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Isolation, Cryopreservation and Culture of Human Amnion Epithelial Cells for Clinical Applications
Published on: December 21, 2014
Clinical experience using a dehydrated amnion/chorion membrane construct for the management of wounds
Joseph Caporusso1, Raymond Abdo2, Jeffrey Karr3
1Futuro Clinical Trials LLC, McAllen, TX.
Introduction:
Over time, acute and chronic, nonhealing wounds impose heavy financial and quality-of-life burdens on patients. The introduction of new therapies for wounds is essential in benefiting the patient, and in this report, the clinical experience of various wound care providers treating wounds with dehydrated amnion/chorion membrane (dACM) is presented.
Objective:
This retrospective clinical experience evaluated the effects of dACM in the treatment of 50 acute and chronic wounds of various etiologies.
Materials And Methods:
Retrospective case data of patients who received dACM as part of the course of treatment for a variety of acute and chronic wounds were obtained from 15 wound care institutions. The case data, consisting of patient history, previous wound care treatments, wound types and sizes, dACM applications and adjunctive treatments, and wound outcomes following dACM applications, were analyzed.
Results:
The mean (standard deviation [SD]) baseline wound areas were recorded for all wounds (N = 50; 11.251 cm2, SD = 15.575), venous leg ulcers (VLUs; n = 14; 18.756 cm2, SD = 20.848), diabetic foot ulcers (DFUs; n = 24; 10.387 cm2, SD = 14.432), and other wounds (n = 12; 4.225 cm2, SD = 2.074), respectively. With a mean of 5.9 (SD = 2.94) dACM applications per wound, 28 of 50 wounds (56%) achieved complete wound closure by the last observation. Of the ones that did not completely close, 9 (18%) had > 90% wound closure, and 8 (16%) had wound closure percentages ranging from 60% to 90% by the last observation. Of the total number of wounds, 45 (90%) had wound closure percentages between 60% to 100%. The median time to complete wound closure (or healing) for all wounds was 102 days (14.57 weeks), and the percent healing rates of all wounds healed at 16 and 24 weeks was 56% and 73%, respectively. For DFUs treated with dACM, the median time to healing was 120 days (17.14 weeks) and the percent healing rates at 16 and 24 weeks were 43% and 59%, respectively. For VLUs treated with dACM, the median time to healing was 90 days (12.86 weeks), with percent healing rates of 56% and 85% at 16 and 24 weeks, respectively. For all other wounds treated with dACM (including pressure ulcers, nonhealing surgical, ischemic, mixed etiology, and nonhealing amputation), the median time to healing was 48 days (6.86 weeks), with percent healing rates of 57% and 100% at 16 and 24 weeks, respectively.
Conclusions:
This retrospective case compilation of clinical experiences in patients with various acute and chronic wounds demonstrates that dACM may be beneficial in the treatment of wounds.
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