Table 1b. Further studies found by the updating process.
| Study | Indications, design, and methods | Results and conclusions | Do the findings support the conclusion? | EL | Conflict of interest? |
|---|---|---|---|---|---|
| Tanikawa 2013 (26) |
Prospective, two-armed, randomized, blinded trial; CAL vs. AFT in 18 patients with craniofacial microsomia Method: CT volumetry Follow-up: Up to 12 months | Significantly better volume retention in the CAL group; 4 dropouts (2 per group); CAL is safe, effective, and superior to AFT | High methodological quality; sole study known to us showing an advantage for CAL for a special indication. Conclusion about safety not supported by findings. Limitations: low number of patients, high dropout rate, not generalizable to common indications | II–III | No financial conflict of inerest |
| Perez-Cano 2012 (11) |
Prospective, one-armed, multicenter trial: CAL in 71 women after breast-conserving treatmentMethods: Clinical examination, LENT-SOMA, assessment of pt. satisfaction on a 6-point scale, MRI Follow-up: Up to 12 Monate | 4 dropouts, repeat procedures in 24 pts., MRI abandoned for inadequate sensitivity; pts. and physicians generally satisfied; bone metastasis (1 pt.), cyst formation (10 pts.);CAL is safe and effective | Conclusion not at all supported by findings; marked methodological deficiencies | IV | Technical and financial support of the device manufacturer |
| Peltoniemi 2013 (27) |
Prospective, two-armed, non-randomized trial; 18 patients underwent CAL or AFT for breast augmentation Method: MRI volumetry Follow-up: Up to 6 months | No significant intergroup difference; one case of cyst formation in each group; trial terminated because of lack of advantage from CAL; AFT quicker, cheaper, and theoretically safer with at least equivalent outcomes | The conclusion is reasonable, although the trial groups were small | III | No conflict of interest |
AFT, autologous fat transfer; CAL, cell-assisted lipotransfer; EL, evidence level; LENT-SOMA, late effects on normal tissues, subjective/objective management analysis (interdisciplinary assessment of long-term oncologic treatment outcomes); MSC, mesenchymal stem cells; pt./pts., patient(s)