Trials / Completed
CompletedNCT00616135
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
A Clinical Evaluation Of Adipose Derived Regenerative Cells In The Treatment Of Patients With BrEast Deformities Post Segmental Breast ResecTion (Lumpectomy) With Or Without Radiation ThErapy. A Phase IV Post Market Study.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 71 (estimated)
- Sponsor
- Cytori Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).
Conditions
- Breast Neoplasms
- Carcinoma, Ductal, Breast
- Mammaplasty
- Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ADRC-Enhanced Autologous Fat Transplant | Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy. |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2008-02-15
- Last updated
- 2011-05-17
Locations
5 sites across 4 countries: Belgium, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00616135. Inclusion in this directory is not an endorsement.