Phase I/II trial of Intracerebral Transplantation of Autologous Bone Marrow Stromal Cells Combined with Recombinant Peptide Scaffold for Patients with Chronic Intracerebral Hemorrhage

Kawabori Masahito0 sites8 target enrollmentDecember 6, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 6, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kawabori Masahito

•1\. Age between 20 and 70 years
•2\. Clinical diagnosis of intracerebral hemorrhage 12 month or more from onset
•3\. Hemorrhagic location of unilateral basal ganglia or thalamus
•4\. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage III or IV
•5\. No significant neurological impairment before hemorrhage (Pre\-hemorrhagic mRS of 0 or 1\)
•6\. Subjects who can give informed consent by its self

•1\. Severe microbleeds
•2\. Hemorrhagic cavity less than 2 mL
•3\. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
•4\. Subject showing obvious communication between the hemorrhagic cavity and lateral ventricle on MRI
•5\. Subject showing severe lower extremity contracture (Maximum knee extension less than \-15 degrees, Maximum ankle flexion less than 0 degree)
•6\. Subject's body weight less than 45 kg for male and 40kg for female