The efficiency of adipose-derived stromal vascular fraction (ADSVF), or cells isolated from fat tissue, to treat ischemia and skin fibrosis in the hands of systemic sclerosis (SSc) patients has been investigation in a small clinical trial. A new study reported on the 12-month follow-up of patients receiving this treatment and found promising results.
The study, “Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up”, was published in the journal Rheumatology and performed by Perrine Guillaume-Jugnot and colleagues at the Aix-Marseille University, France.
In ADSVF, cells are isolated from fat tissue that is cleared of debris, red blood cells, and dead cells. The cell isolation and re-injection procedure is quick and automated, and the mix contains stem cells of various kinds, including mesenchymal stem cell-like cells and cells destined to become blood vessel endothelium or different blood cells. This cellular soup has been shown to have reparative and immunomodulatory properties.
In an earlier clinical trial, the researchers explored the safety and feasibility of subcutaneous injections into the fingers of 12 patients with SSc suffering hand ischemia and skin fibrosis. The trial reported improved quality of life, reduced hand disability, pain, Raynaud’s phenomenon severity, digital ulcers, finger circumference and vascular suppression score when analyzed six months following injection.
This study is an updated report of the same 12 patients 12 months after injection, women with limited skin SSc and without any serious organ damage.
Researchers found no new adverse events, and further improvement at one year in all efficacy parameters compared to six months, except for pain. Hand pain remained lower than before treatment, but had increased slightly compared to the measurement six months earlier.
Furthermore, some investigated parameters that were not significantly different at six months showed statistically significant improvement at 12 months, indicating that the cell-based therapy may have a continuously progressive beneficial effect on skin fibrosis.
The team concluded that the results support the notion of ADSVF as a promising treatment for improving SSc patients’ hand function, but also advised that the results be confirmed in a larger, double-blind, randomized control trial.