DetailsCategory: DNA RNA and CellsPublished on Monday, 01 June 2020 18:32Hits: 295
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
Read more from the original source:
- Mesenchymal stem cell based therapies for uveitis: a systematic review of preclinical studies | Eye - Nature.com - April 10th, 2024
- Development of exosome therapy to treat inflammatory bowel disease by VesiCURE Therapeutics - StreetInsider.com - April 10th, 2024
- Adipose Derived Stem Cell Therapy Market Will Show the Highest Growth Rates, Incredible Demand by 2031 - WhaTech - April 3rd, 2024
- Injectable microspheres adhering to the cartilage matrix promote rapid reconstruction of partial-thickness cartilage defects - ScienceDirect.com - March 30th, 2024
- Safety and Potential Effect of Intrauterine Infusion of Autologous Adipose Tissue-Derived Regenerative Cells in ... - Cureus - March 30th, 2024
- Instructing iPS cell-derived mesenchymal stem cells to inhibit abnormal bone formation in FOP - Medical Xpress - March 28th, 2024
- Clinical application of mesenchymal stem cell in regenerative medicine ... - March 22nd, 2024
- Mesenchymal Stem Cells: The Past Present and Future - March 22nd, 2024
- CytoMed Diversifies into Regenerative Medicine after Research Collaboration with Singapore's Sengkang General ... - Yahoo Finance - March 20th, 2024
- Overexpression of Wnt5a promoted the protective effect of mesenchymal stem cells on Lipopolysaccharide-induced ... - BMC Infectious Diseases - March 20th, 2024
- Mesenchymal Stem Cells: What We Have Learned and How to Manage Them - MDPI - March 17th, 2024
- Mesenchymal stem cells and their microenvironment - March 17th, 2024
- Mesenchymal stem/stromal cells as a valuable source for the treatment ... - March 17th, 2024
- Proteomic characterization of hUC-MSC extracellular vesicles and evaluation of its therapeutic potential to treat ... - Nature.com - March 13th, 2024
- The impact understanding of exosome therapy in COVID-19 and preparations for the future approaches in dealing with ... - Nature.com - March 13th, 2024
- CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to ... - Yahoo Finance UK - March 7th, 2024
- CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to ... - Yahoo Finance - March 6th, 2024
- Combatting osteoarthritis with cartilage replacement therapy - Drug Target Review - March 3rd, 2024
- Ethical considerations in Stem Cell therapy for ALS - Cyprus Mail - February 27th, 2024
- Therapeutic Solutions International Files Patent on Facilitating Effects of JadiCells on Gene Therapy Mediated Cell ... - Business Wire - February 27th, 2024
- Stem Cell Therapy for Ulcerative Colitis - Health Central - February 27th, 2024
- Expanding the Horizons of Cell and Gene Therapy - RegMedNet - February 24th, 2024
- Early differentiation of mesenchymal stem cells is reflected in their dielectrophoretic behavior | Scientific Reports - Nature.com - February 22nd, 2024
- Orthopaedics Department's Regenerative Research Highlighted at ORS Annual Meeting - InventUM - University of Miami - February 20th, 2024
- Cellular uptake and in vivo distribution of mesenchymal-stem-cell-derived extracellular vesicles are protein corona ... - Nature.com - February 18th, 2024
- New University spin-out developing novel adult stem cell-based Therapies - News - University of Liverpool - News - February 15th, 2024
- Examining the potential of the common bovine as a potential therapeutic research model - Medical Xpress - February 15th, 2024
- Intentional Interference: Genetic Engineering Medium Aids The Transfection Of MSCs With siRNA - BioProcess Online - February 15th, 2024
- Cellular senescence is associated with osteonecrosis of the femoral head while mesenchymal stem cell conditioned ... - Nature.com - February 9th, 2024
- Stem Cell Therapy for Crohns Disease Shows Promising Results - RegMedNet - February 9th, 2024
- Targeted transcriptomic analysis of synovial tissues from horses with septic arthritis treated with immune-activated ... - American Veterinary Medical... - February 7th, 2024
- Mesenchymal Stem Cell Immunomodulation: Mechanisms and ... - Cell Press - February 7th, 2024
- New Cell Therapy for ARDS: A Groundbreaking Development and Other Respiratory Health Breakthroughs - Medriva - February 7th, 2024
- Effective treatment of optic neuropathies by intraocular delivery of MSC-sEVs through augmenting the G-CSF ... - pnas.org - January 31st, 2024
- Global Stem Cell Therapy Industry Outlook to 2028, Driven by Therapeutic Innovations and Clinical Advancements ... - Yahoo Finance - January 29th, 2024
- Out-of-this-world study will test how stem cells function in space - YP - January 29th, 2024
- The Applications of Cell Therapy - Technology Networks - January 26th, 2024
- STEM CELL THERAPY FOR MS COST: WHAT YOU NEED TO KNOW? - Island Echo - January 24th, 2024
