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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGEfficacy of HUNS001-01 administration
The frequency of the improvement in mRS of disability by 1 or more from baseline
Time frame: one year
Safety of HUNS001-01 administration
frequency of Adverse Event
Time frame: one year
Change in NIHSS examination
Mean improvement of NIHSS (0-42, higher score means worse outcome)
Time frame: one year
Change in FIM examination
Mean improvement of FIM (18-126, higher score means better outcome)
Time frame: one year
Change in Fugl-Myer examination
Mean improvement of Fugl-Myer (0-226, higher score means better outcome)
Time frame: one year
Change in Barthal index examination
Mean improvement of Barthal index (0-100, higher score means better outcome)
Time frame: one year
Change in FDG-PET examination
Mean improvement of FDG-PET set for ipsilateral motor cortex
Time frame: one year
Change in IMZ-SPECT examination
Mean improvement of IMZ-SPECT set for ipsilateral motor cortex
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.