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

Breast Neoplasms Clinical Trial

— RESTORE-2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616135
• Other study ID #: RESTORE-2
• Status: Completed
• Phase: Phase 4
• First received: February 5, 2008
• Last updated: May 13, 2011
• Start date: June 2008
• Est. completion date: November 2010

Study information

• Verified date: May 2011
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Congenital Abnormalities
• Mammaplasty
• Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Jules Bordet Institute of Cancer	Brussels
Italy	Università degli Studi di Firenze	Florence
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Instituto Valenciano Oncologia	Valencia
United Kingdom	Glasgow Royal Infirmary	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Countries where clinical trial is conducted

Belgium,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.		12 months	No
Secondary	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	No