(RxWiki News) Three patients with end stage renal disease mark the first to successfully receive blood vessels engineered in a lab from human skin cells. Following additional testing, "off the shelf" blood vessels could be as readily available as medical gauze.
Lead researcher Dr. Todd N. McAllister, Ph.D., co-founder and chief executive officer of Cytograft Tissue Engineering Inc., of California presented the study in an American Heart Association Emerging Science series webinar.
In addition to improved affordability and ease of kidney dialysis patients, the manufactured blood vessels also could be used for congenital heart repairs in pediatric patients, heart bypass operations and soldiers at risk of losing a limb.
"New blood vessel technology is not yet available outside a clinical setting."
The patients who received the blood vessels were all dependent upon groin catheters, had been on dialysis for at least four years, and had a life expectancy of less than 12 months. It has been eight months since the blood vessels were inserted and the patients have had no immune response to the implants and the vessels are withstanding the frequent needle punctures required of dialysis.
Traditionally used shunts, made from synthetic material or a patients' own blood vessels, are prone to failure.
McAllister previously demonstrated that vessels created from a patient's own skin cells dramatically reduces shunt complications. Availability of ready-made vessel could cut the cost and shorten the lengthy period required for making custom blood vessels for each patient.
This would make it more available on a worldwide basis.
A previous phase of the study involved implanting vessels created from a patient's own cells in a dozen patients, but while successful, the procedure proved too lengthy and costly.
The tissue-engineered blood vessels were manufactured from large sheets of cultured skin cells that are rolled around structures for temporary support. In the three patients, those structures created access shunts between arteries and veins in the arm for dialysis.
The sheets are considered to be of high mechanical strength. It takes about six months to grow the grafts in a lab. It is estimated that each blood vessel would cost between $6,000 to $10,000.
"It appears to be safe. These are high-risk patients where we would expect three interventions a year," McAllister said. "This drop in events is truly remarkable."
McAllister said he is confident blood vessels could be built for more than 100,000 patients from one master cell line. Currently about 350,000 Americans are in need of such grafts.
McAllister said the only dilemma had been that the small diameter can make puncture difficult, however the vessels are believed to be more resilient to repeated punctures. A third clinical phase that will involve implanting the blood vessels in to up to 100 patients will begin this summer.
The study was funded by Cytograft Tissue Engineering.