Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study )
- Conditions
- Epidermolysis bullosa
- Registration Number
- JPRN-UMIN000018252
- Lead Sponsor
- Osaka University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 48
Not provided
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( eanaphylactic 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 8) Screening or baseline BP is over 140/90 mmHg or below 100/50, or HR is out of the range of 40-100 after 5 minutes rest 9) A subject who has fever(body temperature over 37 degrees Celsius) 10) A subject who participated in other clinical trials within four months and received a clinical trial drug (including a placebo) 11) A subject using prescribed drug and/or Over-The-Counter drugs within 14 days 12) The person who lost more than 400 mL blood within 12 weeks or 200 ml blood within 4 weeks(by blood donation, etc.) 13) Ineligible by other reasons judged by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety(Adverse events, medical examination, 12-lead electrocardiogram, vital signs and laboratory data)
- Secondary Outcome Measures
Name Time Method