Platelet lysate gel

Abstract

The invention concerns a pharmaceutical composition comprising a platelet lysate and its use to treat a wound, an anal fissure, vaginal atrophy or a wrinkle.

Description

FIELD OF THE INVENTION[0001]The invention concerns a pharmaceutical composition comprising a platelet lysate and its use to treat a wound, an anal fissure, vaginal atrophy or a wrinkle.BACKGROUND OF THE INVENTION[0002]Approximately 15% diabetics will have an ulcer in their lifetime. Annual, population-based incidence of 1% to 3.6% among people with type 1 or type 2 diabetes. By 2030, approximately 13 million people will suffer a diabetic foot ulcer each year. Foot ulcers precede more than 84% of non-traumatic lower limb amputations. In addition, the 3-year mortality after a first amputation has been estimated as high as 20-50%. The average cost of healing a single ulcer is $8,000, that of an infected ulcer is $17,000, and that of a major amputation is $45,000. The excess cost attributed to foot ulcers and their sequelae averaged $27,987 per patient for a 2-year period following ulcer presentation (American Diabetes Association; US Department of Health and Human Services; Diabetes Ca...

AI Technical Summary

Benefits of technology

[0044]The pharmaceutical composition of the invention or the platelet lysate of the invention will be easily adapted for the chronic wound healing markets and conveys the following advantages over platelet rich plasma and other autologous regenerative cell therapies.

Problems solved by technology

If untreated, a diabetic ulcer can progress from a small irritated but unbroken skin patch to a potentially life-threatening wound involving extensive tissue death and infection.

An advanced dressing such as hydrocolloid gel have limited improvement over traditional non-adherent gauze in the treatment of diabetic ulcers [6].

Technological breakthroughs in wound healing have also been limited over the last 15 years, with little improvement regarding patient quality-adjusted life year (QALY) outcomes [7].

Type I collagen undergoes natural breakdown by enzymatic degradation; however, this degradation in human skin is exceedingly slow [12].

This leads to further malfunctioning of the connective tissue cells in a feedback loop.

In aged human skin, attachments of fibroblasts to integrins are lost and fragmented collagen fibrils fail to provide sufficient mechanical stability to maintain normal mechanical tension.

Reduced collagen production and increased collagenase-catalysed collagen fragmentation result in further reduction of mechanical tension, thereby causing continual loss of collagen [1].

Importantly, these crosslinks are not able to be efficiently broken down and removed during the slow normal process of MMP-mediated turnover, causing accumulation of fragmented collagen within the extracellular matrix as skin ages [15, 16].

The fragments cannot be repaired or incorporated into newly made collagen fibrils, and therefore cause defects in the three dimensional collagen matrixes.

These defects impair the structural and mechanical integrity of the dermis and thereby deleteriously alter its function.

Current treatments on the market fail, they do not recreate youthful appearance with lasting results.

Toxins temporarily relax muscles in the face that stretch the skin, but does not repair the underlying extracellular matrix.

Botox® and Dysport® can result in ‘frozen face,’ with problems swallowing, speaking, and breathing.

Fillers (such as hyaluronic acid, collagen, poly-L-lactic acid, and hydroxylapatite) ‘fill the gaps’ for a short period, but does not restore skin to normal physiology or prevent the degenerative cycle.

Technological breakthroughs in cosmetics have been limited over the last 30 years, with sporadic advancements over the last decade.

There are several long standing issues affecting the wide spread adaptation and use of platelet lysate (PL) in the clinic.

The main issues have been, but are not limited to the following: donor derived samples run the risk of contamination during processing; platelet quality varies from patient to patient in terms of count and ability to secrete beneficial growth factors making the preparations inconsistent; there is a need for platelet quantitation in physician office kits; therapeutic preparation introduces high patient-by-patient variability affecting efficacy due to intrinsic differences in platelet count; current methods are inconvenient, clinicians must centrifuge blood to isolate platelets from blood, and the variability of this process, which can last between 25-30 minutes, again introduces errors; and the current processes are not cost-effective with an estimated cost of $130 per treatment (Plateltex).

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