FDA Grants Orphan Drug Designation to Cell Therapy CK0801 for Rare Aplastic Anemia
Cellenkos, Inc. announced that its CK0801, an allogeneic T regulatory cell therapy derived from cord blood, has received Orphan Drug Designation from the FDA for the treatment of aplastic anemia, a rare bone marrow disorder. This designation provides Cellenkos with incentives to further develop CK0801, which has shown promising Phase 1 clinical trial results, including durable transfusion independence in some patients who did not […]
The Future of Stem Cell Transplantation: Insights from Dr. Kevin McNerney
In an era where medical science is rapidly transforming lives, stem cell transplantation stands at the forefront of innovative treatment. At the Bone Marrow Transplant and Gene Therapy Congress in Abu Dhabi, Dr. Kevin McNerney from the Ann & Robert H. Lurie Children’s Hospital in Chicago shares groundbreaking updates and real-world insights into this life-saving […]
Stem Cell Breakthrough: Ryoncil® and the Fight Against a Deadly Childhood Disease
Mesoblast, a leader in cell-based therapies, announced that its product Ryoncil® received coverage from the Centers for Medicare and Medicaid Services (CMS). This agreement ensures access to this newly FDA-approved mesenchymal stromal cell therapy for children with steroid-refractory acute graft versus host disease (SR-aGvHD) covered by Medicaid. Consequently, the first three pediatric patients will begin receiving Ryoncil® treatment this […]
Stem Cell Therapy: A Game-Changer for Brain Injury Recovery
Concussions and brain injuries have long plagued athletes, accident victims, and everyday individuals, often resulting in long-term disabilities and diminished quality of life. However, a promising new treatment—stem cell therapy—may offer a revolutionary path to recovery. One recent case sheds light on the potential of this therapy to restore hope and function for those suffering […]
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 […]