Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

Phase 2

Recruiting

• Conditions: Stroke; Stroke, Ischemic; Stroke; Sequelae
• Interventions: Drug: Stem cell Transplantation

• Registration Number: NCT06752720
• Lead Sponsor: Hokkaido University Hospital

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Study First Posted: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-12-31
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell transplantation	Stem cell Transplantation	Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10\^7 MSC cells)

Primary Outcome Measures

Name	Time	Method
Efficacy of HUNS001-01 administration	one year	The frequency of the improvement in mRS of disability by 1 or more from baseline

Secondary Outcome Measures

Name	Time	Method
Safety of HUNS001-01 administration	one year	frequency of Adverse Event
Change in NIHSS examination	one year	Mean improvement of NIHSS (0-42, higher score means worse outcome)
Change in FIM examination	one year	Mean improvement of FIM (18-126, higher score means better outcome)
Change in Fugl-Myer examination	one year	Mean improvement of Fugl-Myer (0-226, higher score means better outcome)
Change in Barthal index examination	one year	Mean improvement of Barthal index (0-100, higher score means better outcome)
Change in FDG-PET examination	one year	Mean improvement of FDG-PET set for ipsilateral motor cortex
Change in IMZ-SPECT examination	one year	Mean improvement of IMZ-SPECT set for ipsilateral motor cortex

Trial Locations

Locations (1)

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan