UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053551 |
|---|---|
| Receipt number | R000061102 |
| Scientific Title | Study to evaluate the safety and efficacy of stem cell culture supernatant (stem cell secretome) nasal drip therapy. |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/07/05 10:45:52 |
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Basic information
Public title
Study to evaluate the safety and efficacy of stem cell culture supernatant (stem cell secretome) nasal drip therapy.
Acronym
Study to evaluate the safety and efficacy of stem cell culture supernatant (stem cell secretome) nasal drip therapy.
Scientific Title
Study to evaluate the safety and efficacy of stem cell culture supernatant (stem cell secretome) nasal drip therapy.
Scientific Title:Acronym
Study to evaluate the safety and efficacy of stem cell culture supernatant (stem cell secretome) nasal drip therapy.
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment (MCI), Alzheimer's disease (AD)
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the safety and efficacy of nasal spray treatment with purified concentrated stem cell secretome extract (PureHGF x 30 + EXO) (Nature Bionics, Inc.) for 8 weeks in 20 patients with Alzheimer's disease who scored 10-19 (normal borderline to moderate) on the Hasegawa questionnaire and who have been appropriately diagnosed for nasal stem cell culture supernatant treatment at participating medical institutions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure (systolic and diastolic)/pulse rate
Hematological examination
Blood biochemical tests
Physician interview/adverse event assessment
Key secondary outcomes
Hasegawa questionnaire,MCI screening tests
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[1]Patients diagnosed as appropriate for nasal stem cell culture supernatant therapy at participating institutions
[2]Persons with normal borderline to moderate Alzheimer's disease and the Hasegawa questionnaire score 10-19 (mild to moderate)
[3]Persons who have received a full explanation of the purpose and content of this study and have obtained written informed consent from the subject himself/herself and a surrogate. However, if the attending physician determines that the subject has no problem with the subject's ability to consent, the consent of the surrogate is not required. If the attending physician determines that there is a problem with the subject's own capacity to consent, the consent of the substitute consentor is required, and the consent of the subject himself/herself will be obtained, except in cases where it is difficult to obtain consent from the subject due to the progress of the disease condition.
[4]Persons who are able to undergo the examination on the designated examination date.
[5]Persons who are deemed appropriate to participate in this study by the principal investigator or collaborating physician.
Key exclusion criteria
[1]Patients suffering from dementia other than Alzheimer's disease (vascular dementia, Lewy body dementia, frontotemporal dementia, etc.).
[2]Patients diagnosed with Alzheimer's disease who have a disease (medical disease, neurological disease, etc.) that causes dementia-like symptoms prior to Alzheimer's disease.
[3]Patients with a significant neurological disease or severe mental disorder other than Alzheimer's disease.
[4]Patients who are currently participating in other human clinical trials or who have not yet completed 3 months of participation in other human clinical trials.
[5]Other patients who are judged by the principal investigator or cooperating investigator to be inappropriate as subjects for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morita |
Organization
Medical Corporation Natural Harmony
Division name
Natural Harmony Clinic Omotesando
Zip code
150-0001
Address
Jingumae Media Square Building 5F, 6-25-14 Jingumae, Shibuya-ku, Tokyo
TEL
03-3400-7200
ymorita707@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Morita |
Organization
Medical Corporation Natural Harmony
Division name
Natural Harmony Clinic Omotesando
Zip code
150-0001
Address
Jingumae Media Square Building 5F, 6-25-14 Jingumae, Shibuya-ku, Tokyo
TEL
03-3400-7200
Homepage URL
ymorita707@yahoo.co.jp
Sponsor or person
Institute
Natural Harmony Clinic Omotesando
Institute
Department
Personal name
Funding Source
Organization
Natural Harmony Clinic Omotesando
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinsankenkai
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Society of Glycative Stress Research
Address
6F,Nishishinjuku Mizuma Bldg,3-3-13 Nishishinjuku,Shinjuku-ku,Tokyo
Tel
03-6868-4364
rinri-glycativestress@antiaging-bank.com
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
医療法人新産健会（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 15 | 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
18
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An exploratory observational study to evaluate the safety and efficacy of nasal spray therapy using purified concentrated stem cell secretome extract (PureHGF x 30 + EXO) (Nature Bionics, Inc.) for 8 weeks in 20 patients with Alzheimer's disease who scored 10-19 (normal borderline to moderate) on the Hasegawa questionnaire and who were diagnosed as appropriate for nasal stem cell culture supernatant therapy at the participating medical institution.
Management information
Registered date
| 2024 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061102
