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Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

NCT06752720 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-01-24

No results posted yet for this study

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)

Conditions

  • Stroke
  • Stroke, Ischemic
  • Stroke; Sequelae

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.

Sponsors & Collaborators

  • RAINBOW Inc.

    collaborator UNKNOWN

  • Hokkaido University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2027-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06752720 on ClinicalTrials.gov