Clinical trial · Interventional
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
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.
NCT00616135CI-TRIAL-00004850RESTORE-2completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Ductal, Breast | Breast Ductal Carcinoma | ALIAS | 0.90 |
| Mammaplasty | — | UNRESOLVED | — |
| Mastectomy, Segmental, Lumpectomy, Breast Reconstruction, | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADRC-Enhanced Autologous Fat Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- 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.
- timeFrame
- 6 months and 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.