Intravenous infusion of autologous mesenchymal stem cells from bone marrow for chronic brain injury patients (PhaseII)
- Conditions
- Chronic brain injury
- Registration Number
- JPRN-jRCT1090220333
- Lead Sponsor
- Osamu Honmou, MD, PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
[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.
(3)Classified under grade 2 to 5 of mRS (modified Rankin scale)
(4)Ready to infuse of investigational product which satisfies specification of acceptance criteria
[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
(10)Preoperative possible uncontrollable HT under depressor therapy (systolic pressure less than 140mmHg, diastolic pressure less than 90mmHg)
(11)Past history of neoplasms (except CR), severe diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, severe mental and behavioural disorders, severe diseases of the nervous system, severe congenital malformations, deformations and chromosomal abnormalities
(12)Past history of penicillin and streptomycin allergy and other severe allergy (shock, anaphylactoid symptoms etc)
(13)Poor general condition due to [Endocrine, nutritional and metabolic diseases, uncontrollable mental disorders, diseases of nervous system (refractory epilepsy), diseases of circulatory system (uncontrollable and refractory heart failure, moderate or severe valvular heart disorder, uncontrollable and refractory atrial fibrillation, refractory atrial and ventricular thrombus, history of ischemic heart disease and PCI within the past 12 months, serious arrhythmia), diseases of the respiratory system, diseases of the digestive system, diseases of the musculoskeletal system and connective tissue, diseases of the genitourinary system (dialysis etc), injury, poisoning and certain other consequences of external causes etc]
(14)Participating other clinical trial or past history of cellular therapy
(15)Pregnant or possibly pregnant, nursing women or those who plan to be pregnant during the study period or male patients who wish partner to get pregnant
(16)Other patients judged by investigators as inappropriate for this study
[Exclusion criteria at the time of second registration]
(1)Severe consciousness disturbance (Japan Coma Scale between 200 and 300)
(2)Diagnosed as HBV, HCV, HIV, HTLV-1, syphilis, Human Parvovirus B19 by initial screening
(3)Head and neck 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)
(4)Severe arteriosclerotic change and calcification
(5)Cerebrovascular diseases with high risk such as Moyamoya disease, cerebral aneurysm or other vascular malformations etc
(6)Preoperative possible uncontrollable hypertension under depressor therapy
(7)Ischemic heart disease (75% or more stenosis of coronary arteries etc)
(8)Cardiac shunt malformation(VSD, ASD etc)
(9)Possible large thrombus by laboratory examination
(10)Neoplasms (except CR), severe diseases of the blood and blood-forming organs and certain disorde
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of cases that mRS improves one point or more at 180 days after injection of the investigational product from just before injection
- Secondary Outcome Measures
Name Time Method [Efficacy]<br>- The difference of FMA (each item and total score) between 180 days after injection of the investigational product and just before injection<br>- The difference of NIHSS (each item and total score) between 180 days after injection of the investigational product and just before injection<br>- The difference of FIM (each item and total score) between 180 days after injection of the investigational product and just before injection<br> [Safety]<br>- All adverse events rate during whole study period