Phages: Treatment on the horizon for spinal cord injury claimants?

29 Sep 2021

Phages: Treatment on the horizon for spinal cord injury claimants?

Provision of early rehabilitation in spinal cord injury (SCI) cases can often make a significant difference to future costs, allowing claimants to adapt to their condition and a return to social and economic activities as soon as possible. 

However,  initial hospital admissions tend to be longer in spinal cord injury patients and subsequent rehabilitation is often lengthy requiring more hospital admissions than in non SCI injuries.

Infection risk associated with SCI

Hospital acquired infections such as respiratory, urinary tract, and skin and bone related infections are the leading cause of death in SCI patients following the first anniversary of the injury.

Another area of concern for SCI patients are pressure sores, often aggravated by superinfections potentially causing osteomyelitis.

Risks of such infections mean that SCI patients have an increased risk of death and reduced life expectancy or a risk of further reduction in quality of life leading to an increase in future care and treatment costs.

Multi-drug resistant (MDR) microbes, often hospital acquired are a frequent concern.  Current treatments, which includes antibiotics, are often ineffective meaning such infections can have a significant impact on quality of life and future costs for treatments and care. 

The use of phages to treat bacterial infections may in the future help to reduce these risks. 

What are phages?

Bacteriophages, otherwise known as phages, are viruses that infect and kill bacteria, leaving human cells unharmed. They are highly specific to the bacterial species and strain.  They were discovered many years before antibiotics and used to treat infections.  However, upon the development of antibiotics, the use of phage therapy was considered too specific and complicated and in most countries their use was discontinued.

Phage therapy  is currently used in countries such as Georgia, Ukraine and Russia but have not been tested in clinical trials or within the standard European or American regulatory frameworks. 

Why are they important now?

In the modern world there are increasing concerns of antimicrobial resistance and the use of phages against bacterial infections is gaining ground.

Of particular interest in SCI patients would be the use of phage therapy for urinary tract, respiratory  and bone infections. 

Further studies / trials

At the moment the use of phage therapy is not authorised outside clinical studies in most countries although has occasionally been used in emergency cases. 

Phages are highly specific to the bacterial species and strain and use of them as antimicrobials requires isolation and study of how to use and target specific infections. 

Studies have taken place in relation to their use in UTIs and a controlled trial in the population using self-catheterisation is due to commence shortly using phages specifically targeted to treat catheter associated UTI.

Clinical trials are also starting for treatment of respiratory tract infections in cystic fibrosis patients. 

Phages may also be used to treat osteomyelitis and peri prosthetic joint infection.  Case reports have involved surgical procedures applying the phage directly to the site of infection and debridement of the infection site or prosthesis exchange, although more recently there are reports of intravenous application. 

The future

Clinical trial data is still clearly needed for phage therapy to become mainstream.  In the States, the Food and Drug Administration have granted orphan drug designation of phage therapy for treatment of osteomyelitis and peri prosthetic joint infection indicating that trials are soon to follow. 

There appears to be renewed engagement from the pharmaceutical industry and from within clinical and academic circles which offer some encouraging potential for future infection treatments.  This will be of particular interest for those at high risk of infections associated with spinal cord injury.

Of course the risks of infection in SCI claimants is one factor taken into account when considering post-injury life expectancy and hence the multiplier to be adopted when calculating damages. Reduction or better management of the infection risk might therefore increase damages if the impact of the risk of infection is reduced. Monitoring improvements in this area will be important not only in achieving the best outcome for the claimant but also in validating claims that such risks have been reduced.

Liz Hayward is an Associate (Fcilex) in the Spinal Injury Subject Matter Group at BLM.  The team will continue to provide updates on the many medical advances associated with SCI as they arise.

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Disclaimer: This document does not present a complete or comprehensive statement of the law, nor does it constitute legal advice. It is intended only to highlight issues that may be of interest to clients of BLM. Specialist legal advice should always be sought in any particular case.

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