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TOPIC: German meta-study highly critical on RESTORE-II

German meta-study highly critical on RESTORE-II 05 May 2015 07:15 #4409

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German scientists did a meta study whether claims by the cosmetic industry in respect of cell-assisted lipotransfer were supported by scientific and clinical evidence.

Clearly it is not, since most data is not based on real studies. Only 3 studies were specifically reported upon, since they fulfilled the criteria of a scientific study- one of them being RESTORE -II, however they were very critical on the methods and conclusions. :whistle:

RESTORE-2 was a one-armed, prospective, multicenter trial carried out in 2012 on 71 women with breast contour defects after breast-conserving treatment for cancer (11). Its defined primary endpoints were patient satisfaction and physician satisfaction with the functional and cosmetic outcomes of cell-assisted lipotransfer, and improvement of the pre-procedural breast deformity 12 months after the procedure. Notably, the authors had originally intended to analyze the results by MRI volumetry but could not do so, because a volume defect was demonstrable before lipotransfer in only 51 of the patients. They therefore introduced a subjective scar rating scale while the trial was in progress. This scale also ”did not adequately reflect the clinical improvements,” yet the authors reported that they had found a statistically significant improvement, without any further explanation of this statement. The patients’ quality of life during treatment was reported to be “stable,” and 45 of the 67 patients rated their satisfaction from 4 to 6 on a six-point scale, i.e., no explicit dissatisfaction was mentioned. A far more worrisome flaw of this trial was the fact that oncological safety was not addressed at all, let alone defined as an outcome parameter.

Having followed their patients up for only one year, the authors concluded that “RESTORE-2 has sufficiently demonstrated the safety and efficacy of ADRC-enriched fat grafting in the treatment of soft tissue defects post-BCT” and “this procedure should be considered as an alternative reconstructive option for women with post-BCT defects.” Considering that one patient developed a distant osseous metastasis during follow-up, it seems premature at best to draw this conclusion from the RESTORE-2 trial, which was financed by the manufacturer of the device used in it (29).

In contrast, the trial of Tanikawa et al. (26) shows that high-quality research in this field is, in fact, possible. It is one of only two trials in which cell-assisted lipotransfer was studied with appropriate methodological prudence. This prospective, randomized, controlled, double-blind trial compared cell-assisted and conventional lipotransfer for the treatment of facial soft-tissue defects due to craniofacial microsomia. Despite certain limitations, including a high dropout rate and the small volumes of tissue transplanted in comparison to the amounts that are commonly transplanted in cell-assisted lipotransfer, the authors were able to show that the technique yielded better volume consistency than conventional lipotransfer for this special indication.


Well- is not the only problem, which was self-inflicted by Cytori management. :evil:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

German meta-study highly critical on RESTORE-II 05 May 2015 07:19 #4410

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I attach the complete original study published in the "Deutsche Ärzteblatt"...



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File Name: 2015-Cell-assistedLipotransfer.pdf
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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