Clinical trial · Interventional
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
NCT01801878CI-TRIAL-00047872withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in recruiting research subjects
Summary
Brief summary (as posted)
The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Skin Abnormalities | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adipose SVF cell | Biological | — | UNRESOLVED |
| Normal saline | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adipose SVF cell
- description
- adipose SVF cell transfer to the half of irradiated breast
- interventionNames
- Biological: Adipose SVF cell
- type
- ACTIVE_COMPARATOR
- label
- Normal saline
- description
- Normal saline inject to the half of irradiated breast
- interventionNames
- Biological: Normal saline
Primary outcomes (1)
- measure
- The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
- timeFrame
- change in the breast skin thickness from baseline at 12 week
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Female aged between 40 and 60 * Subjects who diagnosed breast ductal carcinoma in situ of surgical staging T1aN0, negative resection margin of below 2mm in histopathologic examination * Subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy * Subjects who understand the study contents and sign the informed consent Exclusion Criteria: * Subjects who have radiodermatitis * Subjects who planned breast reconstruction with autogenous tissue (ex.Transverse Rectus Abdominis Muscle flap) * Subjects who have a history of smoking within 3months recently * Subjects who participated in other clinical trial within 30 days recently * Pregnant or lactating subjects * Subjects who have a active infectious disease * Subjects who are not eligible for this study at the discretion of the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.