- Understanding Neuromyelitis Optica: Role of NF-B and Therapeutic Potential - Medriva - January 20th, 2024
- Faculty member Arnold Caplan passes away The Daily The Daily - The Daily | Case Western Reserve University - January 18th, 2024
- Effects of fine particulate matter on bone marrow-conserved hematopoietic and mesenchymal stem cells: a systematic ... - Nature.com - January 11th, 2024
- Expression of HLA-DR by mesenchymal stromal cells in the platelet lysate era: an obsolete release criterion for MSCs ... - Journal of Translational... - January 11th, 2024
- NurOwn and its exosomes for ALS given patents in Europe, elsewhere - ALS News Today - January 8th, 2024
- Single-cell analysis reveals the stromal dynamics and tumor-specific characteristics in the microenvironment of ovarian ... - Nature.com - January 8th, 2024
- First in Class Combination Stem Cell and Exosome Therapy to Treat Pulmonary Fibrosis in Long Haul Covid Patients ... - Yahoo Finance - January 4th, 2024
- Choosing the Right Excipients for MSC and iPSC Therapies - Pharmaceutical Technology Magazine - January 4th, 2024
- Mitochondria Transplantation Therapy It's Farther Along Than You Think - BioProcess Online - January 2nd, 2024
- Embryonic-stem-cell-derived mesenchymal stem cells relieve experimental contact urticaria by regulating the functions ... - Nature.com - December 21st, 2023
- Type I collagen and fibromodulin enhance the tenogenic phenotype of hASCs and their potential for tendon ... - Nature.com - December 19th, 2023
- Could the 'central dogma' of biology be misleading bioengineers? - Phys.org - December 13th, 2023
- The Risks of Stem Cell and Exosome Treatments for Long COVID: A Call for Stricter Regulations - Medriva - December 13th, 2023
- Mesenchymal stem cells from biology to therapy - PMC - December 11th, 2023
- The Safety and Efficacy of Human Umbilical Cord-Derived ... - Cureus - December 5th, 2023
- The pivotal role of Nrf2 signal axis in IDD | JIR - Dove Medical Press - December 5th, 2023
- Futuristic Novel Therapeutic Approaches in the Treatment of ... - Cureus - December 3rd, 2023
- Cartilage's Contribution in Otology: A Comprehensive Review of Its ... - Cureus - December 3rd, 2023
- Mesenchymal stem or stromal cells: a review of clinical applications ... - November 29th, 2023
- Comparative evaluation of 3D-printed and conventional implants in ... - Nature.com - November 29th, 2023
- Expression of E-cadherin and N-cadherin in Epithelial-to ... - Cureus - November 29th, 2023
- Enhancing the immunosuppressive properties of human umbilical cord mesenchymal stem cells - Phys.org - November 29th, 2023
- 'Great Potential' in Stem Cell Therapies for Knee Osteoarthritis ... - Pain News Network - November 25th, 2023
- Dietary Sources, Bioavailability, and Functions of Ascorbic Acid ... - Cureus - November 25th, 2023
- FY 2024 VA-Funded Projects - VA's Office of Research and Development - November 25th, 2023
- Real-world data suggest effectiveness of the allogeneic ... - Journal of Translational Medicine - November 23rd, 2023
- Mesenchymal Stem Cells: Characteristics, Function, and Application - November 23rd, 2023
- Combined application of therapeutic viruses and nanomaterials to ... - News-Medical.Net - November 23rd, 2023
- Progress in the Development of Stem Cell-Derived Cell-Free ... - Dove Medical Press - November 23rd, 2023
- Improving the therapeutic efficacy of oncolytic viruses for cancer ... - Journal of Translational Medicine - November 23rd, 2023
- 11.22.23 -- How To Lose A Batch In 10 Days - BioProcess Online - November 23rd, 2023
- The Pros and Cons of Mesenchymal Stem Cell-Based Therapies - November 19th, 2023
- Leptin's influence on MMP-1 expression | JIR - Dove Medical Press - November 15th, 2023
- TWIST1 and TSG6 are coordinately regulated and function as ... - Science - November 11th, 2023
- Association between severe acute malnutrition in childhood and ... - BioMed Central - November 11th, 2023
- Global Market for Treatments for Syndromes of Progressive Ataxia and Weakness Disorders - Yahoo Finance - November 11th, 2023
- Stem Cell Restore Reviews - Does It Work? Real Green Valley ... - The Daily World - November 11th, 2023
- Biological and genetic characterization of a newly established ... - Nature.com - November 11th, 2023
- Placental Stem Cell Collection and Storage Industry Scope ... - Argyle Report - November 9th, 2023
- In Vitro Evaluation of Light-Induced Cytotoxic Property: Synergistic ... - Cureus - November 9th, 2023
- UF professor launches nonprofit to equalize cell-based therapy access - Mainstreet Daily News Gainesville - November 7th, 2023
- Who are the leading innovators in cell immunomodulation for the ... - Pharmaceutical Technology - November 7th, 2023
Recent Comments