Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients (RAINBOW-2a)

January 22, 2025 updated by: Hokkaido University Hospital

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608638
        • Recruiting
        • Hokkaido University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Age between 20 and 70 years
  2. Clinical diagnosis of ischemic stroke between 6 months and 5 years ago
  3. Ischemic area in the territory of unilateral interanal cerebral artery
  4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
  5. Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
  6. No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)
  7. Subjects who can give informed consent by its self

Exclusion criteria

  1. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
  2. Anaemia (Hg < 10·0 g/dL)
  3. Thrombocytopaenia (platelet count < 100,000/mm3)
  4. Severe heart disease (ischaemic heart disease, heart failure)
  5. Severe Systemic organ failure ALT <3·0× upper limit of normal Total bilirubin < 1·5× upper limit of normal Serum creatinine < 1·5× upper limit of normal
  6. History of malignancy
  7. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
  8. Pregnant or lactating or expecting to become pregnant during the study
  9. Known serious allergy to any agents used in the study
  10. Contraindication for magnetic resonance imaging
  11. History of seizure within 2 years
  12. Subject's body weight less than 45 kg for male and 40kg for female "13. Participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future"

14. Any condition that in the judgement of the investigator would place the patient at undue risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stem cell transplantation
Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10^7 MSC cells)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of HUNS001-01 administration
Time Frame: one year
The frequency of the improvement in mRS of disability by 1 or more from baseline
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hokkaido University Hospital

Collaborators

RAINBOW Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R6-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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