RecruitingPhase 2NCT06752720

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

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

Sponsor

Hokkaido University Hospital

Enrollment

8 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke, Ischemic Stroke

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

Min Age: 20 YearsMax Age: 70 Years

Inclusion Criteria7

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

Exclusion Criteria13

Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
Anaemia (Hg < 10·0 g/dL)
Thrombocytopaenia (platelet count < 100,000/mm3)
Severe heart disease (ischaemic heart disease, heart failure)
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
History of malignancy
Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
Pregnant or lactating or expecting to become pregnant during the study
Known serious allergy to any agents used in the study
Contraindication for magnetic resonance imaging
History of seizure within 2 years
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"
\. Any condition that in the judgement of the investigator would place the patient at undue risk

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Interventions

DRUGStem 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.