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Phase 1 / 2 clinical study of patients seeking breast augmentation using autologous peripheral blood mononuclear cell ex vivo culture amplified cells (MNC-QQ)

Phase 1 / 2 clinical study of patients seeking breast augmentation using autologous peripheral blood mononuclear cell ex vivo culture amplified cells (MNC-QQ) - Phase 1 / 2 clinical study of patients seeking breast augmentation using MNC-QQ

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb030230627
Enrollment
5
Registered
2024-02-13
Start date
2024-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients seeking breast enlargement. Breast enlargement

Interventions

Peripheral blood sampling as raw material for the preparation of specific cellular products (MNC-QQ cells) and blood sampling for various tests. Liposuction is performed from the thigh or abdomen. The

Sponsors

Ikeda Yoshio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Safety of MNC-QQ-added fat grafting Side effects, adverse events, serious adverse events

Secondary

MeasureTime frame
Efficacy (maintenance rate, appearance) Weight change Patient satisfaction

Countries

Japan

Contacts

Public ContactTaro Aikawa

Houjukai medical corporation Tokyo Skin/Plastic Surgery clinic Ginza

aikawa@ginzaikeda.com+81-3-3545-8000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026