An Uncontrolled Case Series Using a Botanically Derived, β-Cyclodextrin Inclusion Complex in Two Androgenetic Alopecia-Affected Male Subjects
Alan J Bauman
Abstract Drug-based monotherapy provides limited clinical benefits in polygenic disorders, such as androgenetic alopecia. Possible benefits must be measured against non-trivial risks of negative side effects. Several well-controlled, peer-reviewed, basic science studies have demonstrated novel mechanisms of action and potential utility for natural-based phytochemicals in the treatment of androgen-mediated disorders, including androgenetic alopecia. Yet, due to phytochemical instability, volatility, and incompatibility, the bridge from in vitro potential to clinical efficacy remains largely unmet. Recent advances in nanomaterial manipulation provide enhanced platforms, such as cyclodextrins, in which these phytochemicals may be enveloped and delivered without triggering the loss of intended function. Unexpected, positive results of an uncontrolled case series for a cyclodextrin-enabled, natural-based formula containing γ linolenic acid, β-Sitosterol, epigallocatechin gallate, and genistein, administered concomitantly via oral and topical form in two androgenetic alopecia-affected, male subjects over the course of 270 days were found. At baseline, significant baldness in the vertex scalp of both subjects was observed. Subsequent 90-day time points demonstrated marked hair thickening. On treatment day 270 (conclusion), scalp hair loss was no longer evident in either patient. Particularly in the setting of disorders such as androgenetic alopecia, nano-complexed, botanically-based compositions may offer beneficial adjunctives or alternatives to traditional drug-based/surgical medical treatments. Keywords: hair loss; advanced drug delivery; nanoparticles; natural hair loss treatment; phytochemicals; β-cyclodextrin
VirtualPRP™ and AnteAGE-MD Home Hair System from Bauman Medical
What is VirtualPRP™ and can it help with hair regrowth?
VirtualPRP™ is a powerful at-home protocol designed specifically by renowned Hair Restoration Surgeon and hair loss expert, Dr. Alan J. Bauman, MD. Virtual PRP can be used as an at-home stop-gap alternative to in-office PRP Platelet-Rich Plasma treatment. VirtualPRP is ideal for patients who are unable to visit the office for their scheduled or recommended in-office PRP treatment for regrowth. VirtualPRP and its components can also be used as a non-chemical, drug-free and side-effect-free adjunct to in-office PRP Platelet Rich Plasma Hair Regrowth treatments.
What kind of technology is included in the VirtualPRP at-home treatment protocol?
Dr. Bauman’s at-home VirtualPRP protocol includes a combination of breakthrough technologies such as bone marrow stem cell-derived growth factors and cytokines, a powerful polybotanical topical solution, an FDA-cleared low-level laser therapy device for hair regrowth, as well as stem cell support nutraceuticals.
The use of bone marrow stem cell-derived growth factors and cytokines, as well as powerful polybotanicals (AnteAGE-MD Home Hair System), are key components of Dr. Bauman’s VirtualPRP protocol. In 2019, Dr. Bauman initiated an in-house pilot study of the AnteAGE-MD’s technology and its effect on hair regrowth and presented some of his results at international medical conferences, including the South Beach Clinical and Aesthetic Dermatology Symposium and the Annual Scientific Congress of the American Academy of Anti-Aging and Regenerative Medicine. See some more Before and After Results from Dr. Bauman's AnteAGE-MD Pilot Study.
A novel strategy for stimulating hair growth using WAY-316606, an SFRP1 Antagonist via Wnt signaling pathway...
Fig3: Inhibiting SFRP1 activity with WAY-316606 enhances human hair growth, increases K85 protein expression, and inhibits spontaneous catagen ex vivo.
