UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001133 |
|---|---|
| Receipt number | 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 10:02:03 |
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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
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
taguchi@ri.ncvc.go.jp
Sponsor or person
Institute
National Cerbral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001120
