and advanced us toward our stated strategic goals.

In November of this year, we closed on a $23 million capital raise and concurrently listed our securities on the Nasdaq Capital Market. This is a very significant development as we are now fully funded to complete our Phase 2 trial for our lead clinical candidate, BRTX-100, for the treatment of chronic lumbar disc disease (CLDD.) During this process, we have attracted many new institutional fundamental investors as well as some retail investors. With that accomplished, I would like to briefly discuss the status of our programs and the opportunities that lie ahead of us.

BRTX-100 is our lead program for the treatment of CLDD, one of the leading causes of lower back pain. Our solution is a one-time injection of 40 million mesenchymal stem cells derived from a patients own bone marrow and expanded ex vivo before re-injection. Two things make us optimistic about this program. First, in connection with our IND filing, we referred the FDA to prior human clinical studies from different institutions that demonstrated the safety/feasibility of using mesenchymal stem cells to treat disc orders. This data not only enabled us to accelerate our clinical program and initiate a Phase 2 trial, but we believe it substantially reduces risk in offering compelling guidance on the use of cell-based interventions to treat lower back pain. Second, our manufacturing of BRTX-100 involves the use of low oxygen conditions, which ensures that the cells have enhanced survivability after introduction into the harsh avascular environment of the injured disc which has little or no blood flow. The benefits of this process are significant and are illustrated well in our recent Journal of Translational Medicine publication. Our approach is akin to transplant medicine in which specific cell types are used to replace the ones which have been lost to disease. We believe that transplanting targeted cells can offer a more attractive safety profile and potentially an improved clinical outcome. We remain optimistic that we will see significant positive clinical outcomes as we proceed with our clinical trial.

The most significant milestones we achieved in 2021 include:

Our 2022 objectives include the initiation of enrollment for our BRTX-100 clinical trial, the development of our overall product profiles via manufacturing and delivery system improvements, and the entering into of technology validation and enabling partnerships to accelerate our clinical timelines.

Some of the events and milestones that we hope to accomplish in 2022 include:

This is an exciting time to be part of the BioRestorative family. As we enter 2022 with a well-capitalized balance sheet to fully fund our Phase 2 trial, we look to accelerate our research and development pipeline. We do not take for granted that our technologies give us an opportunity to make a profound impact on the everyday lives of many people. We are grateful for the opportunity to validate such technologies; it is what we do and what we believe is the center of our core competencies.

Visit our website atwww.biorestorative.comfor more information about BioRestorative.

Thank you to the BioRestorative family for your loyalty and ongoing support.

I wish you and all those near and dear to you a wonderful Holiday Season and the very best for 2022 and beyond.

Very truly yours,

Lance AlstodtPresident, CEO and Chairman of the Board

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

FORWARD-LOOKING STATEMENTS

This letter contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission (SEC) and other filings made with the SEC. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this letter are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Email: ir@biorestorative.com

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Pork or beef? Stem cells pave the way for lab-grown meat – SYFY WIRE

Posted: December 24, 2021 at 2:17 am

For years, stem cells have been a sort of magic word thrown around as a potential solution for all sorts of challenges in biology and medicine. Certainly, the potential inherent in cells which retain their ability to differentiate into different tissues is nothing to scoff at, but acquiring these cells in a reliable way remains a challenge even decades later.

In order to grow cells in a laboratory setting, researchers rely on additives like fetal calf serum, which is extracted from the coagulated blood drawn from a fetal cow. Once undesired portions of the blood are removed, youre left with a serum which is pretty good at helping cells to grow. The whole process, however, is messy and difficult to duplicate precisely. As a result, we cant be certain that cell lines grown in this way are always the same, something which is necessary when reproducing experiments and is especially important if you want to manufacture lab-grown meat, an increasing area of interest. That problem might now be solved, and lab-grown meats might be on their way to your dinner table.

A recent paper by Ramiro Alberio from the School of Biosciences at the University of Nottingham, and colleagues, describes a new well-defined method for stem cell expansion which could open doors to mass manufacturing of animal tissues for human consumption. Their findings were published in the December issue of Stem Cells and Regeneration.

For industrial applications or food production where regulators require that all components are as defined as possible, current methods have a lot of problems, Alberio told SYFY WIRE. Moving to chemically defined conditions is an important prerequisite for making a product that will enter the food chain.

The team found that only a few key criteria were needed to successfully grow stem cell lines in a lab and, surprisingly, that the same setup was effective in cells from multiple animal species. As a result, one system can grow tissues from cows, pigs, and sheep. In fact, the same criteria also apply to human and mouse cells, providing an added benefit for researchers while were all chowing down on synth-steaks.

We were able to come up with a single unifying recipe for the key components needed by stem cells, Alberio said.

Because researchers are working with stem cells as opposed to muscle cells which have already differentiated theyre able to take a single sample and grow the various tissue types needed to replicate the meat you might find at the grocery store.

Muscle, fat, and connective tissues were all successfully grown in the lab, but this process offers meat with some assembly required. Scientists dont construct those cells into fully-fledged meat products in the lab. Instead, it would be up to consumer companies to take these cellular building blocks and put them together into something you could fry up at a barbecue.

Like your favorite chain restaurant, its important to be able to produce a universal end-user experience free from the guesswork usually associated with stem cell production. Especially as cultured meat products are likely going to be met with some skepticism from the consumer public, scientists want to ensure theyre delivering a product which can be trusted. One of the major benefits of this process is its ability to deliver the same product time after time for at least several years, and probably longer.

These cells are very stable in culture. Weve grown them for about three years, and they are still stable. I wouldnt be able to give a finite number of how many times we can expand these cells though, Alberio said. Over time, cells are likely to acquire chromosomal abnormalities simply because the number of mitotic divisions is so huge. Inevitably there will be aberrations that emerge.

Alberio clarified, however, that those mutations are rare. Over the course of three years, theyve seen very few, but he urged the importance of closely monitoring the cultures and handling them as well as possible to ensure their stability over time. Should a particular line become unstable, it would likely need to be scrapped and replaced with a new sample. One way to minimize mutations is to grow the cells in a low oxygen environment, which is one of the ways this lab differs from others around the world.

We use low oxygen for growing the cells. They grow at 5% oxygen rather than 20%. This helps prevent reactive oxygen species being released in the medium which can have a detrimental effect on the chromosomal integrity. Keeping the cells in the best possible conditions allows us to expand the lifespan considerably.

The unique laboratory setting has other benefits as well, benefits which stand to revolutionize the meat production industry if theyre implemented. Because they are grown in a carefully controlled environment, theres no need for the introduction of antibiotics which are prevalent in factory farming. Alberio also noted the potential positive impact on climate change. Cows are known for their tendency to release methane into the atmosphere which contributes to warming. Globally, livestock are responsible for 14.5 of all greenhouse gases, a number which could be drastically reduced through cultured meat production.

When this technology becomes more mature and streamlined, we should be able to produce meat with no methane emissions whatsoever. There would be some CO2 emissions, but methane would be eliminated from the process of meat production, Alberio said.

The team is now looking to enhance the process by moving from 2D cultures to 3D culture systems which would increase the total volume of tissues they can produce. Theyre also looking at producing cell lines from living animals rather than embryos and culturing cells from specific individuals and breeds.

All of which means that menus of the future might include options from particularly famous animals, well-known for their especially delicious tissues, all while theyre happily living their lives somewhere. Win-win for everyone.

Excerpt from:
Pork or beef? Stem cells pave the way for lab-grown meat - SYFY WIRE

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