Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy (RESTORE-2)

Cytori Therapeutics

Status and phase

Completed

Phase 4

Conditions

Carcinoma, Ductal, Breast

Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,

Mammaplasty

Breast Neoplasms

Treatments

Procedure: ADRC-Enhanced Autologous Fat Transplant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00616135

RESTORE-2

Details and patient eligibility

About

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).

Enrollment

71 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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