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Jayhawks shine at 2022 Capitol Graduate Research Summit | The University of Kansas – KU Today

Posted: April 19, 2022 at 2:38 am

LAWRENCE Three University of Kansas students received honors during the 19th annual Capitol Graduate Research Summit in Topeka at the end of March. Rohit Singh, Jacob Hodge and Lauren Johnson were each recognized for their outstanding research and presentations at an event that brings together the top graduate student researchers in the state of Kansas.

Rohit Singh, doctoral student in mechanical engineering, received a research award from the Office of Graduate Studies at the Lawrence campus for the project A Novel Technology to Treat Blood-Vessel Related Disease through Space and Time Synchronized Ultrasound and Laser.

A non-visible micron-sized bubble created by ultrasound plus laser inside a blood vessel can treat diseases related to blood vessels, Singh said. It can dissolve blood clots inside vessels in case of deep vein thrombosis disease, and it can close leaky microvessels in the eye to prevent blindness caused by diabetic retinopathy and age-related macular degeneration.

This treatment method aims to improve the human condition and provide a useful alternative to existing treatment techniques that cost anywhere from $15,000 to $20,000 for deep vein thrombosis.

Rohits work explores innovative, non-invasive methods for treating vascular disease, said Jennifer Roberts, vice provost for graduate studies and academic affairs. The procedures he studies would provide preventative treatment for patients with potential blindness due to macular degeneration and diabetic retinopathy.

Jacob Hodge, doctoral student in bioengineering in the M.D.-Ph.D. Medical Scientist Training Program, received a research award from the Office of Graduate Studies at the Lawrence campus for the project Tailoring Stem Cell Therapies to Enhance Regenerative Wound Healing.

My research focuses on using a novel 3D printed biosystem to improve the regenerative capabilities of adult stem cells, Hodge said. Within our bodies, stem cells produce a vast number of compounds that aid in tissue regenerative processes. By utilizing our 3D printed tissue mimetic system, we can control the activity of stem cells and isolate these regenerative compounds to develop personalized medical therapies for a variety of soft tissue ailments, such as wound care.

Hodges research could lead to the development of novel tailorable therapeutics that lessen the economic burden of chronic wounds of patients in the Kansas health care system.

Jacob presented impactful research investigating new techniques for promoting healing for individuals with chronic wounds, Roberts said. Both he and Rohits research showcase the high-quality research underway at KU, and their results show real promise for directly impacting and improving the lives of Kansans.

Lauren Johnson, medical student in the School of Medicine, received a research award from BioKansas and the Office of Graduate Studies at the KU Medical Center for the project Should Breast Cancer Patients Have Preoperative Biopsy of Borderline Abnormal Axillary Lymph Nodes?

Johnsons research has implications for the future treatment of breast cancer patients in Kansas by making treatment more affordable.

The goal of my research project was to determine if a preoperative biopsy of borderline lymph nodes is helpful in the management of breast cancer patients, Johnson said. We found that biopsy is more often an unnecessary procedure as it was only helpful in 32% of patients. We hope this finding can limit travel time, financial burden and unnecessary procedures for breast cancer patients in Kansas.

The free Capitol Graduate Research Summit provides an opportunity for the public as well as Deputy Secretary of Business Development Paul Hughes and state senators and representatives to learn more about the important work of graduate students across the state.

Founded by graduate students 19 years ago, the summit brings attention to the innovative research conducted by students at state universities and emphasizes the public benefits of graduate students research. KU students joined graduate students from Emporia State University, Fort Hays State University, Kansas State University, Pittsburg State University and Wichita State University at the summit.

Top photo:From left to right, Kyung M. Min, Julia Russell, Max S. Fairlamb, Lauren Johnson, Amy Herman, Samantha Cintron, Elizabeth Thoenen, Siddharth Subham, Rohit Singh, Jacob Hodge and Micah Unruh pose after the Capitol Graduate Research Summit. Credit: Genevieve Prescher.Right photo: Jacob Hodge presents his project to Jennifer Roberts, vice provost for Academic Affairs and Graduate Studies.Credit: Genevieve Prescher.

