UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050323 |
|---|---|
| Receipt number | R000057305 |
| Scientific Title | Verification of therapeutic effects and prognosis by mesenchymal stem cell therapy in regenerative medicine and neuro rehabilitation for stroke patients |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2023/08/13 14:37:44 |
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Basic information
Public title
Verification of therapeutic effects and prognosis by mesenchymal stem cell therapy in regenerative medicine and neuro rehabilitation for stroke patients
Acronym
Verification of therapeutic effects and prognosis by mesenchymal stem cell therapy in regenerative medicine and neuro rehabilitation for stroke patients
Scientific Title
Verification of therapeutic effects and prognosis by mesenchymal stem cell therapy in regenerative medicine and neuro rehabilitation for stroke patients
Scientific Title:Acronym
Verification of therapeutic effects and prognosis by mesenchymal stem cell therapy in regenerative medicine and neuro rehabilitation for stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study was to verify therapeutic effects (upper limb function, lower limb function, muscle tone, higher brain function such as attention function, balance ability, gait ability, ADL ability) and prognosis by mesenchymal stem cell therapy in regenerative medicine and neuro rehabilitation for stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment (upper extremity)
Fugl-Meyer Assessment (lower extremity)
Bells test
Timed up & go test
5m walk test
Modified Rankin Scale
Modified Ashworth Scale
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Gene | Device,equipment |
Interventions/Control_1
stroke 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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) stroke patient (ischemic)
2) motor paralysis remains in upper limb or lower limb
3) to receive mesenchymal stem cell therapy
4) informed consent is obtained
Key exclusion criteria
1) no informed consent is obtained
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tamura |
Organization
Okayama Healthcare Professional University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
700-0913
Address
3-2-18 Daiku, Kita-ku, Okayama, Okayama
TEL
086-233-8020
tamura@opu.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tamura |
Organization
Okayama Healthcare Professional University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
700-0913
Address
3-2-18 Daiku, Kita-ku, Okayama, Okayama
TEL
086-233-8020
Homepage URL
tamura@opu.ac.jp
Sponsor or person
Institute
Fukunagakinen Clinic
Institute
Department
Personal name
Funding Source
Organization
Neurotech Medical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukunagakinen Clinic
Address
1-9-33 Chuo, Joto-ku, Osaka, Osaka
Tel
06-6933-7844
xyylll30oecj@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2023 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057305
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
