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Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Sponsor: Hokkaido University Hospital
Summary
The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are: Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention? Participants will receive the below interventions. * Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging) * Harvest of platelet concentrates (PC) * Harvest of bone marrows (BM) * Receive intracerebral transplantation surgery of HUNS001-01 * Post-operative rehabilitation * Follow-up studies (until 1 year or termination of the trial)
Official title: Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
Key Details
Gender
All
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2024-12-01
Completion Date
2027-11-30
Last Updated
2025-01-24
Healthy Volunteers
No
Conditions
Interventions
Stem cell Transplantation
Manufactured autologous mescenchymal stem cell (HUNS001-01) in our cell processing center will be injected into the brain, totally 4 x 10\^7 cells, in 2 brain sites.
Locations (1)
Hokkaido University Hospital
Sapporo, Hokkaido, Japan