Approval from Japanese regulators means that trials of induced pluripotent stem cells can begin later this year. Scientists in Japan now have permission to inject ‘reprogrammed’ stem cells into people with spinal-cord injuries. An upcoming trial will mark the first time that induced pluripotent stem (iPS) cells have been used to treat spinal-cord injuries, after
Februray 25, 2019 P.M. Fornasari Tanezumab, an investigational subcutaneously-administered, non-opioid treatment, may benefit patients with moderate to severe chronic low back pain (CLBP), according to top-line results from a Phase 3 study. Study A4091059, a double-blind, placebo- and active-controlled study, included patients with moderate to severe CLBP who had persistent low back pain for more
February 25, 2019 P.M. Fornasari A task force of regenerative medicine experts established by the American Society of Interventional Pain Physicians (ASIPP) has formulated new guidelines for the safe and effective use of biologics in the management of low back pain. The guidelines, published in Pain Physician, are based on a review of the literature on the
The agency clarified the process for development programs for regenerative medicine therapies. Feb 20, 2019 By Pier Maria Fornasari FDA provided further details in February 2019 on how manufacturers may use expedited development programs for regenerative medicine therapies, clarifying that the category includes gene and Chimeric antigen receptor T cells (CAR-T) therapies, as well as cellular
Significant improvement in vision in first cohort of Phase II subjects in US trial of hRPC cell therapy in retinitis pigmentosa ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to provide an update on progress with the ongoing Phase I/II clinical trial of its hRPC cell
Current pricing of Spinraza would require a substantial discount to meet traditional cost-effectiveness ranges; Zolgensma’s value-based price range is between $310,000-$900,000 using standard methodology but as high as $1.5 million using alternative measures of health gain —— As with all treatments for ultra-rare conditions, judgments of overall value require consideration of contextual issues and broader
Allogeneic CAR-Ts could serve an important niche – particularly for patients who can’t receive autologous CAR-Ts – but the earliness of the data makes conclusions tough to draw. Since their transition from small, academic clinical trials to commercial production, CAR-T cell therapies have won recognition as a novel and highly effective therapeutic modality, particularly in
Research led by Johns Hopkins investigators has uncovered the roles of two types of cells found in the vessel walls of fat tissue and described how these cells may help speed bone repair. The study found that one of these perivascular stem cell types, pericytes, induces growth of new blood vessels, while another type, adventicytes,