Recently touted in this popular news story entitled "Shampoo containing brittle bones drug allegedly triggers hair growth" http://www.foxnews.com/health/2018/05/09/shampoo-containing-brittle-bones-drug-allegedly-triggers-hair-growth.html, the scientific research behind this story and WAY-316606 is true and not "fake news," but the title is VERY misleading. This potentially hair-growing compound is NOT contained in a shampoo or gel in the ex-vivo studies (the studies were done in a petri dish, not on a scalp), and an over-the-counter remedy based on this technology is very, very far off--and may never come to fruition. Here is an excerpt from the original study below... --Dr. Alan Bauman, MD, ABHRS, IAHRS, FISHRS
Identifying novel strategies for treating human hair loss disorders: Cyclosporine A suppresses the Wnt inhibitor, SFRP1, in the dermal papilla of human scalp hair follicles
Nathan J. Hawkshaw, Jonathan A. Hardman, Iain S. Haslam, Asim Shahmalak, Amos Gilhar, Xinhong Lim, Ralf Paus
Published: May 8, 2018 https://doi.org/10.1371/journal.pbio.2003705
Hair growth disorders often carry a major psychological burden. Therefore, more effective human hair growth–modulatory agents urgently need to be developed. Here, we used the hypertrichosis-inducing immunosuppressant, Cyclosporine A (CsA), as a lead compound to identify new hair growth–promoting molecular targets. Through microarray analysis we identified the Wnt inhibitor, secreted frizzled related protein 1 (SFRP1), as being down-regulated in the dermal papilla (DP) of CsA-treated human scalp hair follicles (HFs) ex vivo. Therefore, we further investigated the function of SFRP1 using a pharmacological approach and found that SFRP1 regulates intrafollicular canonical Wnt/β-catenin activity through inhibition of Wnt ligands in the human hair bulb. Conversely, inhibiting SFRP1 activity through the SFRP1 antagonist, WAY-316606, enhanced hair shaft production, hair shaft keratin expression, and inhibited spontaneous HF regression (catagen) ex vivo. Collectively, these data (a) identify Wnt signalling as a novel, non–immune-inhibitory CsA target; (b) introduce SFRP1 as a physiologically important regulator of canonical β-catenin activity in a human (mini-)organ; and (c) demonstrate WAY-316606 to be a promising new promoter of human hair growth. Since inhibiting SFRP1 only facilitates Wnt signalling through ligands that are already present, this ‘ligand-limited’ therapeutic strategy for promoting human hair growth may circumvent potential oncological risks associated with chronic Wnt over-activation.
Hair loss is a common disorder and can lead to psychological distress. Cyclosporine A, a fungal metabolite commonly used as an immunosuppressant, can potently induce hair growth in humans. However, it cannot be effectively used to restore hair growth because of its toxic profile. In this study, we used Cyclosporine A as a lead compound to identify novel therapeutic targets that can aid the development of new hair growth–promoting agents. Through microarray analysis, we found that the level of the secreted Wnt inhibitor, SFRP1, was significantly reduced by Cyclosporine A. This inspired us to design a new pharmacological approach that uses WAY-316606, a reportedly well-tolerated and specific antagonist of SFRP1, to prolong the growth phase of the hair cycle. We show that WAY-316606 enhances human hair growth ex vivo, suggesting that it is a more targeted hair growth promoter with the potential to treat human hair loss disorders.
At Bauman Medical, we are closely monitoring these types of research studies which may give rise to safe, therapeutic treatments for hair loss for our patients in the future. Stay tuned for further updates at https://www.baumanmedical.com Hair loss suffers may request a private Virtual Consultation (Skype or FaceTime) or In-Person Consultation with #1 Top Hair Restoration Surgeon, Dr. Alan J. Bauman, MD, ABHRS, IAHRS, FISHRS.
For some, the idea of laser beams conjure up images of epic SciFi battle scenes. For others, lasers in medicine mean skin resurfacing or perhaps even hair removal. Today we see “lasers for hair regrowth” advertised in magazines, on TV and in our Facebook newsfeeds. Are these treatments for hair loss for real or is it just a gimmick… another bogus ‘snake oil’ treatment? How can lasers affect hair follicles or other parts of the body? Who is a candidate for laser hair therapy? Are there any side effects? What are the limitations of laser treatments for hair loss? How do I choose the best laser? How can I measure laser therapy results?
Low Level Lasers Explained
Far below the power required to blast away cancer cells, kill hair follicles – or evil aliens, for that matter – “Low Level Laser Therapy” is the use of non-cutting, non-burning or ‘cold’ lasers that impart energy to living cells without damaging them. Since their discovery in the 1960’s, low-level lasers have been proven to be an effective drug-free way to help heal wounds, relieve pain, increase circulation, decrease inflammation and provide a host of benefits to the human body and now we know why.
How Do Lasers Help Prevent Baldness?
First, it’s important to realize that all hair loss is not the same. “Alopecia,” the broad medical term for hair loss, can mean a huge variety of different medical conditions that decrease or eliminate hair follicle function causing everything from increased shedding to extensive baldness. When hair follicles, the mini-organs under the skin that produce your visible hair fibers, “fail,” there could be a wide range of causes which require accurate diagnosis and treatment by a hair loss specialist. If hair follicles are weakening, producing thinner, shorter and wispier hair, laser therapy may be an excellent non-drug, no side-effect option to improve hair growth. When low level laser energy is consistently applied with the correct power and regimen, improvements in hair growth can be easily measured and eventually felt and seen.
