Intravenous infusion of autologous mesenchymal stem cells from bone marrow for chronic brain injury patients (PhaseII) - STR01-08

Osamu Honmou, MD, PhD0 sites10 target enrollmentFebruary 15, 2018

Overview

No summary available.

Registry

who.int

Start Date

February 15, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Osamu Honmou, MD, PhD

•\[Inclusion criteria at the time of first registration]
•(1\)Brain injury other than stroke diagnosed by MRI (or CT), MRA (3D\-CTA or DSA) etc (including suspected brain injury other than stroke).
•(2\)Classified as grade 2 to 5 of mRS (modified Rankin scale),and upper limb motor function is lower than 63 points, lower limb motor function is lower than 31 points or balance is lower than 12 points in evaluation of FMA (Fugl\-Meyer Assessment).
•(3\)Age between 20 to 80
•(4\)Rehabilitation can be performed more than 4 units per day.
•(5\)The written informed consent obtained as much as possible from subjects. If the subject does not have ability to write etc, the written informed consent obtained from legal representative alone.
•\[Inclusion criteria at the time of second registration]
•(1\)180 days or more after onset of brain injury other than stroke
•(2\)After rehabilitating more than 4 units per day as much as possible over the past one month or more, there has been no improvement of FMA over the past 2 weeks.
•\* Definition of improvement of FMA : It is improvement of 1 point or more as total point of FMA.

•\[Exclusion criteria at the time of first registration]
•(1\)Severe consciousness disturbance (Japan Coma Scale between 200 and 300\)
•(2\)Severe contracture, deformity or calcification of joint
•(3\)Diagnosed as HBV, HCV or syphilis by initial screening
•(4\)Pancytopenia (WBC \<2000/ uL, Hb \<10\.0g/dl, Plt \<100000/uL)
•(5\)MRI (or CT) revealing severe asymptomatic lesion, white matter lesion
•(6\)MRI revealing multiple and severe microbleeding or hemosiderosis in the whole brain
•(7\)Head and neck MRA (or 3D\-CTA or AG) revealing 70% or more stenosis of main cerebral arteries and cervical carotid arteries even though after revascularization (except complete thrombotic occlusion, except for healed dissecting artery)
•(8\)Head and neck MRA (or CTA or AG) revealing severe arteriosclerotic change and calcification
•(9\)Cerebrovascular diseases with high risk ANs etc such as Moyamoya disease or cerebral aneurysm, other vascular malformations etc