Houston coronavirus updates: What you need to know about June 14 – msnNOW

9:16 a.m.

Texas reported a record high of 2,242 COVID-19 hospitalizations on Saturday, according to Texas Health and Human Services.

Last week, Texas set a new record for COVID-19 hospitalizations in four of the five days, climbing to 2,166 on Friday.

Health officials are concerned that the increase may strain hospital capacity. Dr. James McCarthy, Chief Physician Executive of Memorial Hermann warned about the recent COVID-19 surge and hospital capacity.

"We need to protect hospital capacity for important healthcare needs," McCarthy said, "The one thing we don't want to see is where hospital capacity is strained in a way where the rest of the patients can't be cared for. Important surgeries still need to go on." Read more details of his interview here.

In an in-depth report by Houston Chronicle's Jenny Deam, Houston hospitals are now ramping up the number of beds and ventilators available. There are nearly 18,000 beds available statewide, an increase of about 4,700 from Thursday. Read more of her in-depth report here.

9:05 a.m.

As of Sunday morning, there are now 7,817,064 cases of the novel coronavirus worldwide, according to Johns Hopkins University. The death toll now has climbed to 430,605. The U.S. currently leads the world with 2,074,749 confirmed cases.

According to Texas Health and Human Services, there are now 86,011 cases reported across the state. Harris County leads the state, reporting 16,188 confirmed cases.

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Houston coronavirus updates: What you need to know about June 14 - msnNOW

Be The Match Appoints Amy Ronneberg as Chief Executive Officer – Southernminn.com

MINNEAPOLIS, June 10, 2020 /PRNewswire/ -- Be The Matchtoday announced the appointment of Amy Ronneberg as chief executive officer (CEO)the first female CEO for the organization. Ronneberg joined Be The Match in 2013 as chief financial officer (CFO) and chief of staff, and has served as acting CEO since February.

Be The Match is a non-profit organization that delivers cures to patients in need of life-saving blood stem cell therapy. The organization operates the national Be The Match Registry,the world's largest and most diverse listing of potential stem cell donors. As trusted leaders in advancing stem cell therapy, Be The Match also provides ground-breaking research, innovative technologies, patient support, and education so even more lives can be saved.

Around the same time Ronneberg joined Be The Match as CFO, she was diagnosed with breast cancer. Now cancer-free, she brings unique passion and perspective to her work.

"As a cancer survivor, I have personally felt what many other cancer patients and their loved ones encounter every day. My experience, the patients we serve, and our outstanding, dedicated employees are my motivation," Ronneberg said. "I am deeply honored to be selected to lead this organization and look forward to further advancing our commitment to providing equal outcomes for all. The recent pandemic has put a spotlight on healthcare inequalities, and we are uniquely positioned to address one glaring disparity that is affecting ethnically diverse patientsthat is the ability to find a matching donor. I look forward to leading our team in diversifying the registry and delivering more life-saving treatments to patients of all backgrounds."

After the Affordable Care Act was implemented, Ronneberg led a Be The Match budget restructure that netted a sustainable $50 million cost reduction and made marrow transplants more affordable. Those efforts and more earned her one of the Minneapolis/St. Paul Business Journal's 2016 CFO of the Year awards. Ronneberg also played a pivotal role in establishing Be The Match's operations in Mexico.

This spring, the Be The Match Board of Directors worked with an outside firm to identify the qualities needed in its next CEO and unanimously agreed that Ronneberg possesses all of them.

"Amy has the perfect blend of business experience, passion and health care expertise to lead Be The Match," said Chair of the Board David L. Porter, M.D. "She likes to say, 'patients first, employees always.' I applaud her commitment to carrying out our mission and putting people first."

Ronneberg is also responsible for Be The Match BioTherapies, which partners with global cell and gene therapy industry leaders to deliver high-quality, consistent and compliant therapies to patients in need. Under her guidance, Be The Match BioTherapies has invested in several therapeutics companies and launched an integrated supply chain platform called MatchSource.

Prior to joining Be The Match, Ronneberg spent 12 years at Capella Education Company where she served as chief accounting officer, vice president of finance and led enterprise-wide operations and customer service. She also worked for Ernst & Young as an audit manager.

Ronneberg has served on several boards and is currently on the board of Magenta Therapeutics (MGTA) and the Finance Committee for Allina Healthcare and the World Marrow Donor Association.

