Ananian CE, Davis RD, Johnson EL, Regulski MJ, Reyzelman AM, Saunders MC, Danilkovitch A, et al.
Advances in wound care. Date of publication 2019 Nov 1;volume 8(11):546-554.
1. Adv Wound Care (New Rochelle). 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.
Ananian CE(1), Davis RD(2), Johnson EL(3), Regulski MJ(4), Reyzelman AM(5),
Saunders MC(6), Danilkovitch A(6).
Author information:
(1)New Hope Podiatry, Los Angeles, California.
(2)Family Podiatry Center, Bridgeport, Connecticut.
(3)Bozeman Health Deaconess Hospital, Wound and Hyperbaric Center, Bozeman,
Montana.
(4)Ocean County Foot & Ankle Surgical Associates, P.C., Forked River, New
Jersey.
(5)California School of Podiatric Medicine at Samuel Merritt University,
Oakland, California.
(6)Osiris Therapeutics, Inc., Columbia, Maryland.
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.
© Charles E. Ananian, et al. 2019; Published by Mary Ann Liebert, Inc.
DOI: 10.1089/wound.2019.1028
PMCID: PMC6798798
PMID: 31637101
