chronic phase of Ischemic stroke Ischemic stroke, chronic phase
Conditions
Interventions
Intracerebral transplantation of mesenchymal stem cell products (HUNS001-01), collection of platelet fluid and bone marrow fluid for product manufacturing
Sponsors
Fujimura Miki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are at least 20 years old but less than 70 years old at the time of consent (2) Patients who had developed ischemic stroke between 6 months and 5 years ago (3) Patients who has ischmic area in the territory of unilateral interanal cerebral artery (4) Patients with moderate to severe neurological symptoms (modified Rankin Scale 3 or 4 and Brunnstrom Stage III or IV) due to the ischemic stroke (5) Patients with an MRI DTI-RAINBOW (R-DTI) greater than 70%. (6) Patients with pre-mobid modified Rankin Scale of 0 or 1, either by self-reported or family-reported (7) Patients who are able to make the schedule for outpatient visits and hospitalization for this study (8) Patients who can recieve informed consent by itself and who are able to give written consent of their own free will. If the patient is unable to sign the form in person, a substitute author is acceptable.
Exclusion criteria
Exclusion criteria: (1) Patient showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree) (2) Patients with severe anemia (hemoglobin < 10.0 g/dL) or thrombocytopenia (platelet count < 150 x 103 /mcl) (3) Patients with severe cardiovascular complications (ischemic heart disease, heart failure, hypertension, etc.) (4) Patients with severe medical complications (hepatic dysfunction*a*b, renal dysfunction*c, etc.) a. ALT (GPT) or AST (GOT) level more than 3 times the upper limit of the normal b. Total bilirubin level 1.5 times or more than the upper limit of the normal c. Serum creatinine level 1.5 times or more than the upper limit of the normal (5) Patients with a complication or history of malignant tumor disease (6) Patients with positive tests for Syphilis*d, HBV*e, HCV, HIV-1/2, HTLV-1, Parvo virus d. Patients with positive RPR and positive TPLA e. Patients who are HBs antigen positive or HBs antigen negative but either HBs or HBc antibody positive and HBV-DNA quantification is detected. (7) Patient who is pregnant or lactating or expecting to become pregnant during the study period. (8) Patients with serious allergy to any component that may remain in the investigational product (e.g., biologically derived materials used in the manufacturing process, gentamicin, etc.) or to any drug used during administration or testing of the investigational product (9) Patients who are unable to undergo MRI examination due to cardiac pacemakers, metal cardiac prosthetic valves, defibrillators (ICD), etc. (10) Patients with a history of convulsive seizures in the past 2 years (11) Patients whoes body weight less than 45 kg for male and 40kg for female (12) Patients who have participated or are participating in another clinical trial or clinical trial involving an intervention within 90 days prior to obtaining consent. Or, patients who plan to participate in another clinical trial involving an intervention during the study period. (13) Any condition that in the judgement of the investigator would place the patient at undue risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At least 1 point improvement of the modified Rankin Scale after 1 year of treatment (efficiency) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety up to 1 year after transplantation of mesenchymal stem cell products - Safety up to 7 days after transplantation of mesenchymal stem cell products - Safety related to tissue collection (platelet fluid collection and bone marrow fluid collection) - Investigational Product Failures The improvements in the values of the following endpoints will be evaluated. - National Institute of Health Stroke Scale - Barthel Index - Fugl-Meyer Assessment - Timed Up & Go test - 10 m walk - 2-minute walk - Mini-Mental State Examination - Wechsler Adult Intelligence Scale - Fourth Edition - degree of DTI delineation in MRI scan - The relationship between preoperative R-DTI values and functional recovery - Brain glucose metabolism in FDG-PET scan - neuronal receptor function in IMZ-SPECT study | — |
Contacts
Public ContactMiki Fujimura
Hokkaido University Hospital
Outcome results
None listed