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

Sponsor

Cytori Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00616135

Collaborator

(none)

Enrollment

Locations

Duration (Months)

14.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Carcinoma, Ductal, Breast Mammaplasty Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,	Procedure: ADRC-Enhanced Autologous Fat Transplant	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

71 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Glasgow Royal Infirmary	Glasgow	Scotland	United Kingdom	G4 0SF