Farivar BS, Toursavadkohi S, Monahan TS, Sharma J, Ucuzian AA, Kundi R, Sarkar R, Lal BK, et al.
Journal of vascular surgery. Venous and lymphatic disorders. Date of publication 2019 Mar 1;volume 7(2):228-233.
1. J Vasc Surg Venous Lymphat Disord. 2019 Mar;7(2):228-233. doi:
10.1016/j.jvsv.2018.09.016. Epub 2019 Jan 6.
Prospective study of cryopreserved placental tissue wound matrix in the
management of chronic venous leg ulcers.
Farivar BS(1), Toursavadkohi S(2), Monahan TS(2), Sharma J(2), Ucuzian AA(2),
Kundi R(2), Sarkar R(2), Lal BK(3).
Author information:
(1)Division of Vascular Surgery, Department of Surgery, Cleveland Clinic,
Cleveland, Ohio.
(2)Division of Vascular Surgery, Department of Surgery, University of Maryland
School of Medicine and Baltimore Veterans Administration Medical Center,
Baltimore, Md.
(3)Division of Vascular Surgery, Department of Surgery, University of Maryland
School of Medicine and Baltimore Veterans Administration Medical Center,
Baltimore, Md. Electronic address: blal@som.umaryland.edu.
OBJECTIVE: Chronic venous leg ulcers (VLUs) affect up to 2% of the general
population, resulting in a significant socioeconomic burden. Placental tissue
that contains mesenchymal stem cells and active growth factors has been shown to
be beneficial in healing of chronic wounds. We compared the efficacy of a human
viable wound matrix (hVWM) of cryopreserved placental tissue for the treatment of
refractory VLUs with standard therapy.
METHODS: This prospective single-center open-label single-arm study enrolled
patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C6
VLUs. The ulcers of all enrolled patients had failed to heal after a trial of
standard therapy of at least 12 weeks, which included weekly multilayer
compression therapy along with local wound care. The same patients subsequently
received application of hVWM (Grafix; Osiris Therapeutics, Columbia, Md) every 1
to 2 weeks in addition to standard therapy. Healing with hVWM therapy was then
compared with standard therapy, with each patient serving as his own control.
RESULTS: There were 30 VLUs in 21 consecutive eligible patients who were enrolled
in the study. All patients were men with an average age of 67 years (standard
deviation [SD], ±10.8 years), and the average area of venous ulcers before hVWM
initiation was 12.2 cm2 (SD, ±14.6 cm2; range, 3.3-12.3 cm2). Duplex ultrasound
confirmed superficial or deep system venous reflux in all patients. Complete
ulcer healing was achieved in 53% (16/30) of VLUs refractory to standard therapy
after application of hVWM. There was a mean reduction in wound surface area by
79% (SD, ±27.3%; P < .001 compared with standard therapy) after a mean treatment
time of 10.9 weeks. Eighty percent of VLUs were reduced in size by half compared
with 25% with standard therapy (P < .001). The mean rate of reduction in ulcer
area after hVWM applications was 1.69% per day vs 0.73% per day with standard
therapy (P = .01).
CONCLUSIONS: Cryopreserved placental tissue (hVWM) improves healing processes to
achieve complete wound closure in a significant proportion of chronic VLUs
refractory to standard therapy. Adjunctive therapy with hVWM provides superior
healing rates in refractory VLUs.
Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All
rights reserved.
DOI: 10.1016/j.jvsv.2018.09.016
PMID: 30621916
