Regenerative stem cell therapy for stroke in Europe (RESSTORE): a multicenter randomized controlled efficacy clinical...

Area of Science:

• Regenerative Medicine
• Neuroscience
• Clinical Trials

Background:

• Stroke recovery is a global health challenge.
• Cell-based therapies, particularly with adipose-derived stem cells (ADSCs), show promise for brain repair.
• ADSCs offer a favorable safety profile and potential for functional recovery post-stroke.

Purpose of the Study:

• To evaluate the efficacy and safety of intravenous (IV) infusion of allogeneic ADSCs in patients with ischemic stroke.
• To assess the impact of ADSC therapy on motor recovery and overall clinical outcomes.
• To gather data for designing larger international clinical trials.

Main Methods:

• A multicentric, randomized, double-blind, controlled trial (RESSTORE) enrolling 80 patients.
• Inclusion criteria: acute hemispheric ischemic stroke, NIHSS score ≥7, motor subscore ≥3.
• Treatment: IV infusion of 3 million ADSCs/kg within 10 days of stroke onset, with a 2-year follow-up.

Main Results:

• Primary endpoint: motor NIHSS subscore at 6 months post-stroke.
• Secondary endpoints: safety (death/serious adverse events), comprehensive clinical scores (NIHSS, MoCA, mRS), immune monitoring, and advanced neuroimaging biomarkers.
• Data collection aims to provide evidence for ADSC therapy in subacute stroke.

Conclusions:

• The study will provide evidence on the effects of allogeneic ADSC IV infusion in subacute stroke patients.
• Findings may inform the design of future large-scale international randomized controlled trials.
• This research contributes to advancing cell-based regenerative therapies for stroke recovery.