Status:
COMPLETED
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
Lead Sponsor:
Cytori Therapeutics
Conditions:
Breast Neoplasms
Carcinoma, Ductal, Breast
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
Brief 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 segm...
Eligibility Criteria
Inclusion
- Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
- Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
- Clean surgical margins
- No prosthesis in breast(s) to undergo treatment
- Ability to undergo lipoaspiration
- Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
- No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
- Objective signs of mild breast damage post Breast Conservation Therapy
- Type I Cosmetic Sequelae Classification
- A minimum of 1 cm of soft tissue (e.g. breast or fat) is available between the skin and chest wall at the recipient site
- A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
- No continuous adhesion of skin to bone \>3 cm in diameter
- The volume and shape of the defect(s) must be conducive to correction during a single treatment session (maximum defect volume ≤150 mL in breast(s) to undergo treatment)
Exclusion
- History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
- History of connective, metabolic or atrophic skin disease
- History of keloid scarring
- Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
- Life expectancy ≤ 2 years
- Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment
- Presence of any other known malignancy
- Body Mass Index (BMI) \>30
- Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI \>5 compared to baseline
- Presence of contraindications to MRI
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00616135
Start Date
June 1 2008
End Date
November 1 2010
Last Update
May 17 2011
Active Locations (5)
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1
Jules Bordet Institute of Cancer
Brussels, Belgium
2
Università degli Studi di Firenze
Florence, Italy, 50134
3
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
4
Instituto Valenciano Oncologia
Valencia, Spain, 46009