Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06752720
PHASE2

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

Sponsor: Hokkaido University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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