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Updated: Feb 22, 2026
Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
Published on: June 6, 2025
Phase I/II randomized controlled trial of autologous bone marrow-derived mesenchymal stem cell therapy for chronic
Kam Sze Tsang1, Chi Ping Stephanie Ng1, Xian Lun Zhu1
1Department of Surgery, the Chinese University of Hong Kong, Hong Kong, China.
Aim:
To examine the safety and efficacy of mesenchymal stem cell (MSC) therapy for intracerebral haemorrhage with neurological dysfunctions for a year.
Methods:
MSC were ex vivo expanded from 29 mL (17-42 mL) autologous bone marrow. Patients were randomized to have two intravenous injections of autologous MSC or placebos in four weeks apart. Neurological functions and clinical outcomes were monitored before treatment and at 12th, 16th, 24th, 36th and 60th week upon completion of the treatment.
Results:
A mean of 4.57 × 107 (range: 1.43 × 107-8.40 × 107) MSC per infusion was administered accounting to 8.54 × 105 (2.65 × 105-1.45 × 106) per kilogram body weight in two occasions. There was neither adverse event at time of administration nor sign of de novo tumour development among patients after monitoring for a year post MSC therapy. Neuro-restoration and clinical improvement in terms of modified Barthel index, functional independence measure and extended Glasgow Outcome Scale were evident among patients having MSC therapy compared to patients receiving placebos.
Conclusion:
Intravenous administration of autologous bone marrow-derived MSC is safe and has the potential of improving neurological functions in chronic stroke patients with severe disability.
Insights
Mesenchymal stem cell (MSC) therapy for intracerebral hemorrhage showed no adverse events and improved neurological functions in patients with severe disabilities over a one-year period. This regenerative medicine approach offers potential for enhanced recovery in chronic stroke survivors.
Area of Science:
- Regenerative Medicine
- Neuroscience
- Clinical Trials
Background:
- Intracerebral hemorrhage (ICH) frequently results in severe, long-term neurological deficits.
- Current treatments for chronic stroke with severe disability have limited efficacy in restoring neurological function.
Purpose of the Study:
- To evaluate the safety and efficacy of autologous bone marrow-derived mesenchymal stem cell (MSC) therapy.
- To assess the long-term (1-year) outcomes of MSC therapy in patients with ICH-induced neurological dysfunction.
Main Methods:
- Patients received two intravenous infusions of autologous MSCs or placebo, four weeks apart.
- Neurological functions and clinical outcomes were monitored for up to 60 weeks post-treatment.
- Safety was assessed by monitoring for adverse events and tumor development.
Main Results:
- MSC therapy was administered safely, with no adverse events or tumor formation observed during the one-year follow-up.
- Patients treated with MSCs demonstrated significant neuro-restoration and clinical improvement compared to the placebo group.
- Improvements were measured using the modified Barthel index, functional independence measure, and extended Glasgow Outcome Scale.
Conclusions:
- Intravenous administration of autologous bone marrow-derived MSCs is a safe therapeutic option.
- MSC therapy shows potential for improving neurological functions and clinical outcomes in severely disabled chronic stroke patients.
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