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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• Age between 20 and 70 years

• Clinical diagnosis of ischemic stroke between 6 months and 5 years ago

• Ischemic area in the territory of unilateral interanal cerebral artery

• Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV

• Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging

• No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)

• Subjects who can give informed consent by its self

Locations
Other Locations
Japan
Hokkaido University Hospital
RECRUITING
Sapporo
Contact Information
Primary
Kota Kurisu, M.D., Ph.D.
kkurisu0912@gmail.com
+81-11-706-1161
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 8
Treatments
Experimental: Stem cell transplantation
Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10\^7 MSC cells)
Related Therapeutic Areas
Sponsors
Leads: Hokkaido University Hospital
Collaborators: RAINBOW Inc.

This content was sourced from clinicaltrials.gov

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