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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress…

Posted: April 19, 2022 at 2:35 am

SUNNYVALE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+). This allows BioCardia to initiate its First-in-Human Phase I/II trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, with trial initiation expected in the third quarter of 2022.

The first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19. "This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies," said Ian McNiece, Ph.D., BioCardias Chief Scientific Officer. "After IV delivery, the cells migrate to the lungs for local therapeutic benefit. We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation in the lungs. Our goal is to help recovering patients with ARDS due to COVID-19 recover faster and more fully, while avoiding longer term respiratory issues."

"In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its potential to provide therapeutic benefit beyond the cardiovascular system," said Peter Altman, Ph.D., Chief Executive Officer. "Our off the shelf MSC platform may have significant advantages over others in clinical development for multiple indications because the MSCs express the biologically important NK1 receptor which binds Substance P. Our in-house clinical cell manufacturing is also expected to be an important strategic asset that enables rapid and cost-effective development."

About ARDS

Acute respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. The fluid keeps the lungs from filling with enough air, which means less oxygen reaches the bloodstream. This deprives organs of the oxygen they need to function. ARDS typically occurs in people who are already critically ill or who have significant injuries. Severe shortness of breath the main symptom of ARDS usually develops within a few hours to a few days after the precipitating injury or infection. Many people who develop ARDS don't survive. The risk of death increases with age and severity of illness. Of the people who do survive ARDS, some recover completely while others experience lasting damage to their lungs1. Based on preliminary clinical reports on COVID-19, respiratory failure complicated by ARDs is the leading cause of death for COVID-19 patients.2 Despite multiple clinical studies, no pharmacological treatments have proven effective for ARDS.3, 4

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in clinical development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS reimbursement. For more information visit:www.BioCardia.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, initiation of our BCDA-04 clinical trial, and the mechanism of action and ease of administration of our NK1R+ MSC therapy.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2022, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

_________________________________________________________________________________________________________

Media Contact:Anne Laluc, MarketingEmail:alaluc@BioCardia.comPhone: 650-226-0120

Investor Contact:David McClung, Chief Financial OfficerEmail:dmcclung@BioCardia.comPhone: 650-226-0120

(1)MayoClinic.Org

(2)Rajagopal K, Keller SP, Akkanti B, et al. Advanced pulmonary and cardiac support of COVID-19 patients, emerging recommendations from ASAIOa living working document. Circ Heart Fail. 2020 May;13(5).

(3)Thompson BT, Chambers RC, Liu KD (2017) Acute respiratory distress syndrome. N Engl J Med 377(19):19041905.

(4)3. Group RC, Horby P, Lim WS et al (2020) Dexamethasone in hospitalized patients with Covid-19preliminary report. N Engl J Med.

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Top Ways To Rejuvenate Your Body And Improve Your Well-being – The Southern Maryland Chronicle

Posted: April 19, 2022 at 2:35 am

Are you feeling run down and exhausted? Do you find yourself struggling to get through the day without a nap? If so, you may need to rejuvenate your body. There are many ways to do this, and this blog post will discuss some of the best methods. It will also talk about how improving your overall well-being can help improve your energy levels and mood. So if youre ready to feel like your old self again, keep reading.

One of the best ways to rejuvenate your body is to consider different types of therapy. This could include things like massages, acupuncture, or even yoga. These therapies can help to relax your muscles and improve your circulation. They can also help to reduce stress levels, which can be a big contributor to fatigue. Massages, in particular, can be very beneficial for improving energy levels. Acupuncture is another great option for those looking to rejuvenate their bodies. This ancient therapy has been used for centuries to help improve overall health. It involves the insertion of thin needles into specific points on the body. This can help to improve circulation and reduce stress levels.

On the other hand, yoga can be a great way to improve flexibility, strength, and stamina. It can also help to clear your mind and reduce stress. You can also consider stem cell therapy, but make sure that you consult with a qualified professional first. This type of therapy can be very beneficial because it can help to repair and regenerate damaged cells. It can also help to improve your overall health and well-being. If youre not sure what type of therapy would be best for you, consider talking to your doctor or a health professional.

Another great way to rejuvenate your body is to eat a healthy diet. This means eating plenty of fruits, vegetables, and whole grains. It also means avoiding processed foods, sugary drinks, and excessive amounts of caffeine. Eating a healthy diet can improve your energy levels, mood, and overall health. It can also help to reduce stress levels and improve your sleep quality. If youre not sure where to start, there are plenty of resources available online and in books. You can also talk to a nutritionist or dietitian for more specific advice.

Exercising regularly is another great way to rejuvenate your body. This is because it can help to improve your circulation, increase your energy levels, and reduce stress. Some of the best exercises for this include walking, running and swimming. However, its important to find an exercise that you enjoy and can stick with. Otherwise, you may not see the benefits. If you need some motivation to get started, consider signing up for a class or hiring a personal trainer. This way, youll be more likely to stick with it.

One of the most important things you can do for your body is to get enough sleep. Most adults need around eight hours of sleep per night. However, many people only get six or seven hours. This can lead to fatigue and other health problems. If youre having trouble sleeping, there are a few things you can try. First, make sure that your bedroom is dark and quiet. This will allow you to relax and fall asleep more easily. Second, avoid using electronics in bed. Finally, establish a regular sleep schedule and stick to it as much as possible.

Finally, strive to make changes in your lifestyle. This means things like reducing stress, quitting smoking, and getting regular exercise. These changes can be difficult to make, but theyre worth it in the long run. Not only will you feel better, but youll also be more likely to stick with them. If you need help making these changes, consider talking to your doctor or a counselor. They will be able to guide you in the right direction. Just make sure that youre ready to commit before you get started.

There are many different ways to rejuvenate your body. However, these are some of the best methods. If youre feeling run down and exhausted, consider trying one or more of these methods. You may find that you have more energy and feel better overall. Improving your well-being can also help to improve your energy levels and mood. So if youre ready to feel like your old self again, start by making some changes to your lifestyle. Rest assured that these simple changes can make a big difference in how you feel.

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Chronic Diseases Is Expected To Have Positive Impact On Stem Cell Characterization Kits Market Demand Bloomingprairieonline – Bloomingprairieonline

Posted: April 19, 2022 at 2:31 am

Stem cell characterization kitst Market sizeis done based on a triangulation methodology that is primarily based on experimental modelling approaches such as patient-level data or disease epidemiology for any key indications , number of procedures and install base analysis for any equipment to obtain precise market estimations for the base year as well as in historic data analysis.

Bottom-up approach is always used to obtain Stem cell characterization kits insightful data for the specific country/regions. The country specific data is again analyzed to derive data at a global level.

Market Overview:-

Stem cells are biological cells that can be converted into specific type of cells as per the bodys requirement. Stem cells are of two types, i.e., adult stem cells and embryonic stem cells. Stem cells can be used to treat various diseases such as cancer, neurodegenerative disorder, cardiovascular disorder and tissue regeneration. Stem cell characterization is the initial step for stem cell research.

Stem cell characterization kit is required to understand the utility of the stem cells in downstream experiments and to confirm the pluripotency of the stem cell.The growth of the stem cell characterization kits market is expected to be being fuelled by government funding for stem cell research.

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Fact.MR, a leading authority on market research brings original, in-depth, and insightful reports to investors On Stem Cell Characterization Kits Market Sales & Demand. Fact.MRs report will highlight various growth forecasts, key trends, and notable segments ripe for upcoming investments.

Key Parameters analyzed while estimating the Stem Cell Characterization Kits market include:

Overall Population by age group/Prevalence or Incidence of any disease/Treatment Seeking Rate/Dosage pattern/Average duration of treatment/Overall treatment cost and Reimbursement are considered.

Overall Population/Prevalence or Incidence of disease/treatment seeking rate/ average duration of the treatment/average number of devices used per patient / average number of procedure per device/ average selling price per device/reimbursement are considered.

Number of Healthcare facilities (Hospitals/Ambulatory Surgical Centers/Clinics etc.)

Average number of devices installed per facilities/ lifespan of the devices/replacement rate of the equipment/new sales of the equipment per year/average selling price per equipment are considered.

