As many of you may know, Dr. Cole is now offering the option of ACell treatment to his hair transplant patients. Although he does not have much time to spend on the forums himself, Dr. Cole understands that there are a lot of questions, and some controversy, surrounding ACell; he believes it is important to get some honest information out to the public. The following are some of Dr. Cole’s thoughts on ACell, as transcribed by myself:
“ACell is a method of tissue engineering that I have been monitoring closely for many years. The term ‘tissue engineering’ was coined in 1988. It is defined as the application of the principles and methods of engineering and life sciences toward the fundamental understanding of structure function relationships in normal pathological mammalian tissue, and the development of biological substitutes to restore, maintain, or improve tissue function.
ACell is an extracellular matrix derived from the porcine basement membrane of bladder (from the basement membrane of a pig’s bladder). An extracellular matrix is the tissue between the cells; it is composed of collagen and fibronectin. It is also composed of “gags” glycosaminoglycans. A number of the components of extracellular matrix are bioactive molecules. Extracellular matrix also acts as a potent modulator of cell behavior. A number of growth factors can be found with extracellular matrix including VEGF, BFGF, EGF, transforming growth factor beta, keratinocyte, hepatocyte growth factor HGF, and platelet derived growth factor. There are additional growth factors as well. Extracellular matrix has been noted to act like a mediator of cellular behavior. In other words, when the matrix is placed in the injured tissue it attracts and stimulates cells. It attracts important components of tissue regeneration, which are stem cells. You could say it acts like mom’s good cooking and brings the family to the table. Essentially, it tells cells what to do and when to do it. It also stimulates them through a variety of growth factors. The extracellular matrix acts as a scaffold for the stem cells. Stem cells are pluripotent. The extracellular matrix helps to differentiate them into cells that will produce a single structure. The one concern we have with ACell products is a possible allergy to any component of the pig or porcine. Most people do not display an allergic reaction to pigs therefore ACell is thought to be safe for most individuals.
What does ACell do? When ACell is applied onto injured tissue, it can stimulate the regeneration of normal tissue. It is not going to re-grow an entire arm that has been cut off, an entire liver that has been removed or an entire finger that has been excised. It will, however, help to regenerate small areas of tissue.
What has ACell been used for in the past? ACell has been used to re-grow esophagus tissue that has been excised due to cancer, bladder tissue that was excised due to cancer and a tympanic membrane. ACell has even been used to re-grow muscle over a soldiers leg wound and has been able to increase muscle performance by 15%. In this latter situation, ACell was applied to the quadriceps of a soldier who had suffered a traumatic injury, and the loss of the majority of his quadriceps muscle, in a Middle Eastern front. The ACell was applied to this area and the soldier was able to re-grow functioning muscle tissue that resulted in an improvement in muscle function by 15%. ACell has also been used to treat damaged heart, or myocardial, tissue that was injured subsequent to a heart attack or vascular inclusion.
What is our interest in ACell? Our interest is in the use of ACell to re-grow normal skin tissue in our extraction sites. We are currently applying ACell into our extractions sites with the hope that it will re-grow normal skin. We also apply the ACell into the extraction site with the hope that it will stimulate or attract stem cells from the extracted hair follicles and induce them to produce normal hair. We apply ACell to our grafts, as well, in case any grafts are injured such that it may repair any injury to the grafts and improve our overall yield. Of course ACell also contains growth factors, much like PRP. PRP, or Platelet Rich Plasma, is exceedingly rich in growth factors. ACell has growth factors of its own; therefore, the ACell should help stimulate healing and promote faster healing.
What do we know about ACell thus far? We really don’t know much about ACell with regard to hair restoration surgery at this time. We have seen some reports by Jerry Cooley and Gary Hitzig. The reports thus far seem to be inconclusive. It appears that the ACell was used primarily to treat strip surgeries. The data from these colleagues is thus far lacking in evidence that ACell will prove beneficial in strip harvesting.