Ronneberg earned a Master of Business Administration from Capella University, Minneapolis, Minn. and a Bachelor of Business Administration in Accounting from University of Wisconsin-Eau Claire.

"Going through treatment with my husband and young children at my side made me a much stronger person, leader and decision maker," Ronneberg said. "Cancer is an unfortunate reality that millions of people have to face, but with support, hope and the right medical tools, it can be overcome."

About Be The MatchFor people with life-threatening blood cancerslike leukemia and lymphomaor other diseases, a cure exists. Be The Match connects patients with their donor match for a life-saving marrow or umbilical cord blood transplant. People can contribute to the cure as a member of the Be The Match Registry, financial contributor or volunteer. Be The Match provides patients and their families one-on-one support, education, and guidancebefore, during and after transplant.

Be The Match is operated by the National Marrow Donor Program (NMDP), a nonprofit organization that matches patients with donors, educates health care professionals and conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), so more lives can be saved. To learn more about the cure, visit BeTheMatch.orgor call 1 (800) MARROW-2.

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Be The Match Appoints Amy Ronneberg as Chief Executive Officer - Southernminn.com

A&B could become premier stem cell producer – Antigua …

ByRobert A. Emmanuel

Officials at the StemCell Medical Center believe that Antigua and Barbuda could become the leadingnation for stem cell export and research.

The centers Chairman,Dr. Bruce Murphy made the disclosure during a press conference on Tuesday.

There is certainlythe potential that, because of the sophisticated nature of the scientificprocesses that we are using, Antigua and Barbuda could be the source of stemcells for a lot of different countries.

Dr. Murphy noted that,for the time being, the facility will be importing stem cells from the UnitedStates.

These stem cells aregoing to be derived from fetal cord blood, which is the part of the umbilicalcord attached to the placenta that is thrown away; it is full of young,healthy stem cells.

It will be sourced inthe US; there are multiple companies right now that take a healthy [young]woman who is pregnant, test her to be sure that she is absolutely healthy and,at the time of an elective caesarean section,get the placenta and the cord blood.

He noted that theimported stem cells will be incubated and stored on island once the clean roomhas been completed in July.

The chairman furtherexplained that the facility will be working with pluripotent stem cells, whichcan develop into bone, cartilage, muscle, an organ tissueliver, kidneyandskin and nervous tissue.

He added that thepluripotent stem cells are looking for a signal from a place in the body thatis generally inflamed and sending out inflammatory signals for them to go toand repair or call in other cells to make new tissue.

He said that everyperson is made out of stem cells and you depend on stem cells every day, yourblood everyday has to depend on stem cells out of your bone marrow to make newred blood cells, new white blood cells, new platelets.

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A&B could become premier stem cell producer - Antigua ...

Nick Cordero Had a ‘Rocky Night’ After He ‘Spiked a Fever’ During His Hospitalization, Wife Says – PopCulture.com

Blue Bloods actor Nick Cordero suffered a "little blip" amid his recovery from coronavirus complications after he recently "spiked a fever," his wife, Amanda Kloots, said in a health update. Taking to her Instagram Story on Tuesday, Kloots opened up about the "bit of a rocky night" her husband experienced as he remains hospitalized in the ICU at Los Angeles' Cedars-Sinai Medical Center.

Addressing fans, who have continued to rally their support around Cordero, Kloots assured that "everything is back to normal today and that was just a little blip that can happen in ICU," PEOPLE reports. She added that her husband is "stable" and "things are going, I think, good." According to Kloots, Cordero had "spiked a fever" overnight, forcing doctors "to do a little bit of fixing of that and antibiotics." She said that they will likely be "looking at doing another, hopefully, CT scan of his lungs to see what kind of progress or if there's further damage in his lungs." Throughout his more than two-month hospitalization, Cordero has suffered a number of setbacks, including lung infections.

Kloots also revealed that doctors will "maybe do another round of stem cells" treatment to help repair and strengthen his lungs. Sharing "exciting news" over the weekend, Kloots had revealed on Sunday that her husband had started stem-cell treatment, expressing her hopes that it would "help repair, strengthen Nick's lungs and get him any better" and possibly bridge "us to the next level in healing for him."

