Clinical Outcomes of Transplanted Modified Bone Marrow-Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study.

ABSTRACT:

Background and purpose

Preclinical data suggest that cell-based therapies have the potential to improve stroke outcomes.

Methods

Eighteen patients with stable, chronic stroke were enrolled in a 2-year, open-label, single-arm study to evaluate the safety and clinical outcomes of surgical transplantation of modified bone marrow-derived mesenchymal stem cells (SB623).

Results

All patients in the safety population (N=18) experienced at least 1 treatment-emergent adverse event. Six patients experienced 6 serious treatment-emergent adverse events; 2 were probably or definitely related to surgical procedure; none were related to cell treatment. All serious treatment-emergent adverse events resolved without sequelae. There were no dose-limiting toxicities or deaths. Sixteen p

SUBMITTER: Steinberg GK 

PROVIDER: S-EPMC5828512 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature