SAN DIEGO, CALIFORNIA (PRWEB) October 16, 2015
StemCutis, LLC., a subsidiary of Stemedica Cell Technologies, Inc., has enrolled the first cohort of three subjects in its Phase I/II clinical trial for subjects with cutaneous photoaging. The study is entitled "A Phase I/II, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects for Cutaneous Photoaging." It is the first clinical trial in the U.S. to use allogeneic stem cells systemically for the treatment of photoaged skin. Curt Littler, MD, a board-certified dermatologist, is the Principal Investigator of the study.
StemCutis develops dermatological therapies using human allogeneic stem cells, and over-the-counter (OTC) skin care products derived from the stem cells.
"The unique design of this clinical trial combines low-dose Fraxel laser treatment on the face with a single intravenous infusion of stem cells in the subject's arm," states Dr. Littler. "The administration of low-dose Fraxel laser is expected to create minor inflammation in the facial skin, which is intended to facilitate homing of the stem cells to the face after a single intravenous infusion of Stemedica-manufactured stem cells."
Ronald G. Wheeland, MD, FACP, past chair of dermatology at the University of California, Davis, University of New Mexico, and the University of Arizona as well as a former President of the American Academy of Dermatology comments, "The innovation here is a systemic, rather than local, treatment for repair of the underlying pathophysiology of photoaged skin. For years, the treatment of cutaneous photoaging consisted largely of repeat application of caustic acids to the skin surface, sanding the skin surface (known as dermabrasion) or destroying the sun-damaged skin using lasers or intense light. All of these techniques were painful and required prolonged post-operative wound care to maximize healing.
"Now, the StemCutis clinical trial examines whether the therapy prevents, stops or reverses the pathophysiology of skin-aging through systemic augmentation of cell-derived 'healing factors.' The potential outcome would be improvement in the quality, health and appearance of the skin through restoration of normal physiology with minimal downtime and post-operative care."
Nikolai Tankovich, MD, PhD, Founder and Chairman of StemCutis states, "Almost everyone over the age of 40 has a certain level of photoaged skin. The Phase I portion of this study enrolls subjects at sequentially higher doses to establish a safe dose in otherwise healthy persons. Based on a review of the Phase I data by an independent Data Safety Monitoring Board (DSMB), 20 additional subjects will be treated in the Phase II portion of this study at the dose considered safe by the DSMB. In addition to extensive and frequent safety monitoring over one year following each subject's study treatment, a preliminary evaluation of efficacy will be performed on the appearance of facial wrinkles and in improvements in biomarkers that signal the skin's aging process."
This study is being conducted under U.S. FDA Investigational New Drug (IND) #15061 and will recruit approximately 30 subjects at eStudySite in La Mesa, California. More information about this clinical trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT01771679?term=STemCutis&rank=1.
StemCutis's therapies are dermatological applications of ischemia-tolerant mesenchymal stem cells (itMSCs). The technology is exclusively licensed from StemCutis's parent company, Stemedica. Unlike other MSCs, Stemedica's bone marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic (5% oxygen) conditions which improves homing and engraftment of the cells compared to MSCs grown under higher oxygen concentrations. itMSCs secrete a unique profile of stem cell factors and other important proteins. The Stemedica-manufactured stem cells are currently used in clinical trials of a single intravenous infusion for the treatment of stroke or heart failure patients under U.S. INDs.
Founded in San Diego, California in 2014, StemCutis, LLC., is a global biotechnology company that develops stem cell-based therapies and products for dermatological applications. StemCutis therapies are based on the unique, proprietary technologies for the expansion of cells under hypoxic conditions, which provides critical benefits for safety, efficacy, scalability, and standardization. StemCutis has exclusive, worldwide licenses and rights from Stemedica and other related companies to develop and market the products for a range of conditions that affect skin and tissue appearance and function, such as compromised skin, hair loss, burns, and hypertrophic, atrophic, and keloid scars, as well as other skin conditions. For more information, visit http://www.stemcutis.com.
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