In her Tuesday update, Kloots also opened up about the difficulty of her husband being unable to celebrate and be there as their son, Elvis, turned one. She said that "it breaks my heart" and she "literally can't even talk about it because it makes me so sad." Kloots said that while her husband may not be able to be there with them, she planned "on FaceTiming so he can see Elvis." She admitted that "it's going to be really hard."

Kloots also opened up about her sons birthday in an Instagram post, in which she shared a number of photos from shortly after Elvis was born. Following his birth, Kloots said, Elvis was immediately taken to the ICU "because there was fluid in his lungs." During his two-night stay there, she and her husband "visited him all day" and they "couldn't stop staring at him and eventually holding him." Kloots concluded the post by writing, "My two Cordero men: last June Elvis is in the NICU. This June Nick is in the ICU," adding, "these guys are really trying to take me down."

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Nick Cordero Had a 'Rocky Night' After He 'Spiked a Fever' During His Hospitalization, Wife Says - PopCulture.com

R3 International Now Offering New Stem Cell Therapy Program for Lyme Disease in Mexico – Yahoo Finance

R3 Stem Cell International announced that it is now offering a new program with stem cell therapy for Lyme disease. R3 has been offering effective treatment at its international clinics for a while, but with the new program patients receive more cost effective options with 100 to 200 million stem cells involved.

SAN DIEGO, June 8, 2020 /PRNewswire-PRWeb/ -- R3 Stem Cell International announced that it is now offering a new program with stem cell therapy for Lyme disease. R3 has been offering effective treatment at its international clinics for a while, but with the new program patients receive more cost effective options with 100 to 200 million stem cells involved.

Stem cell treatment for Lyme disease in Mexico has been very effective at helping patients achieve symptom relief and regain an improved quality of life. Depending on a patient's history, the R3 International licensed provider will decide whether to add additional exosomes along with stem cells to the regimen.

The new program for Lyme disease involves either 150 million stem cells or 200 million. While these cell counts are incredibly high, it needs to be noted that the biologics come from a Mexico lab that achieves quality standards that exceed those of the FDA in the US.

There are two options for the Stem Cell Lyme disease program. One is a 5 day stay where Lyme patients receive several treatments during that time. The second option is for a patient to return to the Center for four visits over a year. The decision of which program to participate in is up to the patient and his/her family.

R3 Stem Cell International in Tijuana Mexico is only 20 minutes from the San Diego International Airport. R3 provides concierge escorted transportation to and from the clinic from San Diego, with hundreds of patients over the past year receiving successful care at the modern center.

The stem cell and exosome biologics used for Lyme disease care come from a lab that has an incredible safety record, and each treatment's biologic comes with a full Certificate of Analysis. Because Mexico allows stem cell culturing, the cell counts are extremely high with a viability of over 90%. No preservative is even necessary.

According to R3 International CEO David Greene, MD, MBA, "Patients and their families dealing with Lyme disease deserve a safe, clinically effective and cost effective option. We put that together in Mexico, with all inclusive treatment starting at $8975 which includes hotel and ground transportation. Tough conditions like Lyme disease necessitate large cell counts for optimal outcome, and most international centers charge 3 to 5 times our fees. Not with us!"

Each patient undergoes a free phone consultation with R3 International's licensed, experienced stem cell doctor. Simply call (888) 988-0515 to set one up.

SOURCE R3 Stem Cell International

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R3 International Now Offering New Stem Cell Therapy Program for Lyme Disease in Mexico - Yahoo Finance

Nick Cordero’s Wife Says His COVID-19 Recovery Is ‘Going in the Right Direction’ – countryliving.com

Nick Cordero's wife, Amanda Kloots, shared a hopeful update on her husband's condition as he continues to recover from his battle with COVID-19 and related complications.

In a series of videos posted to her Instagram stories on Sunday, Amanda said, "S0 I think this weekend was a good weekend, it was uneventful. Which, uneventful in the ICU is a good weekend. I think he had a weekend of rest, a weekend of growing, strength in his body and recovering a little bit."

"Not too many changes were made, which is also a good sign, but one really good sign is his white blood count number is way down," she continued. "So it has been as high as 65,000; we are now at 30,000. A frame of reference: a normal healthy person is around 15-20,000, even lower sometimes. So 30,000 is a great sign that things are moving in the right direction."

The Tony Award-nominated Broadway actor has been hospitalized at Cedars-Sinai Medical Center in Los Angeles for more than two months after being diagnosed with COVID-19.

