Wound treatment gel obtainable by combining platelet rich plasma with autologously derived thrombin

A platelet-rich plasma and thrombin technology, which can be used in liquid delivery, drug combination, blood/immune system cells, etc., and can solve the problems of unapproved use and spread of bovine thrombin

Pending Publication Date: 2021-09-21
BIOTHERAPY SERVICES LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Other similar wound care gels have been produced, but they use bovine thrombin, which can lead to complications such as immune responses and the spread of infections such as bovine spongiform encephalopathy
Additionally, bovine thrombin is not approved for use in countries such as the UK

Method used

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  • Wound treatment gel obtainable by combining platelet rich plasma with autologously derived thrombin
  • Wound treatment gel obtainable by combining platelet rich plasma with autologously derived thrombin
  • Wound treatment gel obtainable by combining platelet rich plasma with autologously derived thrombin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] The following examples outline steps to be taken in the treatment of wounds, for example in diabetic patients.

[0082] stage 1

[0083] PRP with a hematocrit level of 8% was produced for the first treatment. The wound is "surgically refreshed" using surgical debridement of necrotic tissue to expose a fresh floor of the acute wound. The wound treatment composition was produced according to the following formulation. The formulation was designed for volume adjustment and the volume was doubled to treat over >7000mm 3 trauma.

[0084] i. 5ml PRP processed from 52mL whole blood. The PRP contains 5-6x the platelet concentration present in the whole blood sample

[0085] ii. Add 0.75mL ascorbic acid 500mg / 5ml USP

[0086] iii. Add 2 mL of autologous thrombin to activate the PRP / ascorbic acid fluid into a gel.

[0087] The first treatment contains concentrated platelets and a large "dose" of white blood cells. This phase may be referred to as hyperstimulation therap...

Embodiment 2

[0096] In a clinical setting, 18 wounds in 15 patients were treated. 5 patients had extensive tissue loss, bone / tendon / cartilage exposure; 3 patients had renal replacement therapy; 4 patients had significant peripheral neuropathy; 4 patients had deep osteomyelitis; severe nutritional deficiency. Average wound volume at start of treatment: 8203.3mm 3 (The range is 141.3-41257.2mm 3 ). Wounds were treated using the methods outlined in Example 1. Average wound volume at completion of PRP treatment: 2783.2mm 3 (The range is 0.5-28809mm 3 ). Mean reduction in wound volume at completion of treatment: 75%. Total days after initiation of PRP treatment until >90% wound healing: 17.9 days (range 6-40 days). One patient required post-treatment surgical intervention, which was referred to major amputation; the remaining patients were discharged without further intervention.

[0097] Figure 4 Examples of patient wounds treated in this study are shown and Table 1 details the redu...

Embodiment 3

[0101] Diabetic patients undergo surgical debridement of trauma and removal of osteomyelitis in the heel area. The wound is then treated with the wound treatment composition of the present invention. Three treatments were performed within 14 days.

[0102]Bending volume decreased by 36581.2mm in said 14 days 3 (-90.7%). The volume change is -417.3mm 3 (-30.8%), indicating an increase in volume as the wound granulates and regenerates tissue to seal the wound. The reduction of wound area is -1051.1mm 2 (-25.8%). Images of wound healing during the treatment are shown in Figure 5 middle.

[0103] The wound treatment composition is produced according to the present invention. The table below demonstrates the effect of performing the conversion of prothrombin to thrombin at temperatures below 15°C on certain key features of wound care therapy.

[0104]

[0105] The platelet, neutrophil and leukocyte concentrations are expressed as multiples of starting levels.

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PUM

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Abstract

The present invention provides a method of making a wound treatment composition, wherein the method comprises; i) fractionating a whole blood sample into multiple samples including a platelet rich plasma (PRP) sample,a platelet poor plasma (PPP) sample and a erythrocyte sample, wherein the PRP sample has a haematocrit level of 1-10%, ii) processing a portion of the PPP and / or PRP sample to facilitate cleavage of autologous pro-thrombin present in the PPP and / or PRP to produce autologous thrombin, and iii) combining the PRP sample with a portion of the PPP sample and a portion of the thrombin produced in step (ii) to produce the wound treatment composition; wherein step ii) is performed at less than 15 DEG C. In preferred embodiments the PRP has a haematocrit level of 2% or 8%. Wound treatment compositions produced by the methods are also provided as are compositions for use in treating chronic and acute wounds.

Description

technical field [0001] The present invention relates to a method of making a wound treatment composition, wherein the treatment comprises platelet rich plasma. Background technique [0002] Trauma is usually caused by physical injury to the body and may also be caused by an infectious disease or underlying condition. Trauma is generally classified as chronic or acute. Chronic wounds do not go through the normal phases of wound healing and are often associated with conditions such as diabetes. Acute trauma is usually inflicted suddenly and heals at a predictable and expected rate through the normal phases of wound healing. [0003] In medical practice, the need to treat trauma quickly and effectively is of great importance. For example, chronic wounds that do not heal in diabetic patients are a significant source of mortality and morbidity, and if the wounds cannot be treated, limbs will often have to be amputated. With the increasing incidence of diabetes, there is a gro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61K35/18A61K9/06A61P17/02A61K35/16A61K31/375
CPCA61K35/19A61K35/16A61P17/02A61L26/0057A61L26/0047C08L89/00A61K35/17A61K38/4833A61L26/009C12N5/0644A61K38/36A61K31/341A61K35/20A61K31/375
Inventor 珍妮特·哈德菲尔德
Owner BIOTHERAPY SERVICES LTD
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