RepliCel Developing Autologous Cell Therapies For Skin, Hair and Tendon Regeneration

MedicalResearch.com with:

Lee Buckler, CEO
RepliCel Life Sciences

MedicalResearch.com: What is the background for this your company, RepliCel.com?

Response: RepliCel Life Sciences is a Canadian regenerative medicine company based in Vancouver, British Columbia that was founded in 2006. The company focuses on the development of cell therapies using a patient’s own cells (autologous cell therapy). It is developing treatments targeted at healing chronic tendon injuries that have failed to heal properly, hair restoration, and the treatment of damaged and aged skin.

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Topical Cannabinoids May Fight Itch and Inflammatory Skin Diseases

MedicalResearch.com Interview with:
Jessica S. Mounessa, BS

University of Colorado School of Medicine
Aurora, Colorado and
Robert Dellavalle, MD, PhD, MSPH
Professor of Dermatology and Public Health
University of Colorado School of Medicine
Colorado School of Public Health
Chief, Dermatology Service
US Department of Veterans Affairs
Eastern Colorado Health Care System
Denver, CO 80220 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: One in 10 adult cannabis users in the U.S. use it for medicinal purposes. Medicinal cannabis is well studied for its uses in chronic pain, anorexia, and nausea. Numerous recent studies have highlighted other medicinal uses for cannabinoids and related compounds.

We conducted a comprehensive review of the literature on the potential role of cannabinoids in conditions affecting the skin.

Our study reveals the potential benefit of topically prepared cannabinoid compounds, especially for pruritus and eczema.  For example, creams containing Palmitoylethanolamide (PEA), which enhances cannabinoid-receptor binding, have been successful in relieving itch both in the literature, and anecdotally in our clinics.

Though not strictly considered an endocannabinoid, as it does not directly bind to CB1 and CB2 receptors, PEA works by enhancing endocannabinoid binding to these receptors.** Furthermore, the majority of the cannabinoid compounds we studied did not contain psychoactive effects.

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Sonoillumination May Expand Skin Types That Can Be Treated With Laser Therapy

MedicalResearch.com Interview with:

Paul J.D. Whiteside, doctoral candidate and Dr. Heather Hunt, assistant professor of bioengineering University of Missouri

Dr. Heather Hunt and Paul Whiteside

Paul J.D. Whiteside, doctoral candidate and
Dr. Heather Hunt, assistant professor of bioengineering
University of Missouri

MedicalResearch.com: What is the background for this technology? What are the barriers to the use of conventional laser treatment of tattoos?

Response: Traditional laser treatments rely on the concept of selective photothermolysis (laser-induced heating) to specifically target certain structures for treatment, while leaving other parts of the skin unaffected. The problem with traditional laser treatments is that the laser needs to transmit through the epidermis, which acts as a barrier to laser transmission both due to its reflective properties and because it is filled with light-absorbing melanin, the pigment that gives our skin its color. Sonoillumination acts to change the properties of the epidermis temporarily using painless ultrasound technology, thereby allowing more laser light to penetrate deeper into the skin to impact desired targets, such as hair follicles, tattoos, and blood vessels. Funding for clinical trials is currently being sought to provide evidence for what we surmise may be benefits of this technology relative to traditional laser treatments. These benefits may include being able to treat darker-skinned people more effectively, being able to provide laser therapy with less risk of scarring or pigment changes, and being able to do treatments with less discomfort, fewer treatments, and lower laser energy settings.

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Gene Involved in Defective Skin Barrier and Eczema and Ichthyosis Identified

MedicalResearch.com Interview with:

Akio Kihara, PhD. Laboratory of Biochemistry Faculty of Pharmaceutical Sciences, Hokkaido University Sapporo, Japan

Dr. Akio Kihara

Akio Kihara, PhD.
Laboratory of Biochemistry
Faculty of Pharmaceutical Sciences, Hokkaido University
Sapporo, Japan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The skin barrier is the most powerful defensive mechanism terrestrial animals possess against pathogens and harmful substances such as allergens and pollutants. Recent studies indicate that lipids play a central role in skin barrier formation. Multi-lamellar structures consisting of lipids are formed extracellularly in the stratum corneum, the outermost layer of epidermis, and their high hydrophobicity prevents the invasion of external pathogens and compounds.

The stratum corneum-specific lipid acylceramide is especially important for skin barrier formation. Decreases in acylceramide levels are associated with cutaneous disorders such as ichthyosis and atopic dermatitis. However, the mechanism behind acylceramide production is poorly understood, especially regarding the last step of acylceramide production: i.e., esterification of ω-hydroxyceramide with linoleic acid. This means that the broader picture of the molecular mechanisms behind skin barrier formation still remained unclear.

Although PNPLA1 has been identified as an ichthyosis-causative gene, its function in skin barrier formation remains unresolved. In the present study, we revealed that PNPLA1 catalyzes the last step of acylceramide synthesis. Our finding completes our knowledge of the entire pathway of the acylceramide production, providing important insights into the molecular mechanisms of skin barrier formation.