What Laser Device is Right for Me?
Today, laser hair therapy devices come in all shapes, sizes and costs. There are large, in-office devices, at-home portable caps, helmet and dome-shaped devices as well as the consumer laser brushes, combs and “band” lasers. Each device may have different types or a combinations of light sources (laser and non-laser), numbers of laser diodes, types of laser diodes, areas of coverage, treatment times as well as other factors that impact use such as comfort, size, weight, cord vs. cordless, etc. With so many laser devices FDA-cleared for hair regrowth in men and women, how can patients choose which device will work best? For our patients at Bauman Medical, we recommend exclusively devices that meet the following criteria:
“Pure” laser - (no LEDs or non-laser light sources)
Over 200 laser diodes for maximum coverage
Cordless, rechargeable for portability and ease of use
FDA-cleared for hair growth in men and women
Hands-free (no movement or readjustment during treatment required)
Discreet (fits under a standard baseball or other cap/hat for easy compliance)
The easiest way to understand the benefit of a “good quality” laser is the difference between watering your front lawn with a watering can versus an automatic sprinkler system… both theoretically can work, but one method requires significantly less time, effort and energy. When searching for laser device, know that like most electronic equipment (TV, stereo, car, etc.) you get what you pay for in terms of power, effectiveness and durability. A quality laser will last you a long time, and because it’s a one-time expense, laser therapy is actually your least costly hair loss treatment over the long-run. Therefore, it’s recommended to “stretch” a little when making this kind of long-term investment in your hair’s health and also make sure you measure and track your results over time with a qualified medical professional.
How Do I Know My Laser Is Working to Help Hair Growth?
Knowing what treatment will work best requires an accurate diagnosis, effective treatment regimen, compliance with the regimen and routine follow-up tracking measurements. This is most easily accomplished with an in-office visit and consultation with board-certified Hair Restoration Surgeon like Dr. Alan J. Bauman, MD, ABHRS. During your initial consultation, scientific HairCheck measurements are obtained from several different areas of the scalp to benchmark your baseline as well as track your progress over time from treatment. At Bauman Medical, after your initial consultation, all follow-up HairCheck measurements are performed as a courtesy to all of our patients at no-charge! Hair loss question? Get answers from Dr. Alan Bauman.
According to data released by Replicel on March 14, 2017, "The five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia."
DSCC therapy is the keystone technology for Replicel's RCH-01 product. Replicel reports that the first-in-human data on long-term safety endpoints for RCH-01 successfully met it's endpoints as they move forward toward further research, development and commercialization of the hair loss product in collaboration with Japanese company Shiseido.
According to Replicel, histological examination of the injection sites via biopsies at 6, 12, 24 and 60 months after treatment on 19 patients revealed no significant pathology (tumor, granuloma, foreign body formation, etc.)
In addition, efficacy data--while not statistically significant--revealed that there was a overall stabilization of hair loss in all participants as well as up to a 21% improvement in hair density in a top tier responder (average 4.2% increase in hair density overall).
Replicel Chief Scientific Officer, Dr. Kevin McElwee, alluded to further research focusing on designing optimal cell number (dosage) and injection frequency (timing) to optimize peak efficacy in terms of increased hair density. From his statements, it appears that smaller cell doses and more frequent treatment sessions may be used to achieve a superior effect in terms of increasing hair regrowth.
“In summary,” stated RepliCel’s President and CEO, R. Lee Buckler, “we are very pleased with the results of this first-in-human study and are excited to move this product forward into the next phases of development.”
At Bauman Medical in Boca Raton, FL we are actively watching this--and other--continuing research in the field of cell therapy for hair regrowth in androgenetic alopecia (pattern baldness in men and women). We are hoping to see the hair measurements of the hair regrowth performed with the HairCheck device which can be used to measure results from hair loss treatments such as PRP with Extracellular Matrix, SVF, MSCs, adipose stem cells or other cell therapy, compounded Formula 82M minoxidil, topical finasteride, laser therapy, hair transplantation and more.
Thanks, Neal. Our JAK program continues to progress as expected with ATI-5001 for oral administration for the treatment of the most severe forms of alopecia areata -- that's alopecia totalis and alopecia universalis -- and ATI-5002 for topical administration, primarily for the patchy forms of alopecia areata.
