Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced positive top-line results from its multinational Phase II clinical study of PLX-PAD cells in the treatment of Intermittent Claudication (IC). PLX-PAD treatment reduced Incidence of revascularization and improved patients’ mobility. Study results also validate the design of Pluristem’s ongoing Pivotal Phase III study in CLI, a more severe stage of peripheral arterial disease (PAD) and confirm Pluristem’s proprietary
New research shows that an immunotherapy called CAR-T cell therapy - currently only effective in treating blood cancer - has the potential to treat solid tumors, such as brain tumors The study, recently published in the Proceedings of the National Academy of Sciences, was led by Dr Misty Jenkins from the Walter and Eliza Institute of Medical Research, Australia. It explains the manner in which CAR-T cell therapy is able
According to the peer-reviewed article in the journal Scientific Reports, placenta-derived cells called PLX cells, exhibit a strong inhibitory effect on various lines of breast, colorectal, kidney, liver, lung, muscle and skin cancers. The research was conducted over more than two years by Pluristem Therapeutics, Inc., a Haifa-based biotechnology company. The article titled “Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF‑a and IFN‑g Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft
Discovery is major step towards a stem cell replacement therapy for Duchenne Muscular Dystrophy UCLA scientists have developed a new strategy to efficiently isolate, mature and transplant skeletal muscle cells created from human pluripotent stem cells, which can produce all cell types of the body. The findings are a major step towards developing a stem cell replacement therapy for muscle diseases including Duchenne Muscular Dystrophy, which affects approximately 1 in
Sernova Corp, a clinical stage company developing regenerative medicine technologies for the long-term treatment of diseases including diabetes and hemophilia, is pleased to announce it has received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (TM) (CPS) in the United States. Sernova plans to initiate the new clinical trial under this US IND to investigate
More than 36 million people globally are affected by type 1 diabetes (T1D), a lifelong disorder where insulin producing cells are attacked and destroyed by the immune system resulting in deficient insulin production that requires daily blood glucose monitoring and administration of insulin. While successful outcomes from islet transplantations have been reported, very few patients can benefit from this therapeutic option due to limited access to cadaveric donor islets. Human
Researchers at the George Washington University (GW) Cancer Center have discovered a new role for the enzyme, histone deacetylase 11 (HDAC11), in the regulation of T-cell function. T-cells can infiltrate tumors with the purpose of attacking the cancer cells. However, prior studies have found that the T-cells group around the tumor, but do not perform the job that they are meant to. "The goal of the T-cell is to destroy
(Reuters) - Novartis AG's (NOVN.S) pioneering cancer drug won the backing of a federal advisory panel on Wednesday, paving the way for the first gene therapy to be approved in the United States. An advisory panel to the Food and Drug Administration voted 10-0 that the drug, tisagenlecleucel, should be approved to treat patients with relapsed B-cell acute lymphoblastic leukemia (ALL), the most common form of U.S. childhood cancer. The
Patients with severe and end-stage heart failure have few treatment options available to them apart from transplants and "miraculous" stem cell therapy. But a new Tel Aviv University study finds that stem cell therapy may, in fact, harm heart disease patients. The research, led by Prof. Jonathan Leor of TAU's Sackler Faculty of Medicine and Sheba Medical Center and conducted by TAU's Dr. Nili Naftali-Shani, explores the current practice of
Researchers have grown heart tissue by seeding a mix of human cells onto a 1-micron-resolution scaffold made with a 3-D printer. The cells organized themselves in the scaffold to create engineered heart tissue that beats synchronously in culture. When the human-derived heart muscle patch was surgically placed onto a mouse heart after a heart attack, it significantly improved heart function and decreased the amount of dead heart tissue. “Our novel
Early proof of efficacy, scalability with cost effective manufacturing, and testability in large Phase III FDA trials are the reasons why TapImmune (TPIV) is the leading T-cell cancer vaccine company and will dominate this space. World class collaborators including the Mayo Clinic, AstraZeneca (AZN), Sloan Kettering and Phase II trial funding from the U.S. Department of Defense prove this point. Vaccines have eradicated numerous infectious diseases. Cancer is vaccine’s next
When a tooth is damaged, either by severe decay or trauma, the living tissues that comprise the sensitive inner dental pulp become exposed and vulnerable to harmful bacteria. Once infection takes hold, few treatment options--primarily root canals or tooth extraction--are available to alleviate the painful symptoms. Researchers at Tufts University School of Dental Medicine (TUSDM) now show that using a collagen-based biomaterial to deliver stem cells inside damaged teeth can
Athersys, Inc. announced that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys’ novel MultiStem® cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys’ planned Phase
Athersys, Inc. got a major nod from Japan’s Pharmaceutical and Medical Devices Agency (PMDA) review of the Clinical Trial Notification (CTN), allowing the commencement by HEALIOS K.K. (Healios) of a confirmatory clinical trial evaluating the safety and efficacy of administration of MultiStem®, Athersys’ novel cell therapy product, for the treatment of ischemic stroke in Japan (also designated by Healios as HLCM051 in Japan). In accordance with the regulatory system in
Novartis AG said it will fold its specialized cell and gene therapies unit into other parts of the company, leading to about 120 job cuts months before seeking approval for a new type of cancer treatment. Cell and gene therapy development will no longer be housed in a separate division, the Basel, Switzerland-based company said Wednesday. The change won’t affect a plan to apply for U.S. approval early next year
Scientists at Sanford Burnham Prebys Medical Discovery Institute (SBP) have made a major advance in understanding how the cells of an organism, which all contain the same genetic information, come to be so diverse. A study published today in Molecular Cell shows that a protein called OCT4 narrows down the range of cell types that stem cells can become. The findings could impact efforts to produce specific types of cells
A new research funding agreement between the Juvenile Diabetes Research Foundation (JDRF) and Sernova, a clinical-stage regenerative medicine biotech, aims to address people with severe type 1 diabetes (T1D) who are hypoglycemia unaware, a condition in which a person with diabetes does not experience the usual early warning symptoms of hypoglycemia (low blood sugar) following an insulin injection. The purpose of the funding is to advance human clinical trials of
