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Initially, the developer intends to sell pork with supplies, not in supermarkets. PHOTO: Reuters
Ambitions are for the production of hypoallergenic heparins, for tissues and organs with a lower risk of rejection in transplantation
The United States Food and Drug Administration has approved a genetically modified GalSafe pig for food use and biomedical potential. The change in genes is intended to prevent your body from producing a single carbohydrate component:
alpha gal, what
provokes
allergies in humans
The authorized animals are called alpha-gal safe pigs (GalSafe pigs).
They are designed to provide meat that is safe for people with intolerance. And organs and tissues have the potential to be transplanted into people who are allergic to alpha-gal. The human reaction is a newly defined type of food allergy to red meat and other mammalian products.
Alpha-gal syndrome is usually caused by a tick bite. Then sugars unknown to our body enter the human body. In some people, they cause a reaction in the immune system.
“Alpha-gal safe pigs are the first animals to be approved both as a feed and as a potential source for therapeutic use. Licensing the biomedical product is a great step for scientific innovation, “said agency commissioner Dr. Stephen Hahn at a news conference.
The developer has provided data showing that there is no detectable level of alpha-gal sugars in several generations of genetically modified pigs.
This gives them the green light to sell meat for food.
At the same time, work began to demonstrate more ambitious intentions for therapeutic use. As a creation and demonstration of safety and efficacy of medical products. For example, hypoallergenic heparin, which contains no detectable alpha-gal sugars. Heparin is a widely used anticoagulant that is commonly produced from porcine intestines. And therapy is inappropriate for alpha-gal syndrome.
Genetically modified pig tissues and organs have the potential as an alternative in cases of immune rejection. In patients requiring xenotransplantation, the high risk is believed to be a rejection reaction due to alpha-gal sugars.
Xenotransplantation is a procedure that involves the transplantation of tissues or organs or the infusion of cells of animal origin. Its development is also driven by
the need
from the authorities to
transplant that far exceeds donation.
However, innovative therapies have a great impact in clinics. To enter human medicine, xenotransplantation products must be approved by the regulatory agency based on evidence from clinical trials. The first step in certifying safe pig tissue medical products for alpha-gal is a phase 1 safety clinical trial at the Hospital of the University of Massachusetts. Pigskin has long been used in the treatment of thermal injuries. The team will now use the skin of the pigs modified for grafts in people with burns who have an allergy to alpha gel.
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