An ulcer is a trophic lesion with loss of tissue that often has a multifactorial genesis.
It typically diverges from the physiologic processes of regeneration because it rarely
tends to heal spontaneously. In this study, we used purified adipose-derived stem
and regenerative cells (ADRCs) extracted from autologous fat, for the care of chronic
ulcers of the lower limbs of arteriopathic patients. The primary objective of this
study was complete re-epithelization of chronic ulcers; the secondary objective was
a decrease in diameter and depth.
From January 2010 to January 2012, 20 patients with peripheral arterial disease, with
an ankle-brachial index between 0.30–0.40, in the age range 60–70 y (14 men and six
women), with chronic ulcers of the lower limb, were involved in the study. Only 10 arteriopathic
patients (seven men and three women) with chronic ulcers of the lower limb were surgically
treated. Using the Celution system, we isolated a solution of ADRCs in about 150 min.
The isolated cells were injected through a 10-mL syringe into the edges of the ulcer,
taking care to spread it in all directions. Using a small amount of Celution extract,
we performed cell characterization by flow cytometry analysis and cell viability assay.
We monitored patients treated with ADRC or untreated at 4, 10, 20, 60, and 90 d. In
all cases treated with ADRC, we found a reduction in both diameter and depth of the
ulcer, which led to a decrease in pain associated with the ulcer process. In six of
10 cases there was complete healing of the ulcer. Characterization of the cells by
FACS clearly showed that the ADRC cells contained adipose-derived stem cells. Viability
assays demonstrated that partial or total closure of the ulcer was attributable exclusively
to ADRC cells present in the Celution extract, and not to growth factors extracted
during the process of purification of the Celution and injected together with the
For the first time, the Celution method has been applied for the care of chronic ulcers
in the lower extremity of patients with peripheral arterial disease. Our results demonstrate
that the technique is feasible for autologous cell application and is not associated
with adverse events. Moreover, the transplantation of autologous stem cells extracted
with Celution may represent a valuable method for the treatment of chronic ulcers
in lower limbs of arteriopathic patients.