Ex-situ X-ray computed tomography, tension clamp and in-situ transilluminated white light imaging data of non-crimp fabric based fibre composite under fatigue loading

The data published with this paper is obtained during fatigue testing of a unidirectional non-crimp fabric based glass fibre composite by means of ex-situ X-ray CT and in-situ transilluminated white light imaging experiments. The data experimentally shows the damage initiation and progression under fatigue loading both in terms of off-axis cracks in the thin supporting backing fibre bundles and fibre fractures in the load carrying fibre bundles. X-ray CT data comparing the loaded and unloaded state of damage regions by means of a tension clamp solution are also published with this paper

Preclinical quality, safety, and efficacy of a human embryonic stem cell-derived product for the treatment of Parkinson’s disease, STEM-PD

Cell replacement therapies for Parkinson’s disease (PD) based on transplantation of pluripotent stem cell-derived dopaminergic neurons are now entering clinical trials. Here, we present quality, safety, and efficacy data supporting the first-in-human STEM-PD phase I/IIa clinical trial along with the trial design. The STEM-PD product was manufactured under GMP and quality tested in vitro and in vivo to meet regulatory requirements. Importantly, no adverse effects were observed upon testing of the product in a 39-week rat GLP safety study for toxicity, tumorigenicity, and biodistribution, and a non-GLP efficacy study confirmed that the transplanted cells mediated full functional recovery in a pre-clinical rat model of PD. We further observed highly comparable efficacy results between two different GMP batches, verifying that the product can be serially manufactured. A fully in vivo-tested batch of STEM-PD is now being used in a clinical trial of 8 patients with moderate PD, initiated in 2022