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

Primary Purpose

Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ADRC-Enhanced Autologous Fat Transplant
Sponsored by
Cytori Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Jules Bordet Institute of Cancer
  • Università degli Studi di Firenze
  • Hospital General Universitario Gregorio Marañon
  • Instituto Valenciano Oncologia
  • Glasgow Royal Infirmary

Outcomes

Primary Outcome Measures

Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.

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.

Full Information

First Posted
February 5, 2008
Last Updated
May 13, 2011
Sponsor
Cytori Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00616135
Brief Title
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cytori Therapeutics

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
ADRC-Enhanced Autologous Fat Transplant
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Jules Bordet Institute of Cancer
City
Brussels
Country
Belgium
Facility Name
Università degli Studi di Firenze
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Instituto Valenciano Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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