RESTORE-2 Clinical Study – Complete
RESTORE-2 is a European clinical study. The official title is: A Clinical Evaluation Of Adipose Derived
R
egenerative Cells In The Treatment Of Patients With Br
E
ast Deformities Post
S
egmental Breast Resec
T
ion (Lumpectomy) With
O
r Without
R
adiation Th
E
rapy.
RESTORE-2 is a Phase IV post-market study evaluating the transplantation of autologous fat, augmented with Adipose-Derived Stem and Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy). RESTORE-2 is a prospective, open-label efficacy study in which all patients were treated with their own ADRCs and fat tissue.
The study was completed in 2010.
What is the Purpose of RESTORE-2?
RESTORE-2 was initiated to study cell-enriched reconstruction in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).
There are limited reconstructive options to address tissue defects and asymmetry which commonly result from segmental mastectomy or quadrantectomy (lumpectomy). Commercially available breast implants are not suitable nor intended to address post–breast conservation therapy (BCT) defects while other reconstructive options are highly invasive and associated with extended hospitalization and increased morbidity. Transplantation of autologous fat tissue has been tried with unpredictable clinical outcomes due to variable rates of transplant retention over time.
With the RESTORE-2 study, the hope is to discover that enriching a patient’s fat graft with her own ADRCs will improve graft survival as well as patient and physician satisfaction with the improvements to the breast deformity.
Data from RESTORE-2 will be used to further support market adoption and insurance reimbursement for the procedure.
Data from the investigator-initiated RESTORE I study were presented at the San Antonio Breast Cancer Symposium on December 15, 2007, Stem cell augmented reconstruction: A new hope for reconstruction after breast conservation therapy.
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This study evaluated 21 women who underwent Cell-Enriched Reconstruction after partial mastectomy and found the procedure to be safe, effective, and well tolerated. There was a statistically significant improvement in breast tissue thickness from baseline to one month post procedure with no significant loss in tissue thickness from one month to final follow-up. Furthermore, 79% of the patients were satisfied with the outcome.
>> Learn More about the RESTORE-2 Patient Profile
References
1. Kitamura K., et al. Stem cell augmented reconstruction: a new hope for reconstruction after breast conservation therapy. Breast Cancer Res Treat. 2007;106(Suppl 1): Abstract 4071.