Breakthrough in tissue engineering: a synthetic artery takes shape, revolutionizing trauma treatment with the approval of bioengineered blood vessels.
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The Food and Drug Administration (FDA) has recently approved a bioengineered blood vessel, marking a significant milestone in tissue engineering. This innovative technology has the potential to revolutionize the treatment of traumatic injuries.
Tissue engineering is a field that combines principles of biology, chemistry, and engineering to develop functional tissues for medical applications.
This multidisciplinary approach involves designing scaffolds, seeding cells, and culturing tissues in vitro.
Tissue engineering has shown promise in repairing or replacing damaged tissues, such as skin, bone, and cartilage.
According to the National Institutes of Health (NIH) , tissue engineering research has led to significant advances in wound healing, orthopedic implants, and organ transplantation.
Each year, approximately 185,000 people in the United States undergo amputation due to injured blood vessels cutting off circulation to a limb. Surgeons can transplant an intact vein from another part of the body, but not everyone has a suitable vein available. The new bioengineered blood vessel is designed to restore blood flow in patients with traumatic injuries, such as those caused by gunshots, car accidents, or combat.
Traumatic injuries occur when the body suffers damage due to an external force, such as a fall, car accident, or physical assault.
These injuries can range from minor cuts and bruises to life-threatening conditions like concussions and 'internal bleeding'.
According to the World Health Organization (WHO), over 5 million people die each year from traumatic injuries.
In the United States alone, trauma is the leading cause of death among children and young adults.
Prompt medical attention is essential in treating traumatic injuries, which often require emergency surgery or hospitalization.
Laura Niklason, founder and CEO of Humacyte, first became interested in growing spare blood vessels in the 1990s. She observed that veins are thin and weak, while arteries are strong, making them unsuitable for replacement. ‘Veins are like spaghetti, they’re very fragile,’ she said. Niklason experimented with growing blood vessels in the lab from just a few cells collected from pig arteries. The results were promising, and she continued to develop the technology.
Laura Niklason is a Swedish-American tissue engineer and researcher.
She is the founder of Humacyte, a biotechnology company that develops engineered tissues for medical applications.
Niklason's work focuses on creating functional vascular tissues using human cells and biomaterials.
Her research has led to significant advancements in organ transplantation and regenerative medicine.
The Development Process
Niklason and her team spent over a decade isolating blood vessel cells from human organ and tissue donors. They tested cells from more than 700 donors and found that those from five of those donors were the most efficient at growing and expanding in the lab. The company now has enough cells banked from these five donors to make between 500,000 and a million engineered blood vessels.
The Manufacturing Process
Humacyte currently makes the vessels in batches of 200 using custom-designed degradable polymer scaffolds that are 42 centimeters long and 6 millimeters thick. The scaffolds are seeded with millions of donor cells and placed in individual bags, which are then incubated for two months to allow the tissue to grow.
The bioengineered blood vessel is a safer alternative to synthetic options made of Teflon or polyester. These materials can cause infections and have a higher chance of rejection. The engineered vessel has been tested in 51 civilian patients and 16 military patients with traumatic injuries, and the results show that it remains open and functioning at a rate of nearly 92 percent compared to 79 percent for synthetic grafts.
A Promising Future
The FDA approval means that Humacyte’s vessel can only be used in trauma patients, but the company is pursuing other uses for its technology. It has tested the bioengineered vessel in patients on kidney dialysis and individuals with peripheral artery disease. The results are promising, and experts believe that this technology has the potential to revolutionize medicine.
The breakthrough of bioengineered blood vessels is a testament to human ingenuity and innovation. With its potential to prevent amputations and improve patient outcomes, it’s clear that this technology will have a significant impact on the field of trauma treatment.
