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Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

RecruitingPhase 2Ages 20 Years - 70 YearsAllHokkaido University Hospital
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In plain words

What the trial is, and whether it could suit you

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 o

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ…ข 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 \< 10ยท0 g/dL) 3. Thrombocytopaenia (platelet count \< 100,000/mm3) 4. Severe heart disease (ischaemic heart disease, heart failure) 5. Severe Systemic organ failure ALT \<3ยท0ร— upper limit of normal Total bilirubin \< 1ยท5ร— upper limit of normal Serum creatinine \< 1ยท5ร— 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
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What it tests

  • Stem cell Transplantation
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Where

1 site
Hokkaido University Hospital
Sapporo, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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