Extensive rounds of primary and a comprehensive secondary research have been leveraged by the analysts to arrive at various estimations and projections for Sales & Demand of Stem Cell Characterization Kits, its market share, production footprint, current launches, agreements, ongoing R&D projects, and market strategies.

SWOT analysis has been performed in the Sales study to investigate the strengths, weaknesses, opportunities and threats of each player, both at global and regional levels

Company share analysis is used to derive the size of the global Stem Cell Characterization Kits market. As well as a study of the revenues of companies for the last several years also provides the base for forecasting the market size and its Sales growth rate.

This study offers an overview of the existing market trends, metrics, drivers, and restrictions and also offers a point of view for important segments. The report also tracks product and services demand growth forecasts for the market.

Stem Cell Characterization Kits Market Segmentation:

Based on type of stem cell, the stem cell characterization kits market is segmented into:

Based on application, the stem cell characterization kits market is segmented into:

Based on end user, the stem cell characterization kits market is segmented into:

North America and Europe are expected to witness significant growth in the global stem cell characterization kit market over the forecast period. This is owing to presence of key manufacturers and researchers of stem cell based therapies in these regions. Moreover, manufacturers such as ThermoFisher Scientific, and Becton Dickinson providing stem cell assays are present in North America region.

Asia Pacific is expected to show significant growth in the stem cell characterization kit market over the forecast period, as researchers from China and Japan are working on stem cell based therapies. For instance, in 2017, clinical trials of embryonic stem cells were launched in China for Parkinsons disease.

The Stem Cell Characterization Kits Sales study analyzes crucial trends that are currently determining the growth of Stem Cell Characterization Kits Market.

There is also to the study approach a detailed segmental review. The report mentions growth parameters in the regional markets along with major players dominating the regional growth.

The Key trends Analysis of Stem Cell Characterization Kits also provides dynamics that are responsible for influencing thefuture Sales and Demand of Stem Cell Characterization Kits marketover the forecast period.

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The report covers following Stem Cell Characterization Kits Market insights and assessment that are helpful for all participants involved in the Stem Cell Characterization Kits market:

NOTE:Our team are studying Covid19 and its impact on the Sales growth of Stem Cell Characterization Kits market and where necessary we will consider the Covid-19 footmark for better analysis of the market Demand and industries outlook. Contact us cogently for more detailed information.

Further, the Stem Cell Characterization Kits market Survey report emphasizes the adoption pattern And Demand of Stem Cell Characterization Kits Market across various industries.

The Stem Cell Characterization Kits Sales study offers a comprehensive analysis on diverse features including production capacities, Stem Cell Characterization Kits demand, product developments, Stem Cell Characterization Kits revenue generation and Stem Cell Characterization Kits Market Outlook across the globe.

Competitive Landscape Analysis On Stem Cell Characterization KitsMarket:

In this report, leading market participants involved in the manufacturing of Stem Cell Characterization Kits are covered. Analysis regarding their product portfolio, key financials such as market shares and sales, SWOT analysis and key strategies are included in this report. To provide decision-makers with credible insights on their competitive landscape, the Stem Cell Characterization Kits industry research report includes detailed market competitive landscape analysis.

Some of the key participants in the global Stem Cell Characterization Kits Market include :

Examples of some of the key participants in the stem cell characterization kits market identified across the value chain include Merck KGaA, Celprogen, Inc., Creative Bioarray, Thermo Fisher Scientific Inc., BD Biosciences, R&D Systems, Inc., System Biosciences, Cosmo Bio USA, BioCat GmbH, and DS Pharma Biomedical Co., Ltd.

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After glancing through the report on globalStem Cell Characterization Kits market Demand, readers will get valuable insight into the following:

The Survey report highlights the growth factors and entry barriers for the key players and talks about the new trends emerging in the globalStem Cell Characterization Kitsmarket.

In addition to this, the study sheds light on changing market size, revenue growth, and share of important product segments. Analysts at Fact.MR give prominent data on recent technological developments and product developments in the Stem Cell Characterization Kits Demand during the assessment period.

