chronic ischemic stroke chronic ischemic stroke
Conditions
Interventions
Randomization: Participants will be randomly assigned to either CD34 cell therapy or placebo group with a 1:1 allocation by minimization as dynamic allocation. Randomization will be calculated within
Sponsors
Ohta Tsuyoshi
Kawamoto Atsuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Ischemic stroke of the middle cerebral artery territory 2) Modified Rankin Scale (mRS) score of more than 0 or 1 before the onset of ischemic stroke, and 3 or 4 at the time of signing the consent 3) Onset of between 150 and 365 days at the time of informed consent 4) Change in NIHSS score during the screening period (4 weeks) is 1 or less 5) Both of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score at S1 and S2 are between 15 and 50, and change in FMA-UE score is 5 or less during the screening period. 6) Mini-Mental State Examination (MMSE) score of 24 or more 7) Modified Ashworth scale (MAS) score of the wrist and elbow is 3 or less each. 8) No contraindication to brain magnetic resonance imaging (MRI) 9) Patients who meet the following conditions at screening: WBC count 3,000 to 10,000 per uL, Platelet count greater than or equal to 100,000 per uL, Hemoglobin greater than or equal to 8.0 g per dL, Serum AST or ALT less than or equal to 2.5 times the upper limit of normal, Serum creatinine less than or equal to 1.5 times the upper limit of normal, Serum albumin greater than or equal to 2.5 g per dL 10) Age between 20 and 85 years at the time of signing the consent 11) Female patients of childbearing potential, who have a negative serum or urine pregnancy test and agree to use an adequate method of contraception during the study period 12) Male patients who agree to use an adequate method of contraception during the study period 13) Patient or patient's legally authorized representative has signed an Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) Patients who have undergone endovascular treatment (percutaneous endothelial angioplasty, stenting surgery, etc.) or surgical treatment (carotid endarterectomy, bypass surgery, etc.) within 3 months prior to the time of infrmed consent or are scheduled within the study period 2) Recurrence of ischemic stroke or transient ischemic attack after the first onset of ischemic stroke 3) Patients with hemorrhagic diathesis or abnormal blood coagulation 4) [missing number] (Exclusion criteria deleted) 5) Baseline brain MRI reveals any cerebral aneurysm, Moyamoya disease or Cerebral artery dissection requiring endovascular treatment or surgery on brain MRI 6) Patients with cardiogenic cerebral infarction, who are not properly controlled by anticoagulants 7) Imaging test (including echocardiography, cardiac MRI or cardiac CT) reveals any intracardiac thrombus, atrial myxoma, other cardiac tumor or valve vegitation 8) Patients with non-cardiogenic cerebral infarction, who does not receive any antiplatelet drugs 9) Ischemic stroke of the posterior cerebral artery territory 10) Malignant tumor within 5 years prior to the time of signing the consent 11) Patients undergoing radiation therapy, cancer chemotherapy, or receiving any oral steroids or immunosuppressive drugs 12) Patients who are complicated with the following conditions: Liver cirrhosis and/or clinically significant abnormality in liver function, Uncontrolled endocrine metabolic disorders, New-onset of unstable angina or myocardial infarction after ischemic stroke, Uncontrolled severe arrhythmia (asymptomatic and well controlled atrial fibrillation is permitted), Congestive heart failure (more than or equal to NYHA Grade II) 13) Uncontrolled hypertension (systolic blood pressure more than 160mmHg or diastolic blood pressure more than 100mmHg) 14) Uncontrolled Diabetes mellitus (HbA1c more than 8.0%) 15) Uncontrolled dyslipidemia (total cholesterol more than 400 mg per dL) 16) Allergy or hypersensitivity to human serum albumin 17) History of allergy, hypersensitivity or any serious adverse reaction to G-CSF and apheresis 18) History of allergy, hypersensitivity or any adverse reaction to mouse-derived protein, iron or iron-dextran complex 19) Proliferative diabetic retinopathy 20) Myeloproliferative disease or myelodysplastic syndrome 21) Autoimmune diseases, or patients receiving any oral immunosuppressive drugs 22) History or presence of interstitial pneumonia 23) Screening laboratory tests reveal positivity for hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or human T-cell leukemia virus type 1 or syphilis 24) Abdominal CT reveals a clinically significant splenomegaly 25) History of allergy to contrast agents (more than or equal to Grade 2) 26) History of significant alcohol or drug abuse 27) Patients with psychiatric disease or symptoms, judged as difficulty participating in this study by the investigators 28) Patients who has participated in another clinical study within 3 months prior to signing the consent, or are scheduled to participate in another clinical study during the course of this study 29) Preganant or breastfeeding 30) Patients judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of FMA (upper extremity including hand) score change from baseline(S2) at 24 weeks of study drug adminitration. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are efficacy and safety categories. Efficacy. We will evaluate the efficacy of the investigational drug based on the following parameters: FMA (upper extremity including hand) score: change from baseline at 4 and 12 weeks. FMA (lower extremity) score: change from baseline at 4, 12 and 24 weeks. NIHSS score: change from baseline at 4, 12 and 24 weeks. BRS score: change from baseline at 4, 12 and 24 weeks. MAS score: change from baseline at 4, 12 and 24 weeks. FIM score: change from baseline at 4, 12 and 24 weeks. BI score: change from baseline at 4, 12 and 24 weeks. MMSE score: change from baseline at 4, 12 and 24 weeks. Safety. The safety evaluation indices of this clinical trial are as follows: Adverse events, including adverse event incidence rate, serious, adverse event, grade, and outcome. Laboratory tests change, including hematological examination, blood biochemical examination, and vital signs change. | — |
Contacts
Public ContactNaoko Hagimori
Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe.
Outcome results
None listed