Background/Purpose: Adipose tissue-derived Stromal Vascular Fraction (ADSVF) has been proposed as regenerative treatment for hand deformities and digital ulcer healing in patients with Systemic Sclerosis (SSc). We aimed to evaluate its regenerative properties after local injection of autologous ADSVF in the hands of these patients.

Methods: This was an open-label, monocentric, randomized controlled study, approved by our local IRB and registered at clinicaltrials.gov (NCT04387825). Twenty patients diagnosed with SSc and moderate to severe hand contractures according to the Medsger’s severity scale and/or digital tip ischemic ulcers (distal to PIP joints) with more than 30 days of evolution despite medical treatment, were enrolled and assigned to the experimental or control group. Both groups continued standard medical treatment. Autologous ADSVF was obtained by liposuction and then by enzymatic digestion in the experimental group. This group received ADSVF plus fat micrografts injection into the right hand. Digital oximetry, pain, Raynaud phenomenon (RP), digital ulcer healing (DUH) time, range of motion (ROM), vascular density of the nail bed, cell surface markers, hand function, and quality of life scores were evaluated in both groups. The follow-up period was 168 days. Continuous variables were expressed as median with 95% confidence intervals. 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 and 168 days were analyzed with the Mann–Whitney U test. The range of total viable nucleated cells in the ADSVF was 167.5×10⁶ , with viability of 82% or higher. Stem cell markers into the ADSVF were: CD34+ 4.72% , CD45+ 43.9%, CD44+ 36.3%, CD73+ 6.18 %, CD90+ 34.4 %, CD105+ 7.27%, HLA-DR 12.1%, Stromal cells 4.05%.

Results: At 168 days of follow-up there were significant improvements in pain level (p= 0.02) and DUH (p= 0.003) only in the experimental group. We also found increased active ROM of the MCP joints in the treated hand of the experimental group, while the non-treated hand MCP joint ROM decreased significantly. Raynaud phenomenon improved in both groups. There were no changes in disease activity or severity, nailfold capillaroscopy pattern, mobility or hand function between both treatment groups. One patient in the experimental group reported transient hand edema that solved within 7 days.

Conclusion: ADSVF local injection is safe and well tolerated in SSc patients. This therapeutic method may improve pain and time to digital ulcer healing in patients with severe joint contractures and refractory digital ulcers.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/adipose-tissue-derived-stromal-vascular-fraction-plus-fat-grafts-for-hand-therapy-in-patients-with-systemic-sclerosis-a-randomized-controlled-clinical-trial/