Phase 1 / 2 clinical study of patients seeking breast augmentation using autologous peripheral blood mononuclear cell ex vivo culture amplified cells (MNC-QQ)
- Conditions
- Patients seeking breast enlargement.Breast enlargement
- Registration Number
- JPRN-jRCTb030230627
- Lead Sponsor
- Ikeda Yoshio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
1. Patients with written informed consent.
2. Patients are at the age of 18 to 60 at the time of informed consent.
3. BMI 18-30 kg/m^2
4. Patients who can benefit from breast enlargement with 50-100 ml of fat grafting per side.
1. Patients with severe systemic infections.
2. Patients with severe anemia.
3. Patients with a history of diabetes mellitus.
4. Patients with a history of malignancy including breast cancer.
5. Patients receiving drugs that inhibit angiogenesis.
6. Patients with hematologic diseases such as hematologic tumors, myeloproliferative disorders, or myelodysplastic syndromes.
7. Patients known at the time of enrollment to have a third-degree relative with proven hereditary breast cancer such as hereditary breast-ovarian cancer syndrome.
8. Patients who have undergone any kind of breast augmentation within the past 6 months.
9. Pregnant or lactating women or patients who wish to become pregnant during the period of participation in this study.
10. Patients with HIV, active HBV, HCV, HTLV, or syphilis infection detected during the screening period.
11. Patients with an implanted pacemaker
12. Patients who are thought to have a life expectancy of 1 year or less due to complications
13. Patients who have participated in other clinical trials within 90 days prior to obtaining consent (except when the investigational drug was not administered)
14. Other patients who are judged by the principal investigator or subinvestigator to be inappropriate as subjects for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of MNC-QQ-added fat grafting<br><br><Safety evaluation criteria><br>Side effects, adverse events, serious adverse events
- Secondary Outcome Measures
Name Time Method Efficacy (maintenance rate, appearance)<br>Weight change<br>Patient satisfaction