Kenneth Williams Jr., D.O., FISHRS, a broad certified hair restoration surgeon in Irvine, California, talks about a stem cell study that may help men and women suffering from hair loss disorders.
Interview conducted by Ivanhoe Broadcast News in November 2016.
Tell us about this stem cell study for baldness.
Dr. Williams: I began this study about two years ago. It was passed down for me to implement by a colleague, but I really became interested in stem cells about eight years ago in its application in cosmetic hair surgery. I was introduced to Dr. Robert Alexander, who explained to me of the concept of bio cellular material and stem cells that can enhance and regenerate hair follicles. My path began and the initial research efforts eventually matured into a point where we could go ahead and start the study and enter patients into these treatment protocols.
How does Stem cell Therapy work?
Dr. Williams: It involves a lipo aspiration procedure of fat around the abdomen or the hips. It also involves blood taken from the central venous vein and from that we get high density platelet rich plasma (HD-PRP). We’re getting platelet’s which are rich in growth factors that help stimulate hair follicles, and we’re also getting stem cells along with some stromal cells to help with the regenerative stimulation of inactive hair follicles. I have to say that everything is theory right now, we have no data indicating the response or how successful we are. We’re now just entering patients into the study. This is a great opportunity because stem cells have three thousand applications in medicine, and we know that they work. It’s just that the data is on the low side for its impact upon hair. We have two published papers right now, one from Dr. Fukuoka, Kyorin University, Tokyo, Japan; and a Dr. Ibrahim from the University of Cairo, Egypt. These two studies indicated that mesenchymal stromal cells can help with regeneration of hair follicles. We aim to obtain data and publish it in about two years. What we need now are just patients to come in to the study.
I’m sure that it’s a very stressful condition to have hair loss that you won’t have any shortages of patients. What are they telling the patients?
Dr. Williams: Hair loss is a very emotional impactful disorder both to men and women. Especially for women who have hair loss. Just a little bit of hair loss may not be apparent when you look at the individual, but they tell you that they’re suffering from hair loss and the amount of shedding and loss impacts their self-esteem and confidence, it’s a very compelling story. Men and women do suffer from hair loss and can benefit from what we’re doing here.
How will a stem cell know to make hair?
Dr. Williams: We have to differentiate stem cells from hair cloning. Hair cloning is where we’re actually taking the cell and creating a new hair follicle; you’re growing the hair cells in media, that’s not allowed right now in the United States; the only country where cloning is legally allowed is in England. This study is taking cells that are in our body to help to regenerate or stimulate inactive or dormant hair follicles. That is the theory behind this procedure.
Will the stem cells will be injected near the hair follicle stimulate the hair follicle to work again?
Dr. Williams: That is true. We’re taking these regenerative cells from the body and we’re putting them back in to the scalp where we have “cell-to-cell” signaling. We have these secreatones and other bio active regenerative chemicals that go out and signal these inactive hair follicles to be active again. That’s the basic theory behind what we’re doing.
How does the PRP come in to play?
Dr. Williams. That’s a good question. PRP, which stands for platelet rich plasma, is very simple to obtain. We get it from a blood stick in the central venous vein. We take about sixty (60) ccs of blood and from that we can concentrate the platelets up to five, six times their baseline concentration, to get a whole lot of platelets. The platelets themselves have growth factors that are very important in stimulating cells to grow. We put all these cells back in to the scalp and looking for and hopefully going to have some results.
Tell me about the procedure.
Dr. Williams: We have three clinical arms. The third arm, which has a significant amount of biocellular material in stem cells, takes three (3) hours to perform. From that we do a liposuction procedure; we actually create everything from a particular device called a Healeon Centricyte. We do flow cytometry to determine our cell viability as well as the number of cells that we have. We get some really good objective data here, and we know everything that we’re injecting back into the patient’s scalp. Everything is closed in a sterile system. There’s no contamination, it’s a sterile product from the very beginning to the end.
You liposuction the fat out, the blood out, spin the blood down and then what do you do after you have to separate the stem cells from the fat?