My primary interest in ACell is in helping our donor areas take on a more natural appearance following follicular unit extraction performed by my method: the Cole Isolation Technique (CIT). Some individuals who undergo follicular unit extraction will develop areas of hypopigmentation where the hair was removed. These areas of hypopigmentation can lead to a phenomenon that some individuals refer to as a “moth ball” appearance. The application of ACell may help these unfortunate individuals develop more normal tissue and much less hypopigmentation such that the appearance of the extraction sites is aesthetically superior. I want to emphasize at this point that we are not certain whether ACell will function to reduce hypopigmentation. Indeed, hypopigmentation is primarily a function of lost circulation and a loss of hair pigment from the extraction sites; it really is not due to significant formation of scar tissue. Nevertheless, ACell may help to improve melanocyte stimulation and improve the overall appearance of the donor area.
My second interest in ACell is to stimulate the stem cells which are left behind when we perform follicular unit extraction. Stimulation of these stem cells by ACell may induce the development of new hair growth. I feel that ACell is particularly well suited for follicular unit extraction. This is because, unlike strip surgery in which you extract the entire strip of tissue including the adipose, the hair follicles, the dermis, and the epidermis, we remove only the outer dermis and the hair follicles in FUE. The remainder of the tissue, including any residual stem cells related to the hair follicles, is left behind and intact; I emphasize fully intact. This is why scarring from follicular unit extraction is always less extensive than scarring from strip surgeries. The extractions by my method of follicular unit extraction, “CIT”, are far less invasive than strip surgery. So, the hope is that through our proprietary method of delivery of ACell to our extraction sites, we will be able to attract and induce hair follicle stem cells to reproduce a re-growth of the extracted follicles. I close this paragraph by emphasizing that we have not yet seen any evidence that ACell promotes any new hair growth.
The reason we have not seen any significant benefits from ACell thus far is that we have been using the product only for the past month. I wanted to wait for some time after the release of the product to evaluate its safety profile. You may be aware that I have been following ACell very closely since the spring of 2007. At that time, I was impressed with ACell’s ability to re-grow the tip of an amputated thumb. However, at that time, ACell was not indicated for use in humans. As such, I wanted to wait for FDA approval for use in humans, and also to evaluate the safety profile of the product. My primary concern, once again, with ACell was an allergic reaction to porcine products. As you may be aware, ACell is derived from the basement membrane of the pig. It is washed, cleansed and sterilized prior to delivery to the physician’s office. In my opinion, it is an extremely safe product.
There’s a great deal more that can be said about ACell and we will expand on these thoughts in due course. It is very important for everyone to recognize, at this time, that there is no conclusive evidence that ACell stimulates the regeneration of new hair. There is, however, substantial evidence that it regenerates new skin. From the standpoint of hair regeneration, ACell remains experimental. From the standpoint of regenerating new skin, it is a proven modality that may work to a variable degree depending on the individual patient. Even should ACell fail to stimulate new hair growth, it almost certainly will improve the overall aesthetic appearance of follicular unit extraction sites in the donor area. ACell is a very expensive product; we have purchased a considerable amount of it. We are offering it to our patients with explicit informed consent at a price that does not exceed our costs. Of course, patients are under no obligation to receive ACell treatment.
The objective going forward is to unlock the specific methods necessary to regenerate hair. Given that ACell has successfully regenerated muscle, skin, nerves, specific organ tissue, etc., we see no reason why it cannot regenerate hair. It is left to us to engineer a specific means of delivering the product to the appropriate stem cells.
There’s perhaps no one that understands the pain of hair loss more than the individuals in these forums. As a professional in hair restoration surgery for over 19 years, I’ve seen far more casualties of poorly performed hair restoration procedures than I can bear to recall. I can tell you that working with these individuals has created a degree of emotional distress for me, personally. Sometimes we have very few options, and other times we have no options. In essence, these are individuals who are without hope. There are some who would question why I press the envelope on experimental procedures, such as ACell and BHT. The answer is simple: if you could look into the heart and soul of an individual who is practically hemorrhaging inside due to their hair loss, their lack of donor hair, and the cosmetic disfigurement of their prior procedures, you would understand why I will not give up my quest to find a solution for these troubled men and women.”