Amanda's optimistic update comes almost a month after her husband woke up from a medically-induced coma and almost two months after he had his right leg amputated due to blood-clotting complications from the virus.

Nick, who is also known for his recurring roles on Blue Bloods and Law & Order: SVU, has started stem cell treatment to help his recovery, Amanda shared in another recent Instagram story.

"This could be really great ... Even if it just bridges us to the next level in healing for him," she said on Friday.

Amanda ended her weekend Instagram stories on a positive note, saying, "I don't know why I just have a really good feeling about this week, so I'm just gonna keep praying for our miracles and keep praying for that healing and God is with us ... Love you!"

We are also praying for Nick's full recovery and wishing him and his family all the best during this difficult time.

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Memorial Sloan Kettering – Hackensack Meridian Health Partnership Announces Funding for Inaugural Immunology Research Collaboration Projects – The…

HACKENSACK, N.J. and NEW YORK, June 5, 2020 /PRNewswire/ -- As part of the Memorial Sloan Kettering Hackensack Meridian Health Partnership, the two organizations have formed an Immunology Research Collaboration. Through this joint initiative, researchers can apply for funding to support innovative investigations to explore the power of the immune system and ways it may be harnessed to fight cancer.

The three researchers with projects selected in 2020 for funding support over one to two years are:

"Immunotherapy has become an essential pillar of cancer treatment, but much remains to be discovered about the immune system and new ways to take advantage of its power to treat cancer effectively," said Paul Sabbatini, M.D., deputy physician-in-chief for clinical research at Memorial Sloan Kettering. "The Immunology Research Collaboration between Memorial Sloan Kettering and Hackensack Meridian Health gives researchers an opportunity to delve deeply into unexplored facets of the immune system, both in the lab and clinic, and speed discoveries that will ultimately contribute to reducing the burden of cancer on our patients, their families, and the world. We are enthusiastic about the potential of these three research projects and look forward to their results."

"While immunotherapy is revolutionizing cancer treatment, its benefits are not always sustainable over the long term," noted Andrew Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center and physician-in-chief of the Hackensack Meridian Health Oncology Care Transformation Service. "The work of these investigators will expand our knowledge of the immune system and glean new insights which may lead to novel immunotherapeutics that are more powerful and more durable than those we are using today. These projects capture the collaborative spirit of this initiative and could have a significant impact on patient outcomes."

ABOUTHACKENSACKMERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children's hospitals - Joseph M. Sanzari Children's Hospital in Hackensack, K. Hovnanian Children's Hospital in Neptune; nine community hospitals Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital Carrier Clinic in Belle Mead; and two rehabilitation hospitals - JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 35,000 team members, and 7,000 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The network's notable distinctions include having four hospitals among the top in New Jersey by U.S. News and World Report. Other honors include consistently achieving Magnet recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker's Healthcare's "150 Top Places to Work in Healthcare/2019" list.

The Hackensack Meridian School of Medicine at Seton Hall University opened in 2018, the first private medical school in New Jersey in more than 50 years, welcomed its second class of 96 students in 2019 to its ON3 campus in Nutley and Clifton. Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit http://www.HackensackMeridianHealth.org.

ABOUT MEMORIAL SLOAN KETTERING

As the world's oldest and largest private cancer center, Memorial Sloan Kettering has devoted more than 135 years to exceptional patient care, influential educational programs, and innovative research to discover more effective strategies to prevent, control and, ultimately, cure cancer. MSK is home to more than 20,000 physicians, scientists, nurses, and staff united by a relentless dedication to conquering cancer. Today, we are one of 51 National Cancer Institute-designated Comprehensive Cancer Centers, with state-of-the-art science and technology supporting groundbreaking clinical studies, personalized treatment, and compassionate care for our patients. We also train the next generation of clinical and scientific leaders in oncology through our continually evolving educational programs, here and around the world. Year after year, we are ranked among the top two cancer hospitals in the country, consistently recognized for our expertise in adult and pediatric oncology specialties. http://www.mskcc.org.

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Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron’s Stem Cells – Yahoo Finance

The Phase 2 study will assess the safety and efficacy of Longeveron's stem cell treatment under Japan's accelerated regulatory pathway for regenerative medicine.

