DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials
The generation of autologous T cells expressing a chimeric antigen receptor (CAR) have revolutionized the field of adoptive cellular therapy. CAR-T cells directed against CD19 have resulted in remarkable clinical responses in patients affected by B-lymphoid malignancies. However, the production of allogeneic CAR-T cells products remains expensive and clinically challenging. Moreover, the toxicity profile of
As more cell therapy products reach the “finish line” of U.S. Food and Drug Administration (FDA) approval and new regenerative medicine products begin the clinical development process, the need for expanded manufacturing capacity that can support long-term commercial business models is increasing. Recently, David Smith, Alex Klarer, Thomas Heathman, Courtney LeBlon, Yasuhiko Tada and Brian
Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually.1 New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production
The technique could greatly increase the number and safety of organ transplants. University of Minnesota researchers are reporting a breakthrough in what has long been viewed as a holy grail in the field of organ transplantation — success without the permanent need for immunosuppressive drugs. Their technique could greatly increase the number and safety of
Perianal fistulizing Crohn’s disease (PFCD) is associated with significant morbidity and might negatively impact the quality of life of CD patients. In the last two decades, the management of PFCD has evolved in terms of the multidisciplinary approach involving gastroenterologists and colorectal surgeons. However, the highest fistula healing rates, even combining surgical and anti-TNF agents,
Cell therapies, in which cellular material is injected, grafted, or implanted into a patient to treat a range of illnesses and medical conditions, are a vital and integral component of medicine today — promising treatment of tissue degenerative diseases, cancer, and autoimmune disorders. However, significant challenges currently exist to prevent its widespread adoption, including problems
The advancement of adoptive cell immunotherapy and the impressive clinical outcomes obtained targeting hematologic malignancies with CAR-T cells dictate for further developments towards a broader use of cellular therapeutics for more patients and more types of malignancy. The advent of iPSC technology provides new perspectives for the manufacturing of customized, tumor-targeting T/NK cells, with improved
tem cell therapies have the potential to treat many conditions, but so far there’s little proof that they do. Even so, clinics around the world offer stem cell-based treatments for a host of medical problems. New research warns that some of these treatments might not be effective and can, in fact, cause harm — sometimes
A study was conducted under the UK Regenerative Medicine Platform as part of the work of the Cell Behaviour, Differentiation and Manufacturing Hub. It comprised part of the Pluripotent Stem Cell Platform (PSCP) project funded by the Medical Research Council, the Biotechnology and Biological Sciences Research Council and the Engineering and Physical Sciences Research Council