A comprehensive estimate on Demand of Stem Cell Characterization Kits market has been provided through an optimistic scenario as well as a conservative scenario, taking into account the sales of Stem Cell Characterization Kits market during the forecast period. Price point comparison by region with global average price is also considered in the study.

Market Snapshot

The rising prevalence of cancer, cardiovascular disorders and neurodegenerative diseases and the role of stem cell therapy in treating these diseases is projected to drive the growth of stem cell characterization kit market.

As per the American Cancer Society, in 2017 cancer accounted around 1 out of 4 deaths in the U.S. and was the second most common cause of deaths in the U.S.

Stem cell therapy and stem cell transplant has huge potential to treat such chronic diseases, which is expected to have a positive impact on the growth of the stem cell characterization kits market.

Stem cell transplant is useful for the treatment of spinal cord injury, stroke, and Alzheimers disease, which is expected to fuel the adoption of stem cell characterization kits over the forecast period.

The Stem Cell Agency, California, is working on the development of new stem cell-based therapies for chronic diseases such as cancer and rare diseases, where stem cell characterization kits are primarily required.

Stem cell characterization kit is also required to identify the appropriate stem cells for the treatment of -Thalassemia. Due to the increasing research and study on stem cells, the stem cell characterization kit market is expected to witness significant growth over the forecast period.

The role of stem cell characterization kit is very important because if the stem cells are not characterized properly into required adult cell type, transplanted stem cells may revert back to teratomas and there is a possibility of transplant rejection. This is expected to influence the growth of the stem cell characterization kit market.

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FDA Grants Direct Biologics Regenerative Medicine Advanced Therapy (RMAT) Designation for the use of ExoFlo in COVID-19 Related ARDS USA – English -…

Posted: April 19, 2022 at 2:31 am

AUSTIN, Texas, April 13, 2022 /PRNewswire/ -- Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The RMAT program is designed to expedite the approval of promising regenerative medical products in the US that demonstrate clinical evidence indicating the ability to address an unmet medical need for a serious life-threatening disease or condition. Under the RMAT designation, the FDA provides intensive guidance on drug development and post-market requirements through early and frequent interactions. Additionally, an RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA).

"After intensively reviewing our preclinical data, manufacturing processes, and clinical data from our Phase II multicenter, double blinded, placebo controlled randomized clinical trial, the FDA has recognized ExoFlo as a lifesaving treatment for patients suffering from Acute Respiratory Distress Syndrome (ARDS) due to severe or critical COVID-19," said Mark Adams, Chief Executive Officer. "The additional attention, resources, and regulatory benefits provided by an RMAT designation demonstrate that the FDA views ExoFlo as a product that can significantly enhance the standard of care for the thousands still dying from ARDS every week in the US," he said.

"We are very pleased that the FDA has recognized the lifesaving potential of our platform drug technology ExoFlo. The RMAT has provided a pathway to expedite our drug development to achieve a BLA in the shortest possible time," said Joe Schmidt, President. "I am very proud of our team. Everyone has been working around the clock for years in our mission to save human lives taken by a disease that lacks treatment options, both in the US and abroad. We are grateful for the opportunity to accelerate development of ExoFlo under the RMAT designation as it leads us closer to our goal of bringing our life saving drug to patients who desperately need it."

ExoFlo is an acellular human bone marrow mesenchymal stem cell (MSC) derived extracellular vesicle (EV) product. These nanosized EVs deliver thousands of signals in the form of regulatory proteins, microRNA, and messenger RNA to cells in the body, harnessing the anti-inflammatory and regenerative properties of bone marrow MSCs without the cost, complexity and limitations of scalability associated with MSC transplantation. ExoFlo is produced using a proprietary EV platform technology by Direct Biologics, LLC.

Physicians can learn more and may request information on becoming a study site at clinicaltrials.gov. For more information on Direct Biologics and regenerative medicine, visit: https://directbiologics.com.

About Direct BiologicsDirect Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in San Antonio, Texas. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust EV platform technology. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving segment of next generation regenerative biotherapeutics. Direct Biologics has obtained and is pursuing multiple additional clinical indications for ExoFlo through the FDA's investigational new drug (IND) process. For more information visit http://www.directbiologics.com.

