Cymetra: A Treatment Option for Refractory Ulcers

Author(s): 
Daniel Levy, MD;1 Meggan R. Banta, MD;1 Carlos A. Charles, MD;1 William H. Eaglstein, MD;2 Robert S. Kirsner, MD, PhD1

Nine of the 13 patients’ ulcers healed after Cymetra treatment. In eight of the nine patients, the ulcers remained healed for at least three months; the ulcer in patient 11 with peristomal PG reopened after six months and was successfully retreated with conservative wound care. The mean time to healing in the nine patients successfully treated with Cymetra was 3.7 months. Four patients’ ulcers failed to heal. The etiologies of the four nonhealing ulcers were pressure (2), eosinophilic fasciitis (1), and a stump ulcer (1). No adverse effects of Cymetra treatments were observed or reported.

Discussion

Chronic wounds affect more than 6.5 million patients each year and cause significant morbidity and impaired quality of life.6 Diabetes, venous or arterial insufficiency, and chronic pressure are the most common etiologies of poorly healing wounds in the US. Approximately 10 percent of leg ulcers are due to atypical causes including inflammatory conditions, such as PG, which can cause refractory ulcers.7
During the past decade, biologically active wound interventions, such as therapeutic growth factor proteins and tissue-engineered products, have become available. In 1997, recombinant human platelet-derived growth factor-BB (rhPDGF-BB, becaplermin) became the first therapeutic growth factor to receive FDA approval for healing chronic wounds.8 Similarly, tissue-engineered products, such as Apligraf® (Organogenesis, Canton, Massachusetts) and Dermagraft (Smith & Nephew, Largo, Florida), have been shown to stimulate healing, presumably through the production of growth factors in the wound bed and by providing a framework for the ingrowth of cells.9
Cymetra is a micronized form of AlloDerm, an allogeneic acellular dermal matrix. AlloDerm provides a three-dimensional collagen scaffold that is likely to promote cellular migration and tissue integration. Over time, this matrix is repopulated, and fibroblast infiltration has been confirmed by histology within one month.10 Moreover, its biologic nature provides AlloDerm less inclination toward infection, erosion, and rejection when compared with synthetic tissue replacement materials. In addition to serving as a filler for cosmetic use, there are recent reports suggesting the utility of AlloDerm to repair meningomyeloceles during neurosurgical reconstructions, increase gingival thickness in patients with buccal recession defects, and repair abdominal wall hernias.11–13
Cymetra is the first available injectable dermal matrix. Cymetra maintains the ultrastructure of the dermis yet easily passes through an 18-gauge needle. These properties lend Cymetra significant advantages in ulcers that are deep or undermined and in sinus tracts. As a promoter of healing in recalcitrant sinus tracts, Cymetra has been recently reported in two patients, one of which had a sinus tract complicated by PG. Clinical studies to date describe no allergic or immunologic reactions to Cymetra.
In this article, the authors report the success of Cymetra in the treatment of chronic wounds. The authors treated 13 patients suffering from chronic ulcers with injections of Cymetra. The ulcers in nine of the 13 patients (69%) healed. These results are similar to those reported by Embil, et al., with the off-label use of becaplermin in which 57.5 percent of patients achieved complete healing of lower-extremity ulcers and also similar to the report by Harrison-Balestra, et al., in which 64 percent of ulcers healed with becaplermin.14,15 Although Patient 2 failed to heal, the wound showed a marked increase in granulation tissue and was prepared for the placement of V.A.C.® Therapy™ (KCI Inc., San Antonio, Texas). Similarly, there was an increase in granulation tissue in the stump ulcer of Patient 5, and she subsequently underwent a split-thickness skin graft.

References: 

References

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