We are pleased to report that the IND application for ATI-5001 has been submitted to the FDA, and we expect to begin a human pharmacokinetic/pharmacodynamic -- that's a PK/PD study -- before the end of this year, which is slightly ahead of schedule. For the topical version, the ATI-5002, we are on track to submit an IND application and begin a clinical trial in the first half of 2017, which is consistent with our previous guidance.
In addition to progressing our JAK treatment program for the treatment of alopecia areata and as we reported on our last call, we have initiated preclinical development of additional JAK inhibitors which we are developing for topical use both in vitiligo and androgenetic alopecia, which is also known as male or female pattern baldness. The program includes the development of ATI-5003, which is a covalently binding JAK3-specific inhibitor, and the preclinical and formulation work continue to progress as expected.
At Bauman Medical Group Hair Transplant and Hair Loss Treatment Center in Boca Raton, FL we will be keeping a close eye on this groundbreaking hair loss research as it progresses.
Photo: Hair is seen growing out of skin cells derived from iPS cells and grafted onto the belly of a mouse. | Riken / kyodo
Japanese scientists said Saturday they have bioengineered the skin organ known as the integumentary system in mice using induced pluripotent stem (iPS) cells.
The achievement is likely to lead to further progress in regenerative medicine to treat severe burns, skin diseases and hair loss as the organ contains all the layers of skin tissues and appendages, such as hair follicles and sebaceous glands.
The group, made up of members from the Riken research institute, Tokyo University of Science, Kitasato University, Organ Technologies Inc. and others, cultured iPS cells from mice in vitro for one week and observed the formation of embryoid bodies with epithelial and mesenchymal cells. Next, the team, led by Riken’s Takashi Tsuji, transplanted some 30 such bodies with collagen gel in live mice.
Somewhat similar to the work that's been done at Sanford Burnham in California, Japanese scientists have grown hair follicles from bioengineered skin cells using iPS (induced pluripotent stem cells) in mice. Although there is a long way to go to achieve "unlimited" hair for humans, these research breakthroughs the beginning of stem cell hair loss "cures" which may be helpful for those suffering from various forms of alopecia. Male and female hair loss sufferers often lose self-esteem and self-confidence as coverage of the scalp diminishes due to hereditary (androgenetic alopecia) and other baldness conditions.
At Bauman Medical, we watch these stem cell hair growth breakthroughs with great anticipation and excitement and are looking forward to the day that this kind of therapy will be available for our hair loss patients! Sincerely, Alan J. Bauman, M.D. - Diplomate, American Board of Hair Restoration Surgery
This is a reprint of a MedicalResearch.com Interview with: Dr. Nana Keum, PhD Department of Nutrition Harvard T.H. Chan School of Public Health Boston, MA
Medical Research: What is the background for this study? What are the main findings?
Dr. Keum: Male pattern baldness, the most common type of hair loss in men, is positively associated with androgens as well as IGF-1 and insulin, all of which are implicated in pathogenesis of colorectal neoplasia. Therefore, it is biologically plausible that male pattern baldness, as a marker of underlying aberration in the regulation of the aforementioned hormones, may be associated with colorectal neoplasia. In our study that examined the relationship between five male hair pattern at age 45 years (no-baldness, frontal-only-baldness, frontal-plus-mild-vertex-baldness, frontal-plus-moderate-vertex-baldness, and frontal-plus-severe-vertex-baldness) and the risk of colorectal adenoma and cancer, we found that frontal-only-baldness and frontal-plus-mild-vertex-baldness were associated with approximately 30% increased risk of colon cancer relative to no-baldness. Frontal-only-baldness was also positively associated with colorectal adenoma.
Medical Research: What should clinicians and patients take away from your report?
Dr. Keum: While the relationship between male pattern baldness and prostate cancer risk has been widely examined, to our knowledge, this study represents the first to report a potential relationship between male pattern baldness and the risk of colorectal neoplasia. Thus, our findings should be confirmed in other studies before making definite clinical recommendations. Yet, in the meantime, it may be prudent for males with frontal-only-baldness or frontal-plus-mild-vertex-baldness at age 45 years, although their elevated risk is modest, to consult physicians about colonoscopy screening guidelines.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Keum: To better understand etiologic mechanism linking male pattern baldness to colorectal neoplasia, future studies are warranted to examine the association of sex hormones, IGFs, and insulin in relation to subtypes of male pattern baldness.
