UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040503 |
|---|---|
| Receipt number | 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 | 2024/11/25 18:02:02 |
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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
| 85 | 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 85 years old or less with 0 or 1 in modified Rankin Scale (mRS) before the onset
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 on diffusion weighted MRI
7. Written informed consent by the patient o r a legal representative after thorough under standing after having received sufficient explanation 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 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. There is a prospect that 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
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
mitsuhara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
3
Results
These are three patients with moderate or severe cerebral infarction. In one patient, the patient's condition worsened after surgery and he was not enrolled in the secondary study. The two patients who received the MSCs were male, aged 59 and 85, and neither had any serious complications or drug allergies. There was only one case of D-dimer elevation, Grade 1, in the first case, which was judged to be causally related to autologous skull-derived MSCs, and this event was also allowed to recover.
Results date posted
| 2024 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 31 | Day |
Baseline Characteristics
This study presents the results of autologous skull-derived mesenchymal stem cell administration to two patients with moderate to severe cerebral infarction.
Participant flow
Adverse events
There were no safety issues.
Outcome measures
Although it is difficult to objectively evaluate the efficacy of this treatment because it is a clinical study without historical control, there have been cases of efficacy with cell administration, and we believe that the administration of autologous cranial bone derived MSCs is a safe and effective treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
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
| 2024 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046232
