Hokkaido University Hospital
Sapporo, Hokkaido, 0608638, Japan
Location status: Recruiting
NCT Number: NCT06752720
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)
Interested in participating?
Request Info20 year–70 year
All sexes
Interventional
Phase 2
Sapporo, Hokkaido, 0608638, Japan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: one year
The frequency of the improvement in mRS of disability by 1 or more from baseline
Time frame: one year
frequency of Adverse Event
Time frame: one year
Mean improvement of NIHSS (0-42, higher score means worse outcome)
Time frame: one year
Mean improvement of FIM (18-126, higher score means better outcome)
Time frame: one year
Mean improvement of Fugl-Myer (0-226, higher score means better outcome)
Time frame: one year
Mean improvement of Barthal index (0-100, higher score means better outcome)
Time frame: one year
Mean improvement of FDG-PET set for ipsilateral motor cortex
Time frame: one year
Mean improvement of IMZ-SPECT set for ipsilateral motor cortex
Contact information is provided by the study sponsor or research team.
Hokkaido University Hospital
Other
Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
Acronym: RAINBOW-2a
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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