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Adipose-Derived Regenerative Cell Transplantation in Systemic Sclerosis: Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells- a Randomized Clinical Trial.

OBJECTIVE
Hand dysfunction is common in systemic sclerosis (SSc). The objective of this study was to evaluate the capacity of autologous Adipose-Derived Regenerative Cells (ADRCs) to improve hand function in SSc patients.


METHODS
The STAR Trial was a prospective, randomized, double-blind trial of ADRCs injected into each finger digit of subjects with SSc. The primary endpoint was change in hand function at 24 and 48 weeks assessed using the Cochin Hand Function Scale (CHFS). Secondary endpoint included the change in Health Assessment Questionnaire-Disability Index (HAQ-DI) at 48 weeks. Separate analysis of subjects with diffuse (dcSSc) and limited cutaneous SSc (lcSSc) was pre-specified.


RESULTS
88 subjects were randomized to ADRCs (n=48; 32 dSSc:16 lcSSc) or Placebo (n=40; 19 dcSSc: 21 lcSSc). The primary end point was numerically higher for the ADRC group but did not achieve statistical significance (8.9±10.5 vs. 11.0±12.5, p= 0.299). For subjects with dcSSc the between group difference for the CHFS at 48 weeks was 6.3 points (nominal p=0.069). The HAQ-DI secondary endpoint exhibited a difference of 0.17 points (nominal p=0.044) for dcSSc group. 52% of ADRC-treated subjects with dcSSc reported improvement greater than the minimal clinically important difference for both CHFS and HAQ-DI compared with 16% in the placebo group (nominal p=0.016). Small volume adipose harvest and ADRC-treatment was well-tolerated.


CONCLUSION
While the primary end point of this trial was not achieved, efficacy trends were observed in subjects with dcSSc. Adipose harvest and ADRC injection were demonstrated to be feasible. Further clinical trial of this intervention in dcSSc is warranted.