Clinical trial NCT00616135: Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Carcinoma, Ductal, Breast
Mammaplasty
Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
Keywords: Breast
Stem Cell
Adipose Derived Stem Cells
Adipose Derived Regenerative Cells
ADRC
Reconstructive Breast Surgery
Breast Reconstruction
Cancer
Carcinoma
Autologous fat transplantation
Autologous fat
Cosmetic breast deformities
Functional breast deformity
Lumpectomy
Segmental mastectomy
Quadrantectomy
breast conservation therapy
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jules Bordet Institute of Cancer
city: Florence
country: Italy
facility: Università degli Studi di Firenze
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Scotland
Study officials:
References: