New data released shows cell and gene therapy manufacturing facilities are rapidly becoming operational reflecting job expansion in the sector. Additional 6,000m2 of cell and gene therapy manufacturing space expected to become available within the next 12 months. The Cell and Gene Therapy Catapult (CGT Catapult) published the sixth annual UK cell and gene therapy
Using organoid technology, adult epithelial stem cells can be expanded in vitro to generate self organizing 3D epithelial structures that closely recapitulate the architecture and cellular composition of the tissue of origin. Because of their strict dependence on Wnt ligands for survival and growth, intestinal organoids have become the tool of choice for in vitro
European regulations might be responsible for lower numbers of advanced therapy clinical trials running in the region when compared to the US and Asia. Europe has historically been a pioneer in advanced therapies, such as cell and gene therapy. Europe was the first region to approve a gene therapy, and it boasts the highest number
Neuromuscular experts with the University of Miami Health System and the Miller School of Medicine will launch a Phase 1/2 clinical trial (NCT04146051) using the CAR-T drug, Descartes-08, to treat patients with generalized myasthenia gravis. Generalized myasthenia gravis (GMG) is a rare disease and a chronic autoimmune condition in which auto-antibodies attack specific proteins at the
Purpose: The primary goal of the present study was to develop the nano-drug consisting of doxorubicin and exosome derived from mesenchymal stem cells, and to explore its effect on osteosarcoma in vitro. Methods: The exosomes were isolated from bone marrow MSCs (BM-MSCs) by an Exosome Isolation Kit. The exosome-loaded doxorubicin (Exo-Dox) was prepared by mixing
Europe has become less competitive than other regions in attracting new ATMP clinical trials. Faster and more streamlined review processes for clinical trials by regulatory authorities are fundamental to increase clinical research and development in Europe. There is considerable country-to-country variability within Europe: the UK has the highest absolute number of new ATMP clinical trials,
Medical science has moved on from the one-size-fits-all approach to the era of personalized medicine. European authorities approved the world’s first-ever gene therapy — GSK’s Strimvelis, a treatment for an inordinately rare inherited disorder characterized by a ravaged immune system, in 2016. So far, the EMA has granted the greatest number of marketing authorizations for
Stem cells of the teeth can contribute to the regeneration of non-dental organs, namely mammary glands. According to a new study from researchers at the University of Zurich, dental epithelial stem cells from mice can generate mammary ducts and even milk-producing cells when transplanted into mammary glands. This could be used for post-surgery tissue regeneration
he Food and Drug Administration has halted a clinical trial of Novartis’ Zolgensma gene therapy due to a safety concern found in an animal study, the company said Wednesday. The hold affects the Novartis (NVS) clinical trial known as STRONG, which was testing a higher dose of Zolgensma administered by spinal injection to older children
AffyImmune Therapeutics, an emerging leader in CAR-T therapies, today announced FDA approval of the company’s investigational new drug (IND) application for AIC100, an affinity-tuned CAR-T cell that received Orphan designation for advanced thyroid cancer. The trial: Phase I study of AIC100 in relapsed and or refractory advanced thyroid cancer and anaplastic thyroid cancer, is sponsored by Weill
