SAN DIEGO, CALIFORNIA – February 29, 2016 – StemCutis, LLC, a subsidiary of Stemedica Cell Technologies, Inc., today announced the addition of the Naval Medical Center San Diego (NMCSD) as a second site for the Phase II portion of its clinical trial for subjects with cutaneous photoaging, a skin condition caused by chronic ultraviolet radiation (UVA and UVB) sun exposure. 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.”
The unique design of this clinical trial combines low-dose fractional resurfacing laser (Fraxel®) treatment on the face with a single intravenous infusion of non-embryonic adult human mesenchymal bone marrow stem cells. The administration of the low-dose laser energy creates minor inflammatory injury 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.
Ike Lee, PhD, President and CEO of StemCutis stated, “We are pleased to be working with the Naval Medical Center San Diego. We hope the results from this clinical trial will provide early evidence of the role allogeneic adult stem cells can play in treating sun damage caused by chronic UVA and UVB exposure.”
The study is being conducted through a Cooperative Research and Development Agreement (CRADA) between StemCutis and the NMCSD. By entering into this CRADA, NMCSD does not directly or indirectly endorse any product or service provided, or to be provided, by StemCutis, its successors, assignees, or licensees. StemCutis is contributing doses of the unique, investigational, human-origin mesenchymal bone marrow stem cells and will have the right to exclusively license the new technology developed from the collaboration. .
Commander John Paul Trafeli, Medical Corps, U.S. Navy, Board Certified Dermatologist, will be the Principal Investigator at the NMCSD. According to Dr. Trafeli, “Skin damage from excessive sun exposure is a problem for military personal, particularly over the past two decades with prolonged deployments to the desert areas. We are excited to be involved in this pioneering systemic allogeneic stem cell infusion study for treatment of photoaged skin.” He added, “It is the first of its kind, not only for the Navy, but also for the United States Military. With this collaboration, we see tremendous potential to expand future stem cell research in many medical specialties that are of great importance to the military.”
Nikolai Tankovich, M.D., Ph.D. is the President and Chief Medical Officer of Stemedica. He noted, “This is a systemic rather than local treatment for repair of the underlying pathophysiology of photoaged skin. For years, skin treatments for cutaneous photoaging have been painful involving application of caustic acids, or the use of dermabrasion, lasers or intense light, all of which often require prolonged wound healing. StemCutis’ clinical trial examines whether the therapy prevents, stops or reverses the pathophysiology of aging skin through systemic augmentation of cell-derived ‘healing factors.’” In addition, Dr. Tankovich stated, “Potential outcomes include improvement in the quality, health and appearance of the skin through restoration of normal physiology with minimal recovery time and post-treatment care.”
The Phase II portion of this study is being conducted under U.S. FDA Investigational New Drug (IND) #15061 and will recruit approximately 30 subjects at the NMCSD and at eStudySite in La Mesa, California. The NMCSD Institutional Review Board (IRB) approved the human subjects’ research at NMCSD; Western IRB approved the La Mesa study site. More information about this clinical trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT01771679.
In addition to extensive and frequent safety monitoring for one year after each subject’s study treatment, a preliminary evaluation of efficacy will be performed on the appearance of facial wrinkles along with improvements in biomarkers that signal the skin’s aging process.
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 have been used in clinical trials for the treatment of stroke and chronic heart failure patients under U.S. INDs.
About StemCutis, LLC
Founded in San Diego, California in 2014, StemCutis, LLC, is a global biotechnology company that develops stem cell-based dermatological therapies and over-the-counter (OTC) skin care 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 Stemedica-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, among others. For more information, visit www.stemcutis.com.
About Stemedica Cell Technologies Inc.
Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that manufactures best-in-class, allogeneic, adult stem cells and stem cell-derived factors. The company is a government-licensed manufacturer of cGMP, clinical-grade stem cells currently used in clinical trials in the United States under FDA Investigational New Drug (IND) approval for chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used by research institutions and hospitals outside of US under the auspices of international regulatory authorities for pre-clinical and clinical (human) trials. Stemedica is developing clinical trials for other indications using its adult, allogeneic stem cells. The company has headquarters in San Diego, California, and can be found online at www.stemedica.com.
Forward Looking Statements
This press release may contain forward-looking statements regarding the business strategy of Stemedica Cell Technologies, Inc. and its subsidiaries (“Stemedica”), including statements regarding Stemedica’s future clinical studies and planned regulatory activities. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity or performance to differ materially from those expressed or implied by these forward looking statements. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.