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Smoking Associated With Comorbidities in Atopic Dermatitis

MedicalResearch.com Interview with:

Jacob P. Thyssen MD, PhD, DmSci Department of Dermatology and Allergy Herlev and Gentofte Hospital University of Copenhagen Hellerup, Denmark

Dr. Thyssen

Jacob P. Thyssen MD, PhD, DmSci
Department of Dermatology and Allergy
Herlev and Gentofte Hospital
University of Copenhagen
Hellerup, Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Atopic dermatitis has been associated with various comorbidities. With the emergence of biologics for the treatment of atopic dermatitis, the hypothesis has been raised that atopic dermatitis is a systemic immune disease affecting more than just the skin.

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Immunotherapy Ruxolitinib Cream Improves Facial Vitiligo

MedicalResearch.com Interview with:

David Rosmarin, MD Dermatologist; Assistant Professor Tufts University School of Medicine

Dr. Rosmarin

David Rosmarin, MD
Dermatologist; Assistant Professor
Tufts University School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Vitiligo is a disease where the immune system causes depigmentation of the skin. We performed a pilot study to evaluate the use of a new class of medication for the treatment of vitiligo.


MedicalResearch.com: What should readers take away from your report?

Response: After applying topical ruxolitinib cream twice a day, patients had significant repigmentation, particularly those with facial vitiligo.

This treatment holds promise as a potential new treatment for vitiligo. Because it is a topical, it spares many side effects of taking a medication orally.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Secukinumab Provides Sustained Improvements in Dermatology-Specific Quality of Life in Moderate to Severe Psoriasis Patients Through 3 Years of Treatment

MedicalResearch.com
Eric Hughes
Global Development Franchise Head Immunology & Dermatology
Novartis

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Psoriasis is a chronic immune-mediated inflammatory disease that negatively impacts patients’ quality of life (QOL); therefore QOL outcomes are increasingly recognized as an important measure of efficacy in psoriasis, complementing traditional measures of severity such as the Psoriasis Area and Severity Index (PASI).

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.

Biologic therapies for psoriasis have previously been associated with a fall-off in efficacy over time; accordingly, extended follow-up is required to adequately evaluate novel therapeutic strategies like IL-17A inhibition. Recently, results from the extension of the SCULPTURE secukinumab trial showed that high responses initially achieved with secukinumab at year 1 in the SCULPTURE study were sustained over time up to 3 years with no new or unexpected safety concerns. In this analysis, we examined whether the sustained efficacy observed in SCULPTURE up to 3 years was translated into sustained effect of secukinumab on patient’s QOL measured by the Dermatology Life Quality Index (DLQI) questionnaire.

SCULPTURE, a multi-center extension study, was conducted with subjects who completed 52 weeks of treatment. Subjects were randomized into two maintenance dosing regimens; a fixed-interval schedule of secukinumab 300 mg every 4 weeks (Fixed interval dosing regimen (FI) cohort), and secukinumab retreatment-as-needed (Retreatment as needed (RAN) cohort), in which subjects received placebo until start of relapse, at which time secukinumab 300 mg every 4 weeks was re-initiated.

The analysis using as-observed data showed that at Year 3, improvements in the total score on DLQI was well sustained in both FI and RAN cohorts. Approximately two-thirds of the subjects in the FI cohort reported no impact of skin disease on QOL (corresponding to a score of 0 or 1 on DLQI). The proportion of patients in the RAN cohort reporting no impact of the disease on their QOL was well sustained through 3 years but remained consistently lower than those observed in the FI cohort. The results for each subscale of the DLQI questionnaire were consistent with those with DLQI total score i.e. showing high and sustained proportions of patients reporting no impact of the disease on different domains of health-related QOL in the two secukinumab cohorts with greater effect in the FI cohort compared to the RAN cohort.

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Review of Systemic Immunomodulating Therapies for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

MedicalResearch.com Interview with:
Prof. Dr. Maja Mockenhaupt

Dept. of Dermatology
Medical Center – University of Freiburg
Deutschland / Germany

MedicalResearch.com: What is the background for this study?

Response: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) are severe cutaneous adverse reactions that are associated with high morbidity and mortality. Primarily due to their rareness, therapeutic effects are often studied in observational settings. An evidence-based standardized treatment protocol for SJS/TEN is still missing.
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Safer Immunotherapy Dupilumab (Dupixent) FDA Approved For Atopic Dermatitis

MedicalResearch.com Interview with:

Emma Guttman, MD, PhD Professor, Dermatology, Medicine and Clinical Immunology Vice Chair of Research in the Dermatology Department Director of the center for Excellence  Eczema in the Occupational/Contact Dermatitis clinic  Director of the Laboratory of Inflammatory Skin Diseases Icahn School of Medicine at Mount Sinai Medical Center New York

Dr. Guttman

Emma Guttman, MD, PhD
Professor, Dermatology, Medicine and Clinical Immunology
Vice Chair of Research in the Dermatology Department
Director of the center for Excellence
Eczema in the Occupational/Contact Dermatitis clinic
Director of the Laboratory of Inflammatory Skin Diseases
Icahn School of Medicine at Mount Sinai Medical Center
New York

MedicalResearch.com: Would you briefly explain what is meant by atopic dermatitis? How many people are affected by this disorder?

Response: Atopic dermatitis or eczema as most people know it is an itchy red scaly skin disorder characterized by a very severe itch, that disrupts daily activities, and sleep and severely impairs the quality of life of patients. In the US 30 million people are affected by it, and 1/3 of these we expect to be moderate to severe.

MedicalResearch.com: What is the background for Dupilumab therapy? How does it differ from emollients, steroids or topical immunomodulator treatments for eczema ie Protopic?

Response: The background is that we currently do not have good treatments for long term use for our moderate to severe patients. The only approved drug by the FDA for atopic dermatitis in the US is oral prednisone, that has many long term side effects and causes disease rebound upon discontinuation. Other treatments with many side effects

are broad immune suppressants–Cyclopsorin A, Mycophenolate mofetyl and phototherapy that is not feasible for most patients.

Thus there is a large unmet need for safer and better treatments for moderate to severe atopic dermatitis patients.

Dupilumab is different since it only targets one immune axis–Th2 axis, providing a safer alternative, with high efficacy, that is equal or even better than cyclosporin A, that is the current gold standard immune suppressant, and harbors many side effects including permanent effects on the kidneys after long term use. Topical treatments, while useful for mild patients, are often not adequate or sufficient to control moderate to severe patients that usually have more than 10% body surface area involved and need a systemic treatment.

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Secukinumab (Cosentyx) Provides Greater Improvement in Quality of Life, Work Productivity, and Daily Activity Than Ustekinumab (Stelara) in Moderate To Severe Psoriasis

MedicalResearch.com Interview with:
Eric Hughes, Global Head of Development, Immunology & Dermatology

Novartis Pharma AG
Basel, Switzerland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is well established that psoriasis negatively affects quality of life and work productivity. However, how the treatments affect psoriasis severity (based on skin clearance, itch, pain and scaling symptoms), health-related quality of life (HRQOL), work productivity, and daily activity directly or indirectly (via other factors) are still largely unknown.

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis, and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.

In CLEAR, a Phase 3b head-to-head study versus ustekinumab, secukinumab demonstrated sustained superior efficacy in clearing skin through Week 52, greater improvement in symptoms and HRQOL, greater relief of work and activity limitations, and a comparable safety profile. In this sub-analysis of the CLEAR study, Novartis was interested in examining the relationships among multiple variables that are thought to be important to patients with psoriasis. The direct and indirect (i.e. mediated) effects of treatment (secukinumab or ustekinumab) on psoriasis severity and patients’ HRQOL, work productivity, and daily activity were examined. The evaluation was conducted using structural equation modeling (or path analysis) and compared these relationships for secukinumab versus ustekinumab at 16 and 52 weeks. Structural equation modeling or path analysis is a statistical method that models the direct and indirect relationship between multiple patient-relevant outcomes simultaneously.

Goodness-of-fit statistics for all models were excellent confirming the robustness of the results. Results at Week 16 and at Week 52 for different Psoriasis Area and Severity Index (PASI) response categories (e.g. PASI 75, PASI 90, PASI 100) indicated that psoriasis treatment indirectly affected HRQOL and work productivity and daily activity, measured with the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment (WPAI) questionnaires, respectively.

Actually, greater effect of secukinumab over ustekinumab on DLQI was mediated by greater improvement of secukinumab in PASI response as well as by greater improvement in psoriasis-related symptoms (itch, pain and scaling). Greater effect of secukinumab over ustekinumab on work productivity and daily activity was mediated by greater improvement of secukinumab in psoriasis-related symptoms.

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Number Of High School Students Who Indoor Tan Dropped In Half

MedicalResearch.com Interview with:
Matthew Reynolds
Acting Team Lead, Office of Communication
Division of Cancer Prevention and Control (DCPC)
Centers for Disease Control and Prevention (CDC)
Chamblee GA

MedicalResearch.com: What is the background for this study?

Response: Indoor tanning and sunburns, particularly during adolescence and young adulthood, increases the risk of developing skin cancer. Researchers examined trends in the prevalence of indoor tanning and the relationship between indoor tanning and sunburn among US high school students. Pooled cross-sectional data from the 2009, 2011, 2013, and 2015 national Youth Risk Behavior Surveys. The study included nationally representative samples of U.S. high school students.

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Pediatric Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in the US

MedicalResearch.com Interview with:

Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois

Dr. Jonathan Silverberg

Dr. Jonathan L. Silverberg MD PhD MPH
Assistant Professor in Dermatology
Medical Social Sciences and Preventive Medicine
Northwestern University, Chicago, Illinois

MedicalResearch.com: What is the background for this study?

Response: Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (SJS/TEN) are relatively rare and potentially life-threatening disorders. There have been some recent advances in our understanding of the epidemiology and risk factors of SJS/TEN in adults.

However, little is known about the epidemiology of pediatric SJS/TEN.

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