UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038614