Evaluation of a Commercial Lyopreserved Placental Membrane Containing Viable Cells in 10 Patients with a Range of Comorbidities and Wounds

Background: Previous experience using a cryopreserved placental membrane containing viable cells (vCPM) has shown positive outcomes in the management of various acute and chronic wounds. Recently, a novel lyophilization technique has allowed for ambient storage of viable tissues.

Purpose: Here we evaluated if a commercial lyopreserved placental membrane containing viable cells (vLPM) would improve efficiencies of the clinic by reducing visit time and improve outcomes with time to closure.

Methods: Ten subjects with 11 wounds and a range of comorbidities were chosen to receive weekly application of vLPM adjunct to standard of care. A variety of wound types, both acute and chronic, were included in this case series – 5 diabetic foot ulcers, 4 venous leg ulcers, 1 pressure ulcers, 1 infected hardware with osteomyelitis, and 1 squamous cell carcinoma excision wound. 

Results: The mean wound duration prior to first application of vLPM was 4.9 months with the mean wound size being 3.09 cm².  Seven of the 11 wounds (63.6%) achieved complete closure with a mean number of 6.5 applications.  The median time to closure was 46 days.  Two subjects were removed for copious drainage, 1 subject was not improving and changed to topical steroid, 1 subject was removed for non-compliance and surgical intervention of a diabetic midfoot Charcot. This wound, however, achieved a 90% area reduction after 14 weeks of treatment. Further, there were no adverse events attributed to the use of this product.    

Conclusions: These preliminary results demonstrate that vLPM may be used as a good alternative in the management of acute and chronic wounds of various etiologies. Additionally, clinic office visit time was reduced as a result of the added convenience of room temperature storage.