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

This study has been completed.
Sponsor:
Information provided by:
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT00616135
First received: February 5, 2008
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cytori Therapeutics:

Primary Outcome Measures:
  • Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616135

Locations
Belgium
Jules Bordet Institute of Cancer
Brussels, Belgium
Italy
Università degli Studi di Firenze
Florence, Italy, 50134
Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Instituto Valenciano Oncologia
Valencia, Spain, 46009
United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
Cytori Therapeutics
  More Information

No publications provided

Responsible Party: Sean Gemmill, MS, RAC; Clinical Research Manager, Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT00616135     History of Changes
Other Study ID Numbers: RESTORE-2
Study First Received: February 5, 2008
Last Updated: May 13, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cytori Therapeutics:
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

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Neoplasms
Neoplasms
Carcinoma
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on May 23, 2013