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The Progress Made in Stem Cell Therapy, Regenerative Medicine: Peter J. McAllister, MD, FAAN – Neurology Live

Posted: April 19, 2022 at 2:28 am

WATCH TIME: 2 minutes

The whole concept of regenerative medicine is getting better and growing. The idea that [we could treat] traumatic brain injury, stroke, brain hemorrhage, and then further afield spinal cord injury, Parkinson disease, Alzheimer disease, ALS perhaps. Regenerative medicine is just getting better and better. Were learning more.

At the2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington, phase 2 STEMTRA trial (NCT02416492) investigator Peter J. McAllister, MD, FAAN, presented data that suggest that treatment with SB623, an investigational allogeneic bone marrow-derived modified mesenchymal stem cell therapy developed by SanBio, could be a potential treatment for traumatic brain injury (TBI). STEMTRA assessed the efficacy and safety of SB623 compared with sham surgery in individuals with chronic motor deficits from TBI.

McAllister, a board-certified neurologist and the medical director and chief medical officer of New England Center for Neurology and Headache, spoke with NeurologyLive about these results while in Seattle. He explained that the trial included 61 patients, of whom 46 were treated and 15 underwent sham surgery. Those who received the treatment reported significant gains in motor function measured by Fugl-Meyer Motor Scale scores (8.3 points; SD, 1.4) compared with those who underwent sham (2.3 points; SD, 2.5; P = .04).1

McAllister additionally spoke about some of the data that he was unable to focus on during his presentation. Specifically, he pointed to the astounding effect of the treatment in those who received SB623, as well as the placebo effect that was experienced by patients with deficits who received sham.

Click here for more coverage of AAN 2022.

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AACR: Resistance Mechanisms to CAR-T Cell Therapy ID’d in ALL – HealthDay News

Posted: April 19, 2022 at 2:28 am

TUESDAY, April 12, 2022 (HealthDay News) -- For patients with acute lymphoblastic leukemia with resistance to C19 CAR T-cell therapy, resistance mechanisms that can be detected prior to treatment have been identified, according to a study presented at the annual meeting of the American Association for Cancer Research, held from April 8 to 13 in New Orleans.

Katherine E. Masih, from the National Cancer Institute in Bethesda, Maryland, and colleagues examined differences between resistant and sensitive leukemias using pretreatment bone marrow aspirates from patients enrolled in a clinical trial. Samples were categorized according to patient response; nonresponse was defined as not achieving and maintaining minimal residual disease negativity at day +63. Seven resistant and seven sensitive leukemias were included in the study.

The researchers found that the nonresponders had a distinctive DNA methylation pattern, which was characterized by hypermethylation of PRC2 targets in embryonic and cancer stem cells. Increased accessibility of chromatin was found at regions associated with stem cell proliferation and cell cycling using gene set enrichment analysis of ATAC-seq data. A greater similarity was seen between accessibility patterns of nonresponders to hematopoietic progenitors, including hematopoietic stem cells and common myeloid progenitors. Increased frequency of cell subpopulations expressing a multi-lineage phenotype supported these findings. In addition, relative to responders, there was decreased expression of antigen presentation and processing pathways observed across all leukemic cells.

"Our next steps would be to recapitulate this clinical phenomenon in a mouse model, using different subpopulations of leukemia cells, and then examine if we can overcome this primary resistance with combinatorial or alternative therapies," Masih said in a statement.

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2022-04-18 | NDAQ:BRTX | Press Release | BioRestorative Therapies Inc – Stockhouse

Posted: April 19, 2022 at 2:28 am

MELVILLE, N.Y.,, April 18, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company” or BioRestorative”) (NASDAQ: BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has selected 10 of its 15 clinical sites for its Phase 2 clinical trial targeting chronic lumbar disc disease.

BioRestorative’s Phase 2 trial is a double-blind controlled, randomized study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of BRTX-100. A total of up to 99 eligible patients will be randomized at 15 centers in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion.

