Forchheim, Germany Clinical Trials

This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in patients with chronic venous ulcer (CVU). Allogeneic MSCs will be isolated ex vivo and will be expanded in vitro. The IMP incorporating the ...

This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology ...

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic TNBC who had disease progression during or following first-line metastatic treatment with chemotherapy. The study will be performed in two stages. During Stage 1, participants will ...

This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded, Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in subjects with Acute Ischemic Stroke (AIS).

Phase I: The Phase I dose escalation part will establish the MTD/RP2D in subjects with high risk myeloid and lymphoid neoplasms, a total of 3 disease entities. Phase I subjects will be enrolled into the following cohorts and treated with a single intravenous (i.v.) infusion of IMP: Cohort 1: target ...

The main objective of the present study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device ADHD@Home versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder. Furthermore, it is aimed to learn more about the mechanisms underlying NeuroFeedback. The study is prospective, multicentric (9 centres), ...