Research on Advanced Intervention using Novel Bone marrOW stem cell (RAINBOW): Phase I, open-label, uncontrolled, dose-response trial of autologous bone marrow stromal cell transplantation in patients with acute ischemic stroke - RAINBOW trial

Hokkaido University Hospital0 sites7 target enrollmentFebruary 22, 2017

Conditionsacute ischemic stroke

Overview

Phase: 未知
Intervention: Not specified
Conditions: acute ischemic stroke
Sponsor: Hokkaido University Hospital
Enrollment: 7
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 22, 2017

End Date

September 1, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hokkaido University Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

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