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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001133
Receipt No. R000001120
Scientific Title Intravenous autologous bone marrow mononuclear cell transplantation for cerebral embolism
Date of disclosure of the study information 2008/05/01
Last modified on 2013/10/25

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Basic information
Public title Intravenous autologous bone marrow mononuclear cell transplantation for cerebral embolism
Acronym Autologous bone marrow mononuclear cell transplantation for stroke
Scientific Title Intravenous autologous bone marrow mononuclear cell transplantation for cerebral embolism
Scientific Title:Acronym Autologous bone marrow mononuclear cell transplantation for stroke
Region
Japan

Condition
Condition cerebral embolism
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Thrombo-occlusive atherosclerotic cardiovascular disease is a major cause of death and disability in developed countries. In the acute phase, therapeutic maneuvers include fibrinolytic therapy and percutaneous coronary intervention to restore blood flow to the ischemic site to reduce the ischemic injury. As well as the prompt reperfusion of the infarct-related coronary artery, restoration of microcirculation at subacute phase through angiogenesis by cell transplantation had been shown to improve the chronic cardiac function in experimental myocardial infarction models. And also, clinical trials of cell therapy using autologous bone marrow cells against myocardial infarction were initiated with promising results. Cerebral infarction is another setting of occlusive thrombo-atherosclerotic disease that prompt reperfusion of the infarct-related artery improves neurological function. Similar to myocardial infarction, restoration of microcirculation after stroke, obtained by intravenous administration of bone marrow mononuclear cells, had been shown to enhance neurological outcome in experimental stroke model.
Based on these observations, we investigate the safety and effect of autologous bone marrow mononuclear cells transplantation in patients with cerebral embolism.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes 1. Improvement of NIHSS (before vs 1 month after cell transplantation)
2. Frequency of change for the worse in NIHSS (before vs 1 month after cell transplantation)
Key secondary outcomes 1. mRS (1, 3 and 6 months after cell transplantation)
2. Barthel Index (1, 3 and 6 months after cell transplantation)
3. NIHSS (1, 3 and 6 months after cell transplantation)
4. Ratio of mRS=0, 1, 2 or 3 at discharge
5. Frequency of hemorrhagic infarction (1 and 6 months after cell transplantation)
6. Frequency of death at discharge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Low dose: Bone marrow 25ml
On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration (only once per patient). Mononuclear cells are purified by Ficoll and administrated intravenously.
Interventions/Control_2 High dose: Bone marrow 50ml
On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration (only once per patient). Mononuclear cells are purified by Ficoll and administrated intravenously.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with cerebral embolism.
2. NIHSS score is more than (or equal to) 10.
3. On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5.
4. Bone marrow aspiration can be done in 10 days after onset of stroke.
Key exclusion criteria 1. Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.
2. Patient who expects brain surgery.
3. Patient with acute myocardial infarction.
4. Patient with coagulation disorder.
5. Number of Platelet < 100000/mm3
6. Serum creatinine level >2.0mg/dl
7. Patient with malignancy.
8. Patient with uncontrolled proliferative diabetic retinopathy.
9. Patient suspected infective endocarditis.
10. HBV, HCV, HIV or HTLV positive.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nagatuka Kazuyuki
Organization National Cerbral and Cardiovascular Center
Division name Department of Cerebrovascular Disease
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565 Japan
TEL 06-6833-5012
Email nagatuka@hsp.ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Taguchi
Organization National Cerbral and Cardiovascular Center
Division name Department of Cerebrovascular Disease
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565 Japan
TEL 06-6833-5012
Homepage URL
Email taguchi@ri.ncvc.go.jp

Sponsor
Institute National Cerbral and Cardiovascular Center
Institute
Department

Funding Source
Organization Ministry of Health, Labour, and Welfare.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Institute of Biomedical Research and Innovation
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 ClinicalTrials.gov Identifier: NCT01028794
Org. issuing International ID_1 U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立循環器病研究センター病院
先端医療センター病院

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
2013 Year 10 Month 31 Day
Date trial data considered complete
2013 Year 11 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 04 Month 25 Day
Last modified on
2013 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001120

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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