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Dressings comprising platelet lysate

a technology of platelet lysate and dressing, which is applied in the field of dressings, can solve the problems of high limb amputation rate in military personnel, inconvenient use of incendiary materials, and frequent contamination with soil or sewage, so as to improve antimicrobial activity, minimize fluid loss, and avoid bleeding.

Inactive Publication Date: 2019-05-09
ARTERIOCYTE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present patent is about various dressings made from a delivery vehicle and human platelet lysate (hPL) that can be used for protecting wounds and treating other applications. The dressings come in the form of bandages that can speed up wound healing, prevent infection, and minimize fluid loss. The bandage is designed to be resilient and can deliver human-derived growth factors and agents to prevent infection and blood loss. The dressings can also come in liquid, cream, gel, shampoo, foam, or aerosol form.

Problems solved by technology

For example, the use of improvised explosive devices (IEDs) has introduced medical challenges related to severe blast-induced injuries.
IEDs use incendiary materials and are frequently contaminated with soil or sewage due to their source materials and / or placement.
As a result, severe burns and lacerations with consequential infection are common.
The loss of tissue viability and high incidence of infection has contributed to elevated limb amputation rates in military personnel who survive IED-induced injuries.
Similar concerns arise in the treatment of diabetic foot ulcers, which is one of several complications of diabetes that markedly impairs quality of life, shortens lifespan, and constitutes an enormous societal economic burden.
Various estimates indicate that the cost of DFU treatment consumes 25 to 50% of the total cost of all diabetes treatment.
Unfortunately, 45% to 55% of these patients die within 5 years of the amputation.
Despite a clearer understanding of the causal factors leading to limb loss and an increasing consensus on the management of various aspects of diabetic foot care in recent years healing rates for DFUs remain frustratingly low.
Unfortunately, current treatments result in healing rates of approximately 25% after 12 weeks and 30% after 20 weeks.
Disappointingly, these interventions provide only moderate improvement over standard treatments (generally only 15-20%), are considerably more expensive, and are associated with significant safety concerns.
For example, becaplermin increased the risk of cancer mortality in patients.
Other interventions, including hyperbaric oxygen and negative pressure devices, have shown promise in promoting DFU healing, but have yet to be tested in large clinical trials.

Method used

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  • Dressings comprising platelet lysate
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  • Dressings comprising platelet lysate

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0089]A preliminary bandage prototype was prepared by incubating 35 mm diameter circular disks of kaolin-impregnated gauze in human platelet lysate for 4 minutes at room temperature. The soaked gauze was immediately lyophilized. The initial in vitro hemostatic properties of the samples were measured by thromboelastography. The initial growth factor release characteristics of the samples were quantified using enzyme-linked immunosorbent assay (ELISA) with platelet-derived growth factor-BB (PDGF-BB), a pro-survival and angiogenic growth factor. The size, shape and mechanical strength of the samples before and after impregnation with hPL were also monitored.

[0090]FIGS. 7A-7E show the results. In these tests, blood was used as the control and baseline. “QuickClot®” refers to kaolin-impregnated gauze, and BioBandage QC™ refers to gauze that is impregnated with both kaolin and hPL. As seen in FIG. 7A and FIG. 7B, the addition of hPL did not reduce hemostatic capability. The BioBandage QC™...

example 2

[0091]To verify that lyophilized hPL still maintained growth factor activity, a cell culture supplement study was performed for three important dermal wound healing cell types: human mesenchymal stromal cells (MSCs), normal human dermal fibroblasts (NHDF), and neonatal human epidermal keratinocytes (NHEK). An aliquot of PLUS™ hPL was divided in two. One half of the aliquot was lyophilized and resuspended in an equal volume of deionized water, while the other half was frozen and then thawed prior to use. Culture media for each cell type was supplemented with both forms of 5% hPL as well as 10% FBS (as baseline) and the cells were cultured for a single passage. Culture with either form of PLUS™ resulted in no difference in the doubling times for all three cell types, and trended towards faster doubling times compared with FBS. These results indicate that the growth promoting activity of PLUS™ hPL was unaffected by the lyophilization process.

[0092]Next, to evaluate the ability of the l...

example 3

[0093]Another bandage prototype was prepared by combining bovine collagen and hPL at 37° C. for one hour, pouring the solution into molds, freezing the solution, and finally lyophilizing it. By weight, the bandage was approximately 27% collagen (1% w / v collagen solution) and 73% hPL. The resultant bandage was shelf stable. FIG. 9 is a picture of the bandage after being saturated with 0.9% saline, and shows the bandage is flexible and conformable to the surface of a wound.

[0094]The bandage demonstrated initial biocompatibility, safety, and non-toxicity testing. The bandage passed the following ISO 10993 tests: (A) Agar Diffusion cytotoxicity Test (mouse fibroblast L929 culture); (B) Kligman Maximization / Sensitization Test (guinea pigs); (C) Acute Systemic Injection Test (mice); (D) 28 Day Sub-Acute Systemic Toxicity by Implantation (rats); (E) 2 Week Intramuscular Implantation Test (rabbits); and (F) 4 Week Intramuscular Implantation Test (rabbits).

[0095]The bandage also demonstrated...

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Abstract

A dressing comprises a delivery vehicle and platelet lysate. The dressing can also include an antimicrobial agent, a hemostatic agent, and a binder. It is contemplated that the dressing can be used for expediting hemostasis, improving antimicrobial activity, minimizing fluid loss, and accelerating wound healing when applied to a wound. The dressing would be useful in applications including military in-theater medical care and for conditions such as diabetic foot ulcers, as well as other applications.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of PCT Application Number PCT / US17 / 39918, filed Jun. 29, 2017, which claims priority to U.S. Provisional Patent Application Ser. No. 62 / 356,163, filed on Jun. 29, 2016, which is hereby fully incorporated by reference.BACKGROUND[0002]The present disclosure relates to dressings that can be used to simultaneously address complex trauma, namely blood loss, incidence of infection, prevention of wound progression, tissue preservation and restoration, revascularization, and wound healing. Such technology can be useful in military theatres, humanitarian assistance, disaster relief operations, and treatment of acute and chronic conditions affecting military and civilian populations. The dressings include human platelet lysate, and are useful for various applications and purposes.[0003]New products that address critical aspects of traumatic wound care and can be easily used and deployed in large numbers mu...

Claims

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Application Information

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IPC IPC(8): A61L15/40A61L15/44A61F13/00
CPCA61L15/40A61L15/44A61F13/00063A61L2300/404A61L2300/418A61L2400/04
Inventor RAUT, VIVEK PRABHAKARSAMBERG, MEGHAN ELIZABETHDAY, KOLBY LUKEBARNES, BRIAN ROYRATHBONE, CHRISTOPHER RONALDPATTERSON, PATRICKBROWN, DONALD JUDEBAKER, JUSTIN JEFFREY
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