Isolagen:
A New Horizon?

S ince 1982, when collagen was first approved for use in humans, not much has really changed in the collagen soft tissue augmentation market. The bovine collagen that was initially used was cross-linked for additional stability and the concentration of collagen was increased in order to increase density. Collagen harvested from cadaveric sources was around for a while without a significant benefit to cosmetic outcomes and it quickly passed away. More recently, collagen cultured from fibroblasts derived from the foreskin of neonates has been added to the mix of available injectables. These products (from Inamed) closely resemble the bovine-sourced products with respect to concentration and technique. One leap in collagen technology appears to be around the corner with the potential introduction of Isolagen. A New Technology Isolagen utilizes a technology that grows a patient’s dermal cells ex vivo for injection. The process begins with harvesting of a donor sample that is typically removed from the area behind the ear. Fibroblasts are cultured at the company until there is at least 1 ml to 1.5 ml of material for injection. Cultured product contains fibroblasts, native collagen and other factors that are, theoretically, essential for persistence of the soft tissue correction. The average time for culture is between 4 to 6 weeks. This means that at the initial consultation, you’ll need to discuss various filler options, and if the patient decides to undergo treatment with Isolagen, a biopsy will take place after which the patient will need to wait. This waiting process may be a barrier for some patients that desire correction at the first visit and this is one consideration that will determine how widespread the procedure becomes. Once you receive the material back from the lab, it is injected back into the patient during a series of visits — typically at 2-week intervals. How many visits will be needed and how much material is optimal remains to be defined. Theoretically, this process offers the possibility of having persistent correction due to continued production of collagen and elastic fibers by the native, expanded fibroblasts. Anesthesia for this process will either consist of nothing, topical medications or injections of local or regional blocks. Whether or not the use of anesthetic agents has an affect on the survival of the fibroblasts will need to be studied to determine if the the transient pH change kills the fibroblasts. Clinical Trials Clinical trials with this product are presently underway in the United States. To my knowledge, the material is under study for cosmetic indications such as the nasolabial creases. From an intuitive basis, it seems reasonable to expect that there will also be clinical trials for this product for indications such as wound healing and correction of acne and skin cancer scars. I would also expect that in time, we will see different concentrations of material offered to satisfy the requirements of different sites for injection (for example, the tear trough would need lower density than the marionette lines). Known Benefits The benefits of autologous material are numerous. Most significant among these is the fact that the correction may be durable and the fibroblasts might continue to produce native collagen for a long time. Since this collagen is not foreign, the body’s immune system will not attack it. Autologous material also has the benefit of growth factors needed to stabilize and stimulate persistent collagen production. Other benefits include no risk of foreign body reactions and infections that are theoretical problems with harvested materials. Questions to be Answered Costs for the procedure are not yet known (or at least are not known by me). Based on the amount of filling that would occur, I would guess that the charge for growing the culture will be about $450. To my way of thinking, the procedure will require a consultation, punch biopsy and injection. Add these to my hypothetical culture price and it’s likely that each injection of Isolagen will cost patients about $1,000 in many major markets. And, as with every cosmetic procedure, there probably will be those physicians and non-physicians at the fringes of cosmetic surgery who will offer the procedure for discounted rates, and some who will try to split an aliquot of harvested collagen into two sessions or mix it with other fillers to try to extend the volume. Although Isolagen is exciting, we still have a great deal to learn about techniques and optimal treatments with it. One can imagine that the material might be combined with a hyaluronic acid matrix to support and nourish the cells. Growth factors may be added to improve survival and yield from the products. In addition, it and subsequent products may be treated with light sources or lasers specifically designed to stimulate yield. The possibilities are numerous. I’m interested to see how the product evolves over the next few months. Hopefully, the manufacturer will realize its potential and invest in the research and training needed to make this product successful.