UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018576 |
|---|---|
| Receipt number | 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 23:30:42 |
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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
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
tamai@gts.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021501
