Trials / Completed
CompletedNCT03776721
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Odense University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Liposuction | Liposuction is performed on the abdomen or thighs. |
| PROCEDURE | Fat graft | 30mL harvested lipoaspirate is injected at the affected axillary site. |
| PROCEDURE | Sham graf (Saline injection) | 30mL saline is injected at the affected axillary site. |
| BIOLOGICAL | Stem cell injection | 4mL stem cell suspension injected at the affected axillary site. |
| PROCEDURE | Saline injection | 4mL saline injected at the affected axillary site. |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2021-06-01
- Completion
- 2021-06-01
- First posted
- 2018-12-17
- Last updated
- 2021-06-25
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03776721. Inclusion in this directory is not an endorsement.