Hair is often an important outward sign of internal health and hair loss conditions are often associated, exacerbated or triggered by medical conditions. In this recent study we see the first published correlation between subtypes of hereditary male pattern baldness and the appearance of and increased risk of neoplastic colon polyps or colon cancer. --Dr. Alan Bauman
Is shedding normal after PRP Platelet Rich Plasma Hair Regrowth treatment using BioD Extracellular Matrix ECM?
In a word, YES. Because of the natural cycling of hair follicles (on and off, essentially) when you stimulate the hair follicle using a strong hair regrowth treatment like PRP, LaserCap or Capillus laser therapy, compounded minoxidil Formula 82M, etc. it is verycommon to see a short term shedding phase.
When does shedding after PRP+BioD ECM typically start? Post-PRP shedding typically starts 6 weeks after treatment.
How long does shedding last after PRP+BioD ECM treatment? Post-PRP shedding could last 8-10 weeks.
Shedding can often be concerning for those experiencing hair loss and it is common for patients to call or email their hair doctor or HairCoach during this time describing shedding amounts that are more than double their normal rate per day.
The good news is that when you compare treatment zone HMI (Hair Mass Index) measured with the HairCheck Trichometer at 90 days after the treatment and compare those with the baseline measurements done prior to the treatment, you will nearly ALWAYS see some significant improvement... provided you had PRP with BioD or ACell Extracellular Matrix.
Hair growth improvements as measured with HMI in the treatment area will typically continue to improve for about 9-12 months with PRP+BioD and the plateau may last up to two years. [Bauman AJ - Novel Use of Cryopreserved Amniotic Tissue with PRP for Hair Regrowth - ISHRS Scientific Meeting Chicago Sep 2011] Visually, the area will begin to improve in about 6 months and full results from the treatment will be seen at around 12 months.
Here is my old blog post regarding strong hair regrowth treatments and temporary shedding due to stimulated hair follicle cycling:
Shedding on Minoxidil, Propecia/Finasteride or Laser Therapy
Are you seeing excessive shedding after just beginning hair loss treatment with minoxidil (formula 82m or rogaine), laser therapy (lasercap or other)? You might be having the "Dread Shed!" But don't worry, keep up with the treatment... here's why:
Keep in mind that any regimen (medication or laser therapy) that stimulates follicles to switch into a growth phase can cause shedding. Because all hair follicles cycle-on and cycle-off over the course of your life, shedding is a VERY poor barometer for the measurement of hair loss or hair growth. Regardless of treatment, the more hair follicles you have, the more shedding you will have. "Resting" follicles may still contain a hair-shaft. When you apply minoxidil, for example, and the follicle "switches on" and the newly growing hair pushes out the old, resting hairshaft. The result: a shed. It is my feeling that any hair that is shed from starting a particular therapy wasn't in an anagen/growth phase anyway.
Remember that minoxidil/rogaine is a proven 'anagen-stimulator' which shifts restingfollicles into growing follicles. Female pattern hair loss (androgenetic alopecia) is characterized by miniaturizing follicles and a shortening of the natural growth-phases of the follicles.
Shedding when starting minoxidil, laser, or propecia (if it is noticeable) typically occurs within the first two to eight weeks of therapy. Keep in mind that it normally takes 10-20 weeks for microscopic hair density to peak with minoxidil AND six to twelve months to see visible results of the growth with minoxidil.
BOSTON (CBS) – Scientists at Yale may have discovered quite the off-label use for an FDA-approved arthritis drug.
During a trial which stretched for eight months, a 25-year-old man with almost no hair on his body grew a full head following treatment with the drug. He reported no noticeable side effects.
The patient was suffering from a rare, highly visible disease known as alopecia universalis, which has no cure or approved long term treatment.
The disease causes the loss of almost all body hair.
According to scientists involved in the trial, the patient also grew eyebrows, eyelashes, and facial, armpit, and other hair.
“The results are exactly what we hoped for,” said Brett A. King, M.D., assistant professor of dermatology at Yale University School of Medicine and senior author of a paper reporting the results online June 18 in the Journal of Investigative Dermatology. “This is a huge step forward in the treatment of patients with this condition. While it’s one case, we anticipated the successful treatment of this man based on our current understanding of the disease and the drug. We believe the same results will be duplicated in other patients, and we plan to try.”
The drug, called tofacitinib citrate has also been used successfully for treating psoriasis...
It will be interesting to see if this result can be duplicated in other patients suffering from Alopecia Univeralis! -Dr Bauman