Table 3.
An outline of the main significant clinical trials found in the literature
| Reference | Conventional Therapy and Indications (I) | Regenerative Therapy | No. of patients (no) Age (y, years) | Follow‐up (months) | Results (Phase 1) | Results (Phase II) | Complications (operative and in the follow‐up period) | Evaluation methods of the results |
|---|---|---|---|---|---|---|---|---|
| (Domenis et al., 2015) | ‐Autologous fat grafting (A), breast reconstruction, breast tissue contour correctionI: Breast augmentation | e‐SVF (Enriched Stromal Vascular Fraction) fat grafting (B) |
no.36:16 (A, control group)20 (B, experimental group) y. 21–71 (A)19–74 (B) |
12 | Long‐term augmentation effectDose: ≃106 cells per milliliter of harvested fat tissue | Thicker fat layer around the mammary gland | None | Ultrasonography imaging |
| (Dos Anjos, Matas‐Palau, Mercader, Katz, & Llull, 2015) |
‐Autologous fat grafting ‐Breast reconstruction, breast volume restoration I: Breast augmentation, breast cancer stage I to III |
e‐SVF fat grafting | no.77 fat grafting:21 (control group, low dose of SVF), 56 (experimental group,high dose of SVF) y. 18–61 | 18 | 75% and 50% breast volume retention in high and low e‐SVF groups, respectively Dose: >2 × 105 cells per mL of harvested fat tissue (high e‐SVF group); <5 × 104 cells per milliliter of harvested fat tissue (low e‐SVF group) | Decrease in the early postsurgical breast edema; Improvement of long‐term volume retention | Mondor's diseasenine cases of subcutaneous benign lumps. 14 oil cysts; No intraoperative complications | Imaging 3‐D, 3‐D scanner, superimposed to measure difference. |
| (Gentile et al., 2012) |
‐Autologous fat grafting (A) ‐Breast reconstruction, correction of contour and volume defects I: Breast cancer stage I to III |
e‐SVF fat grafting (B), fat grafting with PRP (Platelet‐rich plasma) (C) | no.10 (A,C control group)n.13 (B,C experimentalgroups) y. 19–65 | 30 | No microcalcifications No local tumor recurrence Dose: 200 mL average fat grafting for each breast. 5 × 104 SVF per milliliter of harvested fat tissue (B); 0,.5 ml of PRP per milliliter of harvested fat tissue | More natural breast contour and softness; Higher augmentation effect; Minor volume loss | None | Team evaluation; Patient self‐evaluation |
| (Kamakura & Ito, 2011) |
‐Autologous fat grafting ‐Breast augmentation I: Breast augmentation |
Autologous adipose‐derived regenerative cells | no.20 Single‐Arm study. y. 21–52 | 12 | Enhanced augmentation effect Dose: 240 ml average fat grafting for each breast; 3.42 × 105 cells per gram of harvested fat tissue | Increase in the circumferential breast measurement (BRM) | Cyst formation in two patients | Volumetric measurements |
| (Pérez‐Cano et al., 2012) |
‐Breast conserving therapy (BCT) ‐Breast tissue contour correction I: Breast augmentation, breast cancer stage I to III |
ADSC | no.12 Single‐Arm study. y. 37–68 | 12 | Permanent augmentation effectNo local tumor recurrenceNo post‐operative complicationsDose: 140 ml average fat grafting for each breast; 2.95 × 105 ADRCs per milliliter of harvested fat tissue | Improvement in breast contour defects; More natural breast shape; Reduction in scar tethering | None | MRI imaging; Ultrasonography imaging; Likert Scale for the evaluation of breast defect and contour |
| (Yoshimura et al., 2010) |
‐Mastectomy ‐Breast reconstruction or augmentation I: Breast augmentation |
e‐SVF fat grafting | no.15 Single‐Arm study. y. 35–50 | 12 | No microcalcifications Minimal volume lossPreservation of the fat tissueDose: 264 ml average fat grafting for each breast; 9.7 ± 1.7 × 107 stromal vascular cells per liter of fat tissue | More natural breast softness; Symmetry; Thicker fat layer around the mammary gland | Slight post‐operative atrophy; Few cysts (<5 mm) | MRI imaging; Mammography; Photography; Videography; 3‐D imaging |
Note . The letter “I” in the first column indicates the case in which the proposed approaches are clinically eligible.
Abbreviations: ADRC, adipose‐derived regenerative cell; ADSCs, adipose‐derived stem cells; SVF, stromal vascular fraction.