Results announced from a prospective, open label, phase II study (IT-R-007) of two treatments of Isolagen Therapy in multiple facial regions ("full face") for facial wrinkles and creases in approximately 40 subjects reported improvement in the appearance of wrinkles as scored by a high percentage of both study subjects, as well as independent panel evaluators. The same results were reported regarding improvement in skin quality. At six months following the final treatment, 83 percent of subjects reported an improvement in their self-assessed score of the appearance of wrinkles. At the six-month point, the results from the independent panel evaluation of study photographs also showed improvement in the appearance of wrinkles, with the independent panel scoring improvement in over 75 percent of participants.
SKIN SCAFFOLDS"This current study, conducted at five U.S. sites, is a strong research base that not only covers [Isolagen's impact] on wrinkles, but also skin rejuvenation. This therapy is like introducing scaffolding to the skin —a way to prepare the skin for other treatments," says Declan Daly, president and chief executive officer, Isolagen, Inc.
COMPLICATIONS AND COST
Complication and expense of harvesting, storing and administering patients' own cells is the primary concern surrounding Isolagen's ultimate success. While taking a biopsy from the behind the ear to create the injection is simple, the overall cost of growing and multiplying the fibroblasts for its final destination causes concern. Isolagen treatment ranged from £2,500 to £5,000 when offered in the UK in 2002, and $4,000 per patient in the U.S. at last estimate (2004).
Yet, if a patient makes the investment upfront with a "full-face treatment," followed by a yearly treatment, the price is probably not going to be much different than receiving filler treatments three times a year, explains Mr. Daly.
"These issues are yet to be determined based on pricing and education of physicians and patients," says David H. McDaniel, M.D., F.A.A.D., director, Institute of Anti-Aging Research, Eastern Virginia Medical School, and assistant professor of Clinical Dermatology and Plastic Surgery, Eastern Virginia Medical School, Virginia Beach, Va. "The biopsy process is very simple and safe, and over the long term Isolagen will likely prove to be very cost effective because of it duration of benefits."
As for its "competition," both Mr. Daly and Dr. McDaniel agree that Isolagen should not be considered a competitor to fillers, but rather a nonsurgical alternative to peels and laser procedures.
"Fillers are primarily volumizers, whereas I view Isolagen more as 'replacement therapy.' That is, Isolagen is restoring or augmenting what was either lost or damaged from aging," says Dr. McDaniel, who is also co-director, Skin of Color Research Institute, Hampton University. "It may be competitive for some of the very fine-line fillers that have a short-lived effect, but predominantly this is a new tool for the cosmetic surgeon to add to his or her menu of therapies."
Using a 29-gauge needle, proper administration of Isolagen is technique sensitive, and training will be vital as it differs from administering injectable fillers, according to Dr. McDaniel. "However, this is simple to train and the biopsies are very easy — I do not foresee a significant problem overall."