Sernova FDA Clearance: Cell Pouch for Hypothyroidism Treatment
Sernova Biotherapeutics has received FDA clearance for its Investigational New Drug (IND) application. This clearance allows them to evaluate their Cell Pouch bio-hybrid organ, combined with autograft thyroid cells, in patients with hypothyroidism undergoing thyroid surgery. The Cell Pouch aims to restore natural thyroid function, eliminating the need for hormone replacement therapy. Preclinical studies showed […]
Celularity and BlueSphere Bio Collaborate on Cell Therapy Manufacturing
Celularity Inc., a cellular medicine company, has entered into a collaboration agreement with BlueSphere Bio (BSB).? Celularity will leverage its manufacturing capabilities to produce BSB’s T cell receptor (TCR) T cell therapies.? This partnership will focus on manufacturing and quality control at Celularity’s New Jersey facility for BSB’s therapies, including a treatment for Acute Myelogenous […]
Longeveron: WHO Approves “Laromestrocel” for Lomecel-Bâ„¢ Stem Cell Therapy
Longeveron Inc. announced that the World Health Organization (WHO) has approved the International Non-proprietary Name (INN) “laromestrocel” for their cellular therapy Lomecel-Bâ„¢? Lomecel-Bâ„¢ is being evaluated as a treatment for Alzheimer?s disease and hypoplastic left heart syndrome (HLHS).? It is a proprietary product made from medicinal signaling cells and has received FDA designations such as […]
GATC Health’s Stem Cell Therapy for Diabetes
GATC Health Corp. announced a groundbreaking stem cell therapy for diabetes, detailed in a recent publication in the American Journal of Biomedical Science & Research. This autologous therapy uses a patient’s own stem cells to potentially treat both Type 1 and Type 2 diabetes, offering improved blood sugar control and reduced medication dependence. The process is […]
Adia Nutrition Enters Global Stem Cell Market – New Clinic in Winter Park, FL
Adia Nutrition, a publicly traded company, has opened a Florida clinic, Adia Med, offering stem cell treatments using ethically sourced umbilical cord stem cells. This clinic aims to provide convenient and FDA-compliant stem cell therapies, comparable to international clinics, for various conditions. The company highlights the quality of its stem cells, the convenience of a […]
CellFE Launches T-REST Kit: Revolutionizing CAR-T Cell Therapy Manufacturing for Breakthrough Cancer Treatments
CellFE, a pioneering biotechnology company, has unveiled its groundbreaking T-REST Resting T Cell Kit, a first-in-class solution designed to revolutionize CAR-T cell therapy manufacturing. This innovative kit aims to enhance the quality and efficacy of CAR-T therapies by optimizing the resting state of T cells, a critical factor in improving patient outcomes. By addressing key […]
NYSCF and Janssen Partner on Neurodegenerative Disease Drug Discovery
The New York Stem Cell Foundation Research Institute (NYSCF) and Janssen Research & Development, a Johnson & Johnson company, have partnered to accelerate the development of precision medicines for neurodegenerative diseases. NYSCF’s AI-powered platform, using automated stem cell systems, will be leveraged to identify new drug targets and therapies. This collaboration combines NYSCF’s expertise in stem cell […]
BioCentriq Expands Cell Therapy Manufacturing
This exciting news in the cell therapy sector could revolutionize how quickly life-changing therapies reach patients. BioCentriq, a leading cell therapy contract development and manufacturing organization (CDMO), is set to expand its operations and establish a cutting-edge cell therapy manufacturing facility in Princeton, New Jersey. This facility will become BioCentriq’s new headquarters, marking a significant […]
Promising Phase 1 Results for Hemophilia A Gene Therapy
Expression Therapeutics announced promising Phase 1 clinical trial results for its novel gene therapy, ET3, treating hemophilia A. The trial, detailed in the New England Journal of Medicine, showed significant increases in Factor VIII levels and a reduction in bleeding events in participants with severe hemophilia A. The therapy uses a lentiviral vector targeting hematopoietic stem […]
FDA Grants Breakthrough Therapy Designation to Seres’ SER-155
Seres Therapeutics announced that the FDA granted Breakthrough Therapy designation to SER-155, their lead investigational drug, for reducing bloodstream infections in adults undergoing stem cell transplants. This designation is based on positive Phase 1b clinical trial data showing a significant reduction in infections compared to a placebo. A meeting with the FDA to discuss the […]