Systemic Sclerosis Clinical Trial
Official title:
Lipograft Safety Enriched With Vascular Stromal Fraction Derived From Adipose Tissue, to Treatment of Digital Joint Fibrosis and Refractory Ischemic Digital Ulcers Caused by Systemic Sclerosis
Systemic sclerosis (SS) causes microvascular alteration in the hand and subsequently pain,
skin fibrosis, and osteoarticular deformities. These injuries initiate functional decline of
the hand and decrease patient quality of life.
Local application of adipose-derived stromal vascular fraction (ADSVF) has been proposed as
an emerging treatment. There are reports about the good results obtained after ADSVF
treatment in this kind of patients. For these reasons , we aimed to evaluate the safety and
clinical effect of application of fat micrografts enriched with ADSVF to the hands of
patients with SS.
The regenerative properties of adipose stem cells (ASCs) existing in the mixed cell fraction
obtained by enzymatic digestion of adipose tissue, termed adipose-derived stromal vascular
fraction (ADSVF), were initially described in 2002. These cells have the characteristics of
being multipotent and exerting local angiogenic, anti-inflammatory, antifibrotic,
immunomodulatory, and regenerative effects after application. ASCs express their angiogenic
properties most effectively in a hypoxic environment.
For the above reasons, and because of its abundance in fat, easy acquisition, and almost
immediate availability for use, ADSVF has positioned itself as an alternative for repair and
regeneration of ischemic tissue.
Application of decanted fat, centrifuged fat, and ADSVF, has consistently and significantly
improved pain, Raynaund Phenomen, and healing of digital ulcers in the hands of patients with
SS, and thus improved their quality of life. Other inconsistent benefits have also been
reported, such as decreased digital circumference, improvement in digital mobility and
strength, improvement in formation of new subungual capillaries, and improvement in function
through evaluation of the Cochin scale.
Based on the above findings, and because changes in the hands of patients with SS may arise
through loss of adipocytes and defective stem cell function, we designed the present study
with the aim of evaluating the safety, reproducibility, and clinical effects of application
of fat micrografts enriched with ADSVF to the hands of patients affected with SS in a
controlled clinical trial.
The experimental and control groups each contained 10 patients diagnosed with SS according to
the criteria of the American College of Rheumatology and the LeRoy-Medsger criteria.
It was decided to carry out the treatment on the most affected hand of the patients, which
was the right hand in the entire experimental group. ADSVF-enriched fat micrografts were
applied to the experimental group. Evolution and medical therapy effects were observed in the
control group.
The fat was obtained by liposucction and the ADSVF was processed in laboratory.
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