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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035578
Receipt No. 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 2019/08/21

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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
Email 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
Email kudoh@kudohchiaki.com

Sponsor
Institute JAPAN ANGEL STEMCELL
Institute
Department

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
Email 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
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
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 07 Month 02 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
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038614

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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