ADIPOSE-DERIVED STROMAL VASCULAR FRACTION AND FAT GRAFTS VERSUS MEDICAL TREATMENT FOR TREATING THE HANDS OF PATIENTS WITH SYSTEMIC SCLEROSIS. A RANDOMIZED CRONTOLLED TRIAL

Abstract

ABSTRACTBackgroundIn the hand, the Systemic Sclerosis (SS) is characteristically evidenced by Raynaud’s phenomenon (RP) and fibrosis of the skin, tendons, ligaments, and joints as well as digital ulcers with prolonged healing. Current medical treatment not always cure these complications. Local adipose-derived stromal vascular fraction (ADSVF) administration into the hands has been proposed as an emerging treatment for these complications, due to its proangiogenic, antifibrotic, and immunoregulatory activities. The objective of this controlled trial was to evaluate the safety and clinical effects of fat micrografts plus ADSVF administration into the hands of patients with SS.MethodsThis was an open-label, monocentric, randomized controlled study. Twenty patients diagnosed with SS were enrolled and assigned to the experimental or control group. Fat micrografts plus the ADSVF were injected into the right hand of experimental group patients. The control group continued to receive only medical treatment. Demographic, serologic data and disease severity were recorded. Digital oximetry, pain, Raynaud phenomenon (RP), digital ulcer healing (DUH), mobility, thumb opposition, vascular density of the nail bed, skin affection of the hand, Serologic antibodies, hand function, and quality of life scores were evaluated in both groups. The mean follow-up period was 168 days.The differences between before and after the intervention were analyzed with the Wilcoxon range test, and the differences between the control and experimental groups at 0 days and 168 days were analyzed with the Mann–Whitney U test.ResultsAdverse events were not observed in both groups. There were no changes in disease severity, serologic antibodies, nailfold capillaroscopy patterns, mobility, and hand function in both groups. There were significant improvements in pain, DUH and quality of life scores in the experimental group. RP improved significantly in both groups. However, on statistically comparing the results at 168 days between the groups, significant improvements were only observed in pain levels (p = 0.02) and DUH (p=0.003).ConclusionsThe injection of ADSVF plus fat micrografts is a reproducible, and safe technique. Pain and digital ulcers in the hands of patients with SS can be treated with this treatment.Trial RegistrationRetrospectively registered in ClinicalTrials.gov with identifier NCT04387825