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

NCT ID: NCT00616135

Last Updated: 2011-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-11-30

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).

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast; Mammaplasty; Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cytori Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Cytori Therapeutics

Locations

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

Countries

Belgium; Italy; Spain; United Kingdom

Other Identifiers

RESTORE-2

Identifier Type: -

Identifier Source: org_study_id