Systemic Sclerosis Clinical Trial
Official title:
Regional Grafting of Autologous Adipose Tissue in the Treatment of Systemic Sclerosis Digital Ulcers: a Prospective Randomized Controlled Study
A randomized controlled trial will be performed to confirm preliminary uncontrolled data
indicating that regional adipose tissue grafting is effective in inducing digital ulcer
healing in patients with systemic sclerosis.
Systemic Sclerosis patients with digital ulcers will be randomized to be blindly treated with
adipose tissue implantation or a sham procedure. Adipose tissue grafting will consist of
injection at the base of the finger with digital ulcer of 0.5-1 ml of adipose tissue after
centrifugation of fat aspirate. Sharm procedure will consist of false liposuction and local
injection of saline solution.
The primary end-point will be to compare the cumulative prevalence of healed digital ulcers
in the two groups within the following 8 weeks.
Systemic sclerosis (SSc) is an autoimmune disease characterized by a multifactorial
pathological process where a central role is played by the progressive loss of the
microvascular bed, with the consequent fibrotic changes in the involved organs and tissues.
The most advanced stages of capillary loss may induce the formation of digital ulcers (DUs)
on the fingertips.The healing of DUs is often a lengthy process requiring accurate and
intensive topical and systemic treatment. Nevertheless, in a significant number of cases this
therapeutic approach is ineffective and distal necrosis with subsequent tissue loss or
phalangeal amputation may eventually occur.
In a recent open pilot study performed by Del Papa et al., it has been demonstrated that
autologous adipose tissue grafting (AT-G), which is known to contain both adipose-derived
stem cells and a stromal/vascular fraction, was effective in inducing prompt healing of long
lasting DUs localized in the fingertips of a small number of patients with SSc. The DU
healing was accompanied by the rapid disappearance of local ischemic pain and evidence of a
partial restoration of the capillary bed in the digits when assessed by nailfold
videocapillaroscopy (NVC).
With the purpose of confirming these preliminary results, the investigators have designed a
monocentric randomized controlled study. In accordance with the study protocol, patients with
a typical SSc-related DU on the fingertip will be randomized to undergo a regional AT-G with
autologous fat as active therapy or a 'sham' procedure (SP) - that simulates the active
treatment - as placebo treatment. All of the patients with SSc enrolled in both arms will be
blind regarding the treatment received. Furthermore, during the study period all of the
enrolled patients will receive the same systemic vasoactive and topical therapy.
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