MIAMI, June 1, 2020 /PRNewswire/ --Longeveron LLC announced today that Japan's Pharmaceutical and Medical Devices Agency (PMDA) (the Japanese agency akin to the United States' Food & Drug Administration) approved a Clinical Trial Notification (CTN) application (akin to an Investigational New Drug Application or "IND" in the US regulatory system), approving the initiation of a Phase 2 clinical trial evaluating the safety and efficacy of Longeveron's Mesenchymal Stem Cells (LMSCs) for the treatment of Aging Frailty in Japanese patients. This is another key milestone for Longeveron's Aging Frailty program, which includes two ongoing Phase 2 clinical trials in the U.S.

"We are extremely pleased to achieve this significant milestone," said Geoff Green, President of Longeveron."This study is designed to determine whether the transplant of donor-derived mesenchymal stem cells can improve healthspan in mild to moderately frail patients, thereby improving functionality and potentially lowering their risk of disability, and dependence on others for care."

Aging Frailty is a common, but reversible, life-threatening geriatric condition affecting millions of Japanese over the age of 65.Frail individuals are vulnerable to adverse health outcomes compared to their age-matched peers despite sharing similar comorbidities and demographics.Clinically, frailty manifests as a combination of symptoms that may include loss of muscle and decreased strength, slowed walking (sarcopenia), lower activity and energy levels, poor endurance, nutritional deficiencies, weight loss and fatigue.Collectively, these lead to overall decline in functionality, and increased risk of disability, dependency, and death.

"The biology of frailty is complex, and includes diminished stem cell activity, reduced ability to repair and regenerate tissue, and immunosenescence (deterioration of the immune system) and chronic systemic inflammation," said Dr. Anthony Oliva, Senior Scientist at Longeveron. "LMSCs have multiple mechanisms of action that can potentially address all of these issues, and thus make them extremely attractive as a therapeutic candidate for the unmet medical need of Aging Frailty."

The planned study is an investigator-initiated, randomized, double-blind, placebo-controlled design,and will be conducted at Juntendo University Hospital (Tokyo) and Japan's National Center for Geriatrics and Gerontology (NCGG) in Nagoya.The study's Principal Investigator, Dr. Hidenori Arai, President of the NCGG, commented that "Japan has one of the oldest and fastest aging societies in the world, with nearly 30% of Japan's citizens over the age of 65.Preventing and reversing functional decline associated with frailty is one of the nation's top priorities, and Longeveron's regenerative medicine approach is an exciting and innovative potential therapeutic option.With the disproportionate infection and mortality rate of older people with COVID-19 and Influenza infection, it is critically important to rapidly test treatments that may be effective."

In Japan, the "Pharmaceutical and Medical Device Act" and the "Act on the Safety of Regenerative Medicine" came into effect in 2014. Under this system, a "Time-limited Conditional Approval" option exists, which allows a manufacturer to conditionally sell regenerative medicine products while proceeding with its Phase 3 clinical trial.

Longeveron's Aging Frailty Research Program

Longeveron sponsors the most extensive and advanced Aging Frailty clinical research program in the world, with more than 200 patients treated with LMSCs worldwide.In the U.S., two clinical trials are currently ongoing:

About LMSCs

Longeveron Allogeneic Mesenchymal Stem Cells (LMSCs) is a regenerative medicine product sourced from the bone marrow of young healthy adult donors.LMSCs are culture expanded under the FDA's current good manufacturing practices (cGMP) to high standards, and maintained as individual "off-the-shelf" doses.

About Longeveron LLC

Longeveron (www.longeveron.com) is a regenerative medicine therapy company founded in 2014. Longeveron's mission is to provide biological solutions for aging-related diseases and life-threatening conditions, and is dedicated to developing safe and effective cell-based therapeutics for unmet medical needs such as Aging Frailty, the Metabolic Syndrome, Alzheimer's Disease, Acute Respiratory Distress Syndrome (ARDS) from COVID-19 infection, and congenital heart defects in children (hypoplastic left heart syndrome).

For information please contact:

Paul Lehr, JDplehr@longeveron.com305-338-6257

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longeveron.png LONGEVERON Longeveron - Biological Solutions for Aging

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Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells - Yahoo Finance

Human Mesenchymal Stem Cells (hMSC) Market investigated in the latest research – WhaTech Technology and Markets News

Human Mesenchymal Stem Cells (hMSC) Market Sales 2020-2026

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Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron’s Stem Cells | DNA RNA and Cells | News…

DetailsCategory: DNA RNA and CellsPublished on Monday, 01 June 2020 18:32Hits: 643

The Phase 2 study will assess the safety and efficacy of Longeveron's stem cell treatment under Japan's accelerated regulatory pathway for regenerative medicine.

