Stem Cell Stroke Trial Reports Encouraging Early Safety Results

A first-in-human clinical trial has found that intravenous umbilical cord-derived stem cell therapy appears safe and well tolerated in people recovering from ischaemic stroke, providing an important foundation for larger studies.

Researchers treated 18 patients who had experienced an ischaemic stroke between 12 and 24 weeks earlier with a single intravenous infusion of umbilical cord-derived mesenchymal stem cells (UC-MSCs). The phase 1 study primarily assessed safety while also monitoring patients for signs of functional recovery.

No serious adverse events were reported during the 24-week follow-up, although one patient experienced seizures that researchers conservatively classified as possibly treatment related. Other reported side effects, including dizziness, nausea and fatigue, were mild and resolved quickly.

Patients also showed encouraging improvements in neurological function and independence over the six-month follow-up. While these results are promising, researchers caution that the trial was small, had no control group, and was designed to evaluate safety rather than prove effectiveness.

The research team concluded that intravenous UC-MSC therapy is feasible and well tolerated in patients recovering from ischaemic stroke. They say the findings support larger, randomized clinical trials to determine whether the treatment can improve long-term recovery and establish the most effective dosing strategy.

Read more here.