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. 2019 Nov 1;8(11):546-554.
doi: 10.1089/wound.2019.1028. Epub 2019 Oct 16.

Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Charles E Ananian  1 , R Daniel Davis  2 , Eric L Johnson  3 , Matthew J Regulski  4 , Alexander M Reyzelman  5 , Molly C Saunders  6 , Alla Danilkovitch  6
Affiliations

Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

Charles E Ananian et al. Adv Wound Care (New Rochelle). .

Abstract

Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable cells (vLPM) in the treatment of nonhealing wounds of various etiologies, and to compare them to those previously reported for cryopreserved placental membrane containing viable cells (vCPM). Approach: Patients with nonhealing wounds who qualified to receive advanced wound therapies were consecutively enrolled and treated weekly with vLPM plus standard of care (SOC) at five centers. Data were de-identified and retrospectively analyzed. Outcomes included closure, time to closure, number of vLPM applications, and adverse events (AEs). Results: Seventy-eight patients with 98 wounds (41 diabetic foot ulcers [DFUs], 19 venous leg ulcers [VLUs], 10 surgical, and 28 others) with an average size of 13.3 cm2 and 8.7 months duration were treated. Fifty-eight of the 98 wounds (59.2%) achieved complete closure with median time to closure of 63 days and 6 vLPM applications. The closure by wound etiology was 63% for DFUs, 47% for VLUs, 70% for surgical wounds, and 57% for other types of wounds. Similar closure rates have been previously demonstrated for vCPM. Wound duration was the main predictor of closure: 65.8% versus 30.0% (p = 0.004) closure was achieved for wounds of ≤12 and >12 months duration, respectively. There were no AEs related to vLPM application. Innovation: This is the first multicenter case series evaluating the clinical outcomes of vLPM in a real-world setting. Conclusion: These results support clinical equivalency between the two placental membrane formulations with the added convenience of room-temperature storage for vLPM, allowing it to be used in any wound-care setting.

Keywords: lyopreserved; nonhealing; placental membrane; viable; wound.

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Figures

None
Charles E. Ananian, DPM
<b>Figure 1.</b>
Figure 1.
A graphical representation of clinical outcomes with vLPM application plus SOC for (a) the proportion of patients who achieved complete wound closure, (b) time to closure, and (c) number of applications. SOC, standard of care; vLPM, lyopreserved placental membrane containing viable cells.
<b>Figure 2.</b>
Figure 2.
A graphical comparison of closure rates between (a) the current study with vLPM, a previous case series utilizing vLPM and previous studies utilizing vCPM in the treatment of wounds of various etiologies, (b) the current study and previous studies utilizing vCPM for chronic DFUs, and (c) the current study and a previous study utilizing vCPM for chronic VLUs. DFU, diabetic foot ulcer; vCPM, cryopreserved placental membrane containing viable cells; VLU, venous leg ulcer.
<b>Figure 3.</b>
Figure 3.
A graphical comparison of clinical outcomes between wounds ≤12 months duration and >12 months duration for (a) the proportion of patients who achieved complete wound closure, (b) time to closure, and (c) number of applications.
<b>Figure 4.</b>
Figure 4.
A graphical comparison of clinical outcomes between wounds ≤3.62 and >3.62 cm2 for (a) the proportion of patients who achieved complete wound closure, (b) time to closure, and (c) number of applications.
See this image and copyright information in PMC

References

    1. Sen CK, Gordillo GM, Roy S, et al. . Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen 2009;17:763–771 - PMC - PubMed
    1. Järbrink K, Ni G, Sönnergren H, et al. . The humanistic and economic burden of chronic wounds: a protocol for a systematic review. Syst Rev 2017;6:15. - PMC - PubMed
    1. Frykberg RG, Banks J. Challenges in the treatment of chronic wounds. Adv Wound Care (New Rochelle) 2015;4:560–582 - PMC - PubMed
    1. U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health. Guidance for industry: chronic cutaneous ulcer and burn wounds—developing products for treatment. 2006. June https://www.fda.gov/downloads/drugs/guidances/ucm071324.pdf (last accessed March27, 2019)
    1. Climov M, Bayer LR, Moscoso AV, et al. . The role of dermal matrices in treating inflammatory and diabetic wounds. Plast Reconstr Surg 2016;138(3Suppl):148S–157S - PubMed

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