Dr. Williams. Now we’re talking about something that gets into the intricacy and details how we do this procedure. Basically, we emulsify or “melt” the fat.
Melting it?
Dr. Williams: Melting it figuratively, but making it in to a liquid so we can actually inject the biocellular material with a twenty seven (27) gauge syringe (which is a very small syringe) into the scalp. We’re not using eighteen (18) gauge or twenty (20) gauge needles. We’re using very small needles that allow the introduction of the biocellular material in to the scalp.
You’re not actually having to separate the stem cells as you’re melting it all down, or are you?
Dr. Williams: Part of the process with the Healeon Centricyte is the actual cell separation where we get stromalvascular fraction (SVF), which is high numbers of these stem cells. It gets a little bit more complicated for the average viewer.
Simply so I can break it down and make it somewhat interesting, you are separating some stem cells?
Dr. Williams: The question has to do with the actually process of how you get stem cells from the fat using the Healeon Centricyte. That process requires a collagenase enzyme that helps to break down and separate the stem cell from the fat cell, because we don’t really need the fat cells. We just want the stem cells. It’s a process that has been created by Dr. Patricia Zuk from UCLA. We use shaking, increase the temperature of the solution, and this separates the stem cells. We purify it, we wash it, and neutralize it, along with a few other important steps in the process. In the end, we have pure stem/stromal cells that we’re injecting in to the scalp.
Do you mix that with the PRP or do that separately?
Dr. Williams: Everything is mixed together right before we actually inject it into the scalp.
Then do you inject it just where you want the new hair or all over?
Dr. Williams: It’s done under a local anesthetic. We do what we call are ring blocks in the front and in the back of the scalp. The patient, after the ring block is received, doesn’t feel the injections. We do about three hundred injections into the scalp. We start centrally in the scalp and work our way to the periphery down in to the sides of the temporal, parietal and occipital portions of the scalp.
Are there any side effects?
Dr. Williams: The side effects are minimal. Pain obviously will be experienced and a little bit of Tylenol will help to handle and decrease it. There may be a little bit of fluid that is retained in the frontal forehead because we’re injecting so much material. There’s a little discomfort where we perform the liposuction, but it is very well tolerated procedure. We have many patients that don’t want any sedation and they do very well without any discomfort. Then there are some patients who want the sedation because they don’t want to experience any pain. We give options for patients.
How many people are in the study so far?
Dr. Williams: Right now we have three that are scheduled, and we’ve done one. I’ve been doing the procedure on private patients for the past year. We have strict inclusion and exclusion criteria so some of these patients are excluded because of previous diagnosis or because of certain conditions. Once they meet or pass the inclusion-exclusion criteria, then they actually are entered in the study and the study consists of two injections three months apart.
What are the results so far?
Dr. Williams: There are patients are seeing some difference in the density of the hair. We’re waiting for the final results. It takes about nine (9) to twelve (12) months after the scalp injections to see the final results of what we’re doing. It’s still very early. We don’t want to make too many promises to patients. Obviously nothing is guaranteed; we have only those two (2) published studies but we feel that our information will be validated and it will give us some positive results.
Who is not a good candidate for this?
Dr. Williams: Patients who are on hair loss treatment like propecla or finasteride, or patients who have what’s called scarring alopecias. Also, anybody who is on laser therapy that may contribute to hair growth, we have to exclude them from the study because that may introduce a bias. We’re only using patients who follow the three arms (ARMS 1,2,3). We’re following the results of PRP (ARM 1) , stem cells (Arm 2), and then “supersizing” stem cells (ARM 3).
The only reason they’re bad candidates is they would skew the study otherwise anybody can be a study patient?
Dr. Williams: Yes, anybody suffering from hair loss can participate in this study. If they don’t meet the inclusion, exclusion criteria for the study, they can always come as private patient to get the procedure done. We don’t want to exclude anybody, everybody is welcome.
But it costs twice as much did you say?
Dr. Williams: We give a little bit of a financial break for those patients who are in the study, we give them an incentive. It’s a little bit more if it’s a private patient, but insignificant.
END OF INTERVIEW
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