Phase I Trial of Intra-arterial Administration of Autologous Bone Marrow-Derived Mesenchymal Stem Cells in Patients with Multiple System Atrophy.

ABSTRACT:

Background

This study is aimed at investigating the safety and tolerability of the intra-arterial administration of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) in patients with multiple system atrophy- (MSA-) cerebellar type (MSA-C).

Methods

This was a single-center, open-label phase I clinical trial in patients with MSA-C. A three-stage dose escalation scheme (low-dose, 3.0 × 10⁵ cells/kg; medium-dose, 6.0 × 10⁵ cells/kg; high-dose, 9.0 × 10⁵ cells/kg) was applied to determine the maximum tolerated dose of intra-arterial administration of BM-MSCs based on the no-observed-adverse-effect level derived from the toxicity study. The occurrence of adverse events was evaluated 1 day before and 1, 14, and 28 days after BM-MSC the

SUBMITTER: Chung SJ 

PROVIDER: S-EPMC8548132 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature