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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.


Phase 4
18 Years
75 Years
Not Enrolling
Female
Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

United Kingdom: Research Ethics Committee

Study ID:

RESTORE-2

NCT ID:

NCT00616135

Start Date:

June 2008

Completion Date:

November 2010

Related Keywords:

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

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