acute ischemic stroke
Conditions
Interventions
On the day when HUNS001-01 is manufactured, the cell product will be administered to the subject. A dose of 2 x 10^7 cells (400 micro L) will be administered in the low-dose group. HUNS001-01 is impla
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: First screening; 14 days after the onset of stroke 1) Male or female subjects between 20 and 79 years old 2) Informed consent within 14 days after the onset 3) Clinical diagnosis of cerebral ischemic stroke on the internal carotid arterial region 4) Subjects with 0 or 1 in modified Rankin Scale (mRS) before the onset 5) Subjects who can have an informed consent; if insufficiently, legal representative is needed 6) Subjects with moderate or severe neurological symptoms; National Institute of Health Stroke Scale (NIHSS) more than 6, (however, the partial score in both `5. Motor Arm' and `6. Motor Leg' are more than 6) Second screening; 7 days before the administration 1) HUNS001-01 is available within 74 days after the onset 2) Subjects with moderate or severe neurological deficit; mRS>=3
Exclusion criteria
Exclusion criteria: First screening 1) Occurrence of a severe hemorrhagic transformation of ischemic stroke 2) Subjects with deep coma or coma evaluated by Japan Coma Scale (JCS; 300 or 200) 3) Severe anemia (hemoglobin<10.0 g/dL) or thrombocytopenia (platelet count <100,000/mm^3) 4) Severe heart disease (e.g. ischemic heart disease, heart failure) 5) Significant abnormal laboratory tests; a. >3 x ULN for alanine aminotransferase or aspartate aminotransferase b. >1.5 x ULN for total bilirubin c. >1.5 x ULN for serum creatinine 6) Uncontrolled hypertension, despite antihypertensive therapy 7) History of malignancy of any type 8) Carriers of infectious disease as follows: Syphilis, hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2, human T cell leukemia virus (HTLV)-1, or parvovirus B19 9) Subjects who are during pregnancy or want to have children 10) Lactating women 11) Fertile Women who are unable to practice contraception 12) History of seizure or administration of any antiepileptic drugs 13) Contraindication for taking fosphenytoin sodium hydrate 14) Serious allergy to any possible residues in the test product (e.g. any biomaterials used in manufacturing process, gentamicin sulfate, ferucarbotran) or any agents used for the administration of the test product or any inspections during the trial 15) Contraindication for MRI (e.g. a pacemaker, metallic artificial heart valves, an implantable cardioverter defibrillator) 16)Subjects who participate in other clinical trial within 90 days before enrollment. 17) Subjects who are improper on the basis of the judgement by primary investigator or other investigators. Second screening 1-6) The same criteria at first screening 7) Subjects who are improper on the basis of the judgement by primary investigator or other investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of HUNS001-01 administration for 1 year after the intervention: frequency of Adverse Event (AE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of HUNS001-01 administration for 30 days after the intervention: frequency of Adverse Event (AE) Safety of bone marrow aspiration: frequency of Adverse Event (AE) Frequency of the defects of HUNS001-01 at manufacturing Improvement of stroke symptoms for 1 year after the intervention using the following assessment scales: National Institute of Health Stroke Scale (NIHSS) modified Rankin Scale (mRS) Functional Independence Measure (FIM) Barthel Index Fugl-Meyer Assessment Improvement in lesion volume assessed by MRI analysis for 1 year after the intervention Assessment of cell distribution using MRI Assessment of possible functional shift for 1 year after the intervention using FDG-PET and IMZ-SPECT | — |
Countries
Japan
Contacts
Public ContactArisa Miura
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Outcome results
None listed