Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy

Phase 4

Completed

• Conditions: Breast Neoplasms; Carcinoma, Ductal, Breast; Mammaplasty; Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,

• Registration Number: NCT00616135
• Lead Sponsor: Cytori Therapeutics

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 segmental mastectomy or quadrantectomy (lumpectomy).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-15
• Study Start: 2008-06
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.	12 months

Secondary Outcome Measures

Name	Time	Method
Change in breast volume and shape at 6 and 12 Months compared to baseline. Improvement in skin pigmentation abnormalities at 6 and 12 months compared to Baseline. Improvement in overall breast deformity at 6 Months compared to Baseline.	6 months and 12 months

Trial Locations

Locations (5)

Jules Bordet Institute of Cancer; 🇧🇪 Brussels, Belgium

Università degli Studi di Firenze; 🇮🇹 Florence, Italy

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Instituto Valenciano Oncologia; 🇪🇸 Valencia, Spain

Glasgow Royal Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom