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

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 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

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

Value
https://center6.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