The initial 10 clinical sites for the Phase 2 are located across the United States in the following cities:

We are pleased to have selected our initial clinical sites and look forward to initiating patient enrollment”, said Lance Alstodt, the Company’s CEO. The caliber of clinics that have been selected represents some of the best spine care facilities in the country as this selection process represents a major milestone for BioRestorative. We believe that an intradiscal injection of BRTX-100 has the potential to transform the treatment paradigm for patients suffering from chronic lumbar disc disease.”

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 person’s own) cultured mesenchymal stem cells collected from the patient’s 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 patient’s 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 patient’s 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 press release 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. 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 release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT: Email: ir@biorestorative.com

Link:
2022-04-18 | NDAQ:BRTX | Press Release | BioRestorative Therapies Inc - Stockhouse

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Cross-activation of the FGF, TGF- and WNT pathways constrains BMP4-mediated induction of the Totipotent state in mouse embryonic stem cells. -…

Posted: April 19, 2022 at 2:27 am

Abstract: Cell signaling induced cell fate determination is central to stem cell and developmental biology. Embryonic stem cells (ESC) are an attractive model for understanding the relationship between cell signaling and cell fates. Cultured mouse ESCs can exist in multiple cell states resembling distinct stages of early embryogenesis, such as Totipotent, Pluripotent, Primed and Primitive Endoderm. The signaling mechanisms regulating the Totipotent state acquisition and coexistence of these states are poorly understood. Here we identify BMP4 as an inducer of the Totipotent state. However, we discovered that BMP4-mediated induction of the Totipotent state is constrained by the cross-activation of FGF, TGF- and WNT pathways. We exploited this finding to enhance the proportion of Totipotent cells in ESCs by rationally inhibiting these cross-activated pathways using small molecules. Single-cell mRNA-sequencing further revealed that induction of the Totipotent state is accompanied by the suppression of both the Primed and Primitive Endoderm states. Furthermore, the reprogrammed Totipotent cells generated in culture have a molecular and functional resemblance to Totipotent cell stages of preimplantation embryos. Our findings reveal a novel BMP4 signaling mechanism in ESCs to regulate multiple cell states, potentially significant for managing stem cell heterogeneity in differentiation and reprogramming.

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Cross-activation of the FGF, TGF- and WNT pathways constrains BMP4-mediated induction of the Totipotent state in mouse embryonic stem cells. -...

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Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II) -…

Posted: April 19, 2022 at 2:27 am

This article was originally published here

Stem Cells Transl Med. 2022 Apr 18:szac011. doi: 10.1093/stcltm/szac011. Online ahead of print.

ABSTRACT

No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)xerostomia. The objective was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) injected into the major salivary glands of irradiated patients. This open-label, first-in-human, phase 1b, and single-center trial was conducted with repeated measurements days 0, 1, 5, and 30 and 4 months. Eligible patients with objective and subjective signs of radiation-induced salivary gland damage after treatment of oropharyngeal squamous cell carcinoma stages I-II (UICC 8) were enrolled. Twenty-five million cryopreserved AT-MSCs were injected into each submandibular and 50 million AT-MSCs into each parotid gland. Data were collected on adverse events, unstimulated and stimulated whole saliva (UWS and SWS) flow rates and saliva composition, patient-reported outcomes (EORTC QLQ-H&N35 and Xerostomia Questionnaire [XQ]), blood samples and salivary gland scintigraphy. Data were analyzed using repeated measures linear mixed models. Ten patients (7 men, 3 women, 59.5 years [range: 45-70]) were treated in 4 glands. No treatment-related serious adverse events occurred. During 4 months, UWS flow rate increased from 0.13 mL/minute at baseline to 0.18 mL/minute with a change of 0.06 (P = .0009) mL/minute. SWS flow rate increased from 0.66 mL/minute at baseline to 0.75 mL/minute with a change of 0.09 (P = .017) mL/minute. XQ summary score decreased by 22.6 units (P = .0004), EORTC QLQ-H&N35 dry mouth domains decreased by 26.7 (P = .0013), sticky saliva 23.3 (P = .0015), and swallowing 10.0 (P = .0016). Our trial suggests treatment of the major salivary glands with allogenic AT-MSCs is safe, warranting confirmation in larger trials.

PMID:35435231 | DOI:10.1093/stcltm/szac011

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Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II) -...

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