UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035578 |
|---|---|
| Receipt number | R000038614 |
| Scientific Title | Study of searching of Alzheimer's type dementia using the Autologous adipose tissue-derived mesenchymal stem cells |
| Date of disclosure of the study information | 2019/01/18 |
| Last modified on | 2021/07/21 16:21:47 |
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Basic information
Public title
Study of searching of Alzheimer's type dementia using the Autologous adipose tissue-derived mesenchymal stem cells
Acronym
Study of searching of Alzheimer's type dementia using the Autologous adipose tissue-derived mesenchymal stem cells
Scientific Title
Study of searching of Alzheimer's type dementia using the Autologous adipose tissue-derived mesenchymal stem cells
Scientific Title:Acronym
Study of searching of Alzheimer's type dementia using the Autologous adipose tissue-derived mesenchymal stem cells
Region
| Japan |
Condition
Condition
Alzheimer's type dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the Autologous adipose tissue-derived mesenchymal stem cells with Alzheimer's type dementia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Baseline of ADAS-Jcog(Alzheimer's Disease Assessment Scale-cognitive component Japanese version) and change until every 8 weeks and 48weeks
Key secondary outcomes
-Baseline of MMSE and change of 48 weeks
-Baseline of ADL behavior Cognition Dimentia Scale(ABC dimentia Scale) and change until every 8 weeks and 48weeks
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
Adipose derived mesenchymal stem cell infusion therapy (48weeks)
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Persons diagnosed with F3 Probable AD ICD-10 diagnostic criteria using
-MMSE score of 15 to 24
-The patient who can perform fat cell collection of the required amount
Key exclusion criteria
-Patient of deliriousness at the time of screening
-Patient of a dangerously ill organ disorder
-Patient of severe diabetes mellitus, severe cardiac failure and kidney failure
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Kudoh |
Organization
Kudoh Chiaki Neurosurgery clinic
Division name
Director
Zip code
143-0016
Address
1-23-10, Omori-kita, Ota-ku, Tokyo
TEL
03-5767-0226
kudoh@kudohchiaki.com
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Kudoh |
Organization
Kudoh Chiaki Neurosurgery clinic
Division name
Director
Zip code
143-0016
Address
1-23-10, Omori-kita, Ota-ku, Tokyo
TEL
03-5767-0226
Homepage URL
kudoh@kudohchiaki.com
Sponsor or person
Institute
JAPAN ANGEL STEMCELL
Institute
Department
Personal name
Funding Source
Organization
JAPAN ANGEL STEMCELL
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
Kyushu Trinity's Specially Certified Committee for Regenerative Medicine
Address
5-2-3 Nakasu, Hakata-ku, Fukuoka
Tel
092-273-0521
info@trinityclinic.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
医療法人社団くどうちあき脳神経外科クリニック（東京都）
医療法人社団青山会青木病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 18 | 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
10
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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038614
