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Intravenous infusion of autologous mesenchymal stem cells from bone marrow for dementia patients: randomized controlled open-label trial (STR01-06)

Intravenous infusion of autologous mesenchymal stem cells from bone marrow for dementia patients: randomized controlled open-label trial

Chiaki Kawanishi, MD, PhD

Sapporo Medical University Hospital

South 1, West 16, Chuo-ku, Sapporo

Masanori Sasaki, MD, PhD

Sapporo Medical University Hospital

South 1, West 16, Chuo-ku, Sapporo

+81-11-611-2111

PENDING

Feb. 06, 2019

Interventional

Randomized controlled open-label trial

open(masking not used)

Yes

2

[Inclusion criteria at the time of first registration]
(1)Dementia that meets the diagnostic criteria for ICD-10, diagnosed by of CT, MRI or cerebral blood flow SPECT etc.
(2)Hospitalizable, mild or moderate dementia (CDR-J 1 or 2)
(3)Age between 20 to 85
(4)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.
(5)Have the same families or cares who can answer to questionnaire in evaluations of trial during trial period.

[Inclusion criteria at the time of second registration]
(1)Hospitalizable, mild or moderate dementia (CDR-J 1 or 2)
(2)Received standard treatment (regardless of the number of drugs or dose) for dementia, but no improvement has been seen.
(3)Ready to infuse of investigational product which satisfies specification of acceptance criteria

[Exclusion criteria at the time of first registration]
(1)Improvement of cognitive function is expected by other treatments such as treatment for endocrine diseases etc.
(2)Diagnosed as HBV, HCV or syphilis by initial screening
(3)Pancytopenia (WBC <2000/uL, Hb <10.0g/dl, Plt <100000/uL)
(4)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
(5)Past history of penicillin and streptomycin allergy or other severe allergy (shock, anaphylactoid symptoms etc.)
(6)Poor general condition due to [Endocrine, nutritional and metabolic diseases, Mental disorders, diseases of nervous system, 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]
(7)Intracranial lesion (severe asymptomatic lesion, severe old infarction, severe white matter lesion, severe multiple lesions, severe microbleeding or multiple hemosiderosis, Cerebrovascular diseases such as Moyamoya disease or high risk AN etc, severe intracerebral hemorrhage etc) including past history of these issues.
(8)70% or more stenosis or dissecting in the artery causing cerebral infarction even though after revascularization (except complete thrombotic occlusion)
(9)Severe arteriosclerotic change and calcification in the blood vessels of head and neck.
(10)Preoperative possible uncontrollable HT under depressor therapy (systolic pressure more than 140mmHg, diastolic pressure more than 90mmHg)
(11)Participation in other clinical trials or past history of cellular therapy
(12)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
(13)Other patients judged by investigators as inappropriate for this study

[Exclusion criteria at the time of second registration]
(1)Improvement of cognitive function is expected by other treatments such as treatment for endocrine diseases etc.
(2)Diagnosed as HBV, HCV, HIV, HTLV-1, syphilis, Human Parvovirus B19 by initial screening
(3)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
(4)Penicillin and streptomycin allergy and other severe allergy (shock, anaphylactoid symptoms etc)
(5)Poor general condition
(6)Intracranial lesion (severe asymptomatic lesion, severe old infarction, severe white matter lesion, severe multiple lesions, severe microbleeding or multiple hemosiderosis, Cerebrovascular diseases such as Moyamoya disease or high risk AN etc, severe intracerebral hemorrhage etc) including past history of these issues
(7)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)
(8)Severe arteriosclerotic change and calcification
(9)Preoperative possible uncontrollable hypertension under depressor therapy
(10)Pregnant, nursing women or those who plan to be pregnant during the study period or male patients who wish partner to get pregnant

etc

Both

Dementia

Intervention type: Name of intervention:Intravenous infusion of autologous mesenchymal stem cells derived from bone marrow Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS DRIP Dose per administration:Max 40mL MSC:0.5*10^8~2*10^8cells/body (maximum dose 3.34*10^6 cells/kg) cells /kg, mL Dosing frequency / Frequency of use:ONCE ONCE Planned duration of intervention:Single dose Intended dose regimen:MSC: 0.5*10^8-2*10^8cells/body (maximum dose 3.34*10^6 cells/kg) maximum volume 40mL detailes of teratment arms:Investigational product and Standard treatment Comparative intervention name:Observation Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:

The difference of ADAS-Jcog between 180 days after injection of the investigational product and just before injection

[Efficacy]
- The value of ADAS-Jcog at 180 days after injection of the investigational product
- The difference of MMSE between 180 days after injection of the investigational product and just before injection
- The value of MMSE at 180 days after injection of the investigational product
- The difference of CDR-J between 180 days after injection of the investigational product and just before injection
- The value of CDR-J at 180 days after injection of the investigational product
- The difference of FAB between 180 days after injection of the investigational product and just before injection
(* The observation group : Replace injection of the investigational product or injection with second registration.)

[Safety]
- All adverse events rate during whole study period

+81-11-611-2111

+81-11-621-8059

Dec. 14, 2017