Vavelta: the future for foreskin?
If the name makes you think of a processed cheese product, you are sort of on the right track, since Vavelta involves an unnatural breed of processing. Manufactured by the British biomedical company Intercytex, Vavelta is a clear suspension of human dermal fibroblasts in cell storage medium. Since fibroblasts are responsible for the growth of collagen, Vavelta is intended to mimic the natural process of collagen production after being injected into the skin. The body does not reject fibroblasts as it does when injected with most other foreign substances.
In case you missed the lively discussion on Truth in Aging about human fibroblast conditioned media, you might be a bit unnerved by the fact that the fibroblasts being hailed as the magic ingredient in all forms of anti-aging products are derived from baby foreskins. Vavelta only uses foreskins donated by mothers at U.S. hospitals after a routine circumcision. These mothers and their babies are screened in advance, and the foreskins would be otherwise discarded. Once transported to the UK, the foreskins are chopped up into little pieces, treated with enzymes to release the fibroblasts, and left to flourish in a sterile lab. One foreskin makes enough cells for hundreds of thousands of treatments since the cells can be grown in cultures and then frozen.
Though the process is monitored by the FDA in the U.S. and the British Human Tissue Authority, some doctors are skeptical of its safety. Dr. Eric Siegel, dermatologist and founder of the Millburn Laser Center in New Jersey, calls it "one step after stem cell," since the only difference is that the human tissue is neonatal instead of fetal. In addition to infection, there might be any number of downsides to Vavelta, which have yet to be proven in tests.
Nonetheless, Vavelta seems to show promise for restructuring damaged skin, especially in cases of burns, skin ulcers, wounds, and acne scars. Intercytex's clinical trials indicate that Vavelta can make skin smoother and thicker, reducing the appearance of scarring and facial skin folds. It works from the inside by repopulating the lower layers of skin with millions of healthy young skin cells. Following an initial phase of trials that found a 75% improvement in wrinkle severity after injection with Vavelta, studies are ongoing to determine further effects on skin.
Unlike muscle relaxants, such as Botox, and dermal fillers, such as Juvederm and Restylane, Vavelta is claimed to be permanent, since it introduces the cells that make collagen instead of injecting collagen itself. While Botox costs upwards of $500 and fillers upwards of $600, a single vial of Vavelta carries a price tag of around $1,500, though this varies according to individual needs and responses to the treatment. Repeated injections are typically necessary, depending on the patient's skin condition, and visible results are expected to be gradual, as it takes time for the injected cells to stimulate changes in the extracellular matrix.
Besides typical redness and discomfort at the injection site, serious side effects could include permanent swelling, nodule formulation, and skin discoloration. As if that weren't disturbing enough, Vavelta is cautioned for use in anyone allergic to bovine or porcine products, which may be present in trace amounts, and to the antibiotics gentamycin or amphoteracin B, which are used in the production process.
Though Intercytex is in talks with the FDA to expand its market overseas, it will likely be years before Vavelta makes it to the U.S. We can only hope that there will be thorough clinical studies completed and stringent safety measures in place before the day when everyone is shooting up a cocktail of baby foreskins and pig traces.