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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018576
Receipt No. R000021501
Scientific Title Study for establishing evaluation method of bone marrow MSC mobilizer KOI2 activity
Date of disclosure of the study information 2015/08/06
Last modified on 2015/08/06

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Basic information
Public title Study for establishing evaluation method of bone marrow MSC mobilizer KOI2 activity
Acronym KOI2 activity study in human
Scientific Title Study for establishing evaluation method of bone marrow MSC mobilizer KOI2 activity
Scientific Title:Acronym KOI2 activity study in human
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have demonstrated that necrotic tissue-derived HMGB1 (high mobility group box 1) mobilizes mesenchymal stem cells (MSCs) from bone marrow into the circulation and accelerates tissue regeneration by inducing accumulation of MSCs in the necrotic tissues. We further elucidated particular MSC mobilization domain in HMGB1, designated as KOI2. With these backgrounds, we are now preparing academia-based phase I clinical trial for evaluating safety and tolerability of KOI2 in healthy adult male volunteers. In this clinical trial, we could not plan to evaluate MSC mobilization activity of KOI2, since the limited number of the involved individuals in this trial seems not be enough to make statistically significant conclusion of the KOI2 activity according to our previous mouse studies, which required robust number of mice to obtain statistically significant difference of KOI2 activity due to individual difference of the timing of MSC appearance in the circulation. Under this situation, in this clinical study, we aim to establish methods for evaluating KOI2 activity in human individuals by searching MSC levels in the peripheral blood of 1ml additionally drawn at various time points after KOI2 administration in the phase I clinical trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Number of MSCs in peripheral blood
Key secondary outcomes Differential blood cell count

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group1:KOI2 0.15mg/kg or Placebo, single dose administration
Interventions/Control_2 Group2:KOI2 0.5mg/kg or Placebo, single dose administration
Interventions/Control_3 Group3:KOI2 1.5mg/kg or Placebo, single dose administration
Interventions/Control_4 Group4:KOI2 3.0mg/kg or Placebo, single dose administration
Interventions/Control_5 Group5:KOI2 (1.5mg/kg or 3.0mg/kg) or Placebo in multiple dose administration for 4 days
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria 1) Healthy Japanese male age >=20 years and<= 40 years old
"2) BMI (kg/m2) more than 18.0 and less than 25.0
BMI = weight [kg] / (height [m]) 2"
3) A subject who hans not been smoking form more than 1 year and can agree to stop smoking from the day before the first dosage adminiatraion through post administration clinical visits
4) A subject who agrees to not consume alcohol 24 hours before hospitalization till discharge and 24 hours prior to every post clinical visits
5) A subject who agrees to prevent pregnacy until 28 days post the last dosage administration
Key exclusion criteria 1) A subject who has liver, kidney, GI, respiratory, heart and a blood system disease
2) A subject who has a past histroy of drug dependency
3) A subject who is difficult for intravenous administration (including episodes of vagal reflex syncope)
4) A subject who has the past of clinically significant drug allergy symptom and allergy to vaccine (anaphylactic shock, severe food allergy, hives, recurrent dermatitis, drug hypersensitivity, allergy to protein preparation, vascular edema)
5) A subject who has clinically important abnormal laboratory data by a blood test or urine test at the time of screening
6) A subject who is HIV Ab, HBs Ag, or HCV Ab positive by screening examination

7) Screening or baseline Qtc is over 450 msec or QRS interval is over 120 msec by 12-lead electrocardiogram
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuto Tamai
Organization Osaka University Hospital
Division name Dermatology
Zip code
Address 2-15, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6210-8396
Email tamai@gts.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuto Tamai
Organization Osaka University Hospital
Division name Dermatology
Zip code
Address 2-15, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6210-8396
Homepage URL
Email tamai@gts.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪大学病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 06 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 Preinitiation
Date of protocol fixation
2015 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 06 Day
Last modified on
2015 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021501

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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