MIAMI, FL, USA I June 1, 2020 I Longeveron LLC announced today that Japan's Pharmaceutical and Medical Devices Agency (PMDA) (the Japanese agency akin to the United States' Food & Drug Administration) approved a Clinical Trial Notification (CTN) application (akin to an Investigational New Drug Application or "IND" in the US regulatory system), approving the initiation of a Phase 2 clinical trial evaluating the safety and efficacy of Longeveron's Mesenchymal Stem Cells (LMSCs) for the treatment of Aging Frailty in Japanese patients. This is another key milestone for Longeveron's Aging Frailty program, which includes two ongoing Phase 2 clinical trials in the U.S.

"We are extremely pleased to achieve this significant milestone," said Geoff Green, President of Longeveron."This study is designed to determine whether the transplant of donor-derived mesenchymal stem cells can improve healthspan in mild to moderately frail patients, thereby improving functionality and potentially lowering their risk of disability, and dependence on others for care."

Aging Frailty is a common, but reversible, life-threatening geriatric condition affecting millions of Japanese over the age of 65.Frail individuals are vulnerable to adverse health outcomes compared to their age-matched peers despite sharing similar comorbidities and demographics.Clinically, frailty manifests as a combination of symptoms that may include loss of muscle and decreased strength, slowed walking (sarcopenia), lower activity and energy levels, poor endurance, nutritional deficiencies, weight loss and fatigue.Collectively, these lead to overall decline in functionality, and increased risk of disability, dependency, and death.

"The biology of frailty is complex, and includes diminished stem cell activity, reduced ability to repair and regenerate tissue, and immunosenescence (deterioration of the immune system) and chronic systemic inflammation," said Dr. Anthony Oliva, Senior Scientist at Longeveron. "LMSCs have multiple mechanisms of action that can potentially address all of these issues, and thus make them extremely attractive as a therapeutic candidate for the unmet medical need of Aging Frailty."

The planned study is an investigator-initiated, randomized, double-blind, placebo-controlled design,and will be conducted at Juntendo University Hospital (Tokyo) and Japan's National Center for Geriatrics and Gerontology (NCGG) in Nagoya.The study's Principal Investigator, Dr. Hidenori Arai, President of the NCGG, commented that "Japan has one of the oldest and fastest aging societies in the world, with nearly 30% of Japan's citizens over the age of 65.Preventing and reversing functional decline associated with frailty is one of the nation's top priorities, and Longeveron's regenerative medicine approach is an exciting and innovative potential therapeutic option.With the disproportionate infection and mortality rate of older people with COVID-19 and Influenza infection, it is critically important to rapidly test treatments that may be effective."

In Japan, the "Pharmaceutical and Medical Device Act" and the "Act on the Safety of Regenerative Medicine" came into effect in 2014. Under this system, a "Time-limited Conditional Approval" option exists, which allows a manufacturer to conditionally sell regenerative medicine products while proceeding with its Phase 3 clinical trial.

Longeveron's Aging Frailty Research Program

Longeveron sponsors the most extensive and advanced Aging Frailty clinical research program in the world, with more than 200 patients treated with LMSCs worldwide.In the U.S., two clinical trials are currently ongoing:

About LMSCs

Longeveron Allogeneic Mesenchymal Stem Cells (LMSCs) is a regenerative medicine product sourced from the bone marrow of young healthy adult donors.LMSCs are culture expanded under the FDA's current good manufacturing practices (cGMP) to high standards, and maintained as individual "off-the-shelf" doses.

About Longeveron LLC

Longeveron (www.longeveron.com) is a regenerative medicine therapy company founded in 2014. Longeveron's mission is to provide biological solutions for aging-related diseases and life-threatening conditions, and is dedicated to developing safe and effective cell-based therapeutics for unmet medical needs such as Aging Frailty, the Metabolic Syndrome, Alzheimer's Disease, Acute Respiratory Distress Syndrome (ARDS) from COVID-19 infection, and congenital heart defects in children (hypoplastic left heart syndrome).

SOURCE: Longeveron

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Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells | DNA RNA and Cells | News...