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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040503
Receipt No. R000046232
Scientific Title The study of intravenous administration of autologous cranial bone derived mesenchymal stem cells for moderate or severe cerebral infarction patients needed decompressive surgery
Date of disclosure of the study information 2020/06/01
Last modified on 2020/11/24

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Basic information
Public title The study of intravenous administration of autologous cranial bone derived mesenchymal stem cells for moderate or severe cerebral infarction patients needed decompressive surgery
Acronym Administration of autologous cranial bone derived mesenchymal stem cells for cerebral infarction
Scientific Title The study of intravenous administration of autologous cranial bone derived mesenchymal stem cells for moderate or severe cerebral infarction patients needed decompressive surgery
Scientific Title:Acronym The study of intravenous administration of autologous cranial bone derived mesenchymal stem cells for moderate or severe cerebral infarction patients needed decompressive surgery
Region
Japan

Condition
Condition cerebral infarction
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase I,II

Assessment
Primary outcomes Safety for three month after intravenous administration of autologous cranial bone derived me senchymal stem cells
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intravenous administration of autologous cranial bone derived mesenchymal stem cells for cerebral infarction patients
Interventions/Control_2
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
80 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria at the time of first registration
1. First unilateral cerebral hemisphere infarction including the territory of middle cerebral artery
2. Cerebral infarction diagnosed by MRI (or CT) , MRA (or CTA, cerebral angiography), electrocardiogram, chest lesion examination, etc.
3. Male or female between 20 years old or older and less than 80 years old with 0 or 1 in modified Rankin Scale (mRS) before the ons et
4. National Institutes of Health stroke scale ( NIHSS) score >= 15
5. Decrease in the level of consciousness to a score of 1 or greater on item 1a of the NIHSS
6. Signs on CT of an infarct of at least 50% of the MCA territory, with or without additional infarction in the territory of the anterior or posterior cerebral artery on the same side, or infarct volume >145 cm3 as shown ondiffusion weighted MRI
7. Written informed consent by the patient o r a legal representative after thorough under standing after having received suffiicient exp lanation about this clinical study

Inclusion criteria at the time of Secondary registration
1. Informed consent by the patient or a legal representative from a free will after through under standing of this clinical study and sufficient under standing before cell transplantation
Key exclusion criteria Exclusion criteria at the time of first registrations
1. Out of standard treatment course in initial treatment of cerebral infarction until surgical decompression (severe hemorrhagic transformation of ischemic lesion, etc.)
2. Other serious illness with contraindication for surgical decompression
3. Positivity for hepatitis B virus , hepatitis C virus , HIV, or human T-cell lymphotropic virus type 1 or syphilis at the initial screening
4. Significant risk for recurrence of cerebral infarction
5. Active or unstable intracranial lesions such as moyamoya disease, cerebral aneurysms at high risk of causing rupture or embolism, and severe intracranial hemorrhage .
6. Other serious comorbidity that could affec t outcome ( presence of a malignant tumor , uncontrolled proliferative diabetic retinopathy, etc.)
7. Serious allergy to any possible residues in the test product ( e .g . any biomaterials used in manufacturing process , and gentamicin sulfate ) or any agents used for the administration of the test product or any inspections during the trial
8. Significant abnormal laboratory tests ( severe medical complications such as kidney dysfunction, liver dysfunction, etc.)
9. Participate in other clinical trial
10. Pregnant or possibly pregnant, lactating women, fertile women who are unable to practice contraception
11. Improper on the basis of the judgement by primary investigator or other investigators

Secondary registration selection exclusion criteria
1. Deep coma or coma evaluated by Japan Coma Scale (JCS; 300 or 200)
2.Out of the standard course of treatment for preceding cerebral infarction
3. Autologous cranial bone derived mesenchymal stem cells that do not meet shipping criteria in post-production quality inspection not available
4. Improper on the basis of the judgement by primary investigator or other investigators
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Takafumi
Middle name
Last name Mitsuhara
Organization Hiroshima University
Division name Department of Neurosurgery, Graduate School of Biomedical and Health Sciences
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, HIROSHIMA 734-8551, JAPAN
TEL 082-257-5227
Email mitsuhara@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Takafumi
Middle name
Last name Mitsuhara
Organization Hiroshima University
Division name Department of Neurosurgery, Graduate School of Biomedical and Health Sciences
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, HIROSHIMA 734-8551, JAPAN
TEL 082-257-5227
Homepage URL
Email mitsuhara@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization TWO CELLS Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Certified Committee for Regenerative Medicine, Hiroshima University
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Japan, Hiroshima
Tel 082-257-5908
Email iryo-seisaku@office.hiroshima-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTb060190041
Org. issuing International ID_1 Ministry of Health, Labour and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 06 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 Open public recruiting
Date of protocol fixation
2020 Year 02 Month 25 Day
Date of IRB
2020 Year 03 Month 09 Day
Anticipated trial start date
2020 Year 03 Month 19 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 24 Day
Last modified on
2020 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046232

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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