Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Chronic Ischemic Stroke Phase 2a Clinical Trial

What this Trial Is About

Researchers are evaluating a stem cell transplantation therapy called HUNS001-01 for patients who have had an ischemic stroke in the chronic phase, resulting in moderate to severe neurological disability. This phase 2a clinical trial aims to determine if injecting the patient's own mesenchymal stem cells into the brain can improve disability scores and be safely performed without adverse events over a one-year period. The study focuses on adults aged 20 to 70 years who experienced stroke between 6 months and 5 years prior and have specific neurological impairments. Participants will undergo screening including interviews, blood tests, and imaging to confirm eligibility. Eligible patients will have platelet concentrate and bone marrow harvested, followed by intracerebral transplantation surgery where 40 million autologous stem cells are injected into two brain sites. After surgery, participants will receive rehabilitation and be monitored closely. Follow-up will continue for up to one year or until the trial ends. Throughout the study, participants will undergo regular assessments including neurological evaluations and imaging to track changes and measure the effectiveness of the stem cell treatment. Researchers will monitor safety and neurological recovery using disability scales over the one-year period. The trial includes ongoing observation to detect any side effects and ensure participant well-being during and after the intervention.

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients