Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

NCT ID: NCT06752720

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-11-30

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)

Conditions

Stroke; Stroke, Ischemic; Stroke; Sequelae

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem cell transplantation

Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10\^7 MSC cells)

Group Type: EXPERIMENTAL

Stem cell Transplantation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RAINBOW Inc.

UNKNOWN

Sponsor Role: collaborator

Hokkaido University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Kota Kurisu, M.D., Ph.D.

Role: CONTACT

kkurisu0912@gmail.com

+81-11-706-1161 ext. 5987

Facility Contacts

Kota Kurisu, M.D., Ph.D.

Role: primary

kkurisu0912@gmail.com

81-11-706-1061 ext. 5987

Other Identifiers

R6-8

Identifier Type: -

Identifier Source: org_study_id