Safety Study of MSC11FCD Stem Cell Therapy Given During Surgery for Patients With Newly Diagnosed Glioblastoma

What this Trial Is About

Researchers are evaluating MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy that expresses a suicide gene, in patients with newly diagnosed glioblastoma, a highly aggressive brain tumor. This phase I clinical trial aims to assess the safety, tolerability, and maximum tolerated dose of MSC11FCD, which is given directly into the tumor site after surgical removal to target remaining tumor cells and potentially reduce early recurrence. The investigational treatment involves administering a single dose of MSC11FCD, delivered intratumorally in amounts of 1x107 or 3x107 cells during surgery using a syringe. The treatment is given immediately following tumor resection to explore its potential as a localized, targeted therapy during the postsurgical period. Participants will be monitored for up to 12 months after treatment to track any adverse events related to the therapy. Assessments include medical imaging and clinical evaluations to observe safety and tolerability. The study also aims to gather preliminary information on the treatments effects, with ongoing follow-up to support patient safety and understand treatment impact over time.

A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma