phase i trial of xeno-skin

Learn more about our first-in-human, Phase I clinical trial of Xeno-Skin at www.clinicaltrials.gov

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Burn

Education

Quick Facts:

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• Over 1.3 million fires occurred across the United States in 2018 resulting in more than 3,600 deaths, a 20% greater loss of life since 2009.

• Deaths increase significantly with burn size, or total body surface area (TBSA). In 2015, 78% of the burn population experienced burns below 10% TBSA; 14% between 11-20% TBSA; and the remaining 8% greater than 20% TBSA. Burns over 10% TBSA are typically treated at designated burn centers such as the Sumner Redstone Burn Center of the Massachusetts General Hospital in Boston.

• Mass casualty events and disasters such as New Zealand's White Island Volcano Tragedy in 2019 are marked by a period of mismatch (disproportion) between supply and demand. 

• Severe and extensive, deep-partial and full-thickness burns requiring hospitalization are ideally treated with Human Deceased Donor (HDD) allograft skin, which possesses many of the dieal properties of biologic dressings and plays a major role in the surgical management of extensive wounds when autologous (self) tissue may not be immediately available or is contra-indicated. Fresh allograft skin represents the gold standard for all biologic dressings emlpoyed for temporary wound closure based on a number of its distince properties compared to cryopreserved skin. 

• The use of fresh HDD allografts has become extremely limited in recent yeras, however, due to increased FDA regulations put in place to reduce risk of disease transmission. Disadvantages of HDD allograft include bacterial infection, viral disease transmission, and limited supply.

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Source: U.S. Fire Administration (FEMA); Total Burn Care; Barone 2015

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crispr

Education

Quick Facts:  

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• CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats, which are DNA sequences found in bacteria that were originally from bacterial viruses called bacteriophage. The CRISPR-associated enzymes (called Cas enzymes) use this bacteriophage DNA to constantly monitor all DNA sequences inside the cell. If the Cas enzymes find DNA that matches the CRISPR sequences (as would be the case for viral infections), it triggers an immune response that destroys the viral DNA and prevents the bacteria from being infected by bacteriophage.

• The CRISPR/Cas system is useful as a gene editing tool. Scientists can manipulate CRISPR/Cas to target specific DNA sequences, such as those that cause fatal genetic diseases, and cut the DNA at that specific target site. Scientists then use that cut to their advantage to have other proteins repair the DNA, putting in healthy DNA in place of the pathogenic DNA.

• Scientists had the tools to edit human genomes before the discovery of the CRISPR/Cas system. However, these tools were expensive and labor-intensive, and sometimes did not work for particular DNA sequences. Because the CRISPR/Cas system comes from bacteria, it is cheap and easy to produce the necessary proteins. Additionally, the CRISPR/Cas system can easily be targeted to any DNA sequence. Lastly, it seems to be fairly specific, meaning that it should only target the specific DNA sequence that scientists program it to target, and not accidentally target other DNA (these are called “off-target” effects). 

• Scientists can currently use CRISPR/Cas gene editing technology to cure genetic diseases at the embryo stage — the single fertilized cell that will eventually become a person — with limited efficiency. CRISPR/Cas technology can only cut the DNA; scientists have to rely on already existing proteins in the human cell to repair damaged or pathological DNA, or find another way to introduce engineered proteins that will fix the DNA. This means the technology will not be widely variable for some time.

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Source: Biophysical Society

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