Source: September 28; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the safety, tolerability and clinical effects of Stemedyne-MSC (Stemedica’s human bone marrowderived ischemia tolerant mesenchymal cells) in subjects with cutaneous photoaging resulting from overexposure to ultraviolet radiation.
Curt M. Littler, M.D., F.A.A.D., dermatologist at Sharp ReesStealy Medical Group, Inc., is the principal investigator of the study. Dr. Littler commented, "This study is an important step forward in the field of dermatology. Photoaging is a universal condition. Damage from the sun’s rays alters the skin’s underlying structures, such as collagen, elastin, and blood vessels, and contributes to the creation of abnormal epidermal cells, which can become precancerous. By administering stem cells systemically, this study has the potential to target skin damage throughout the body and promises to pave the way for new treatment approaches for photoaged skin."
The IND approval allows Stemedica to initiate a clinical trial at medical centers within the United States. The clinical trial will be a Phase I/IIa multicenter open-label study involving 3035 subjects with significant cutaneous photodamage.
"The FDA’s approval of Stemedica’s IND for the treatment of photoaging with our StemedyneMSCs is a significant milestone not only for Stemedica, but for the whole skin healthcare industry," said Nikolai Tankovich, M.D., Ph.D., Stemedica’s President and Chief Medical Officer. "This is the first clinical trial approved for the systemic treatment of aging skin utilizing intravenous administration of stem cells". Dr. Tankovich added "Our internal organ health is reflected in the appearance of our skin. In this clinical trial, we will be following systemic indicators such as liver panel and kidney function. We are encouraged that the FDA acknowledges cutaneous photoaging as a medical indication and that potential treatments should be regulated as a drug."
Lev Verkh, Ph.D., Stemedica’s Chief Regulatory and Clinical Development Officer, commented, "With photoaging, we lose certain proteins that affect the health and appearance of our skin. For the first time in a clinical trial we can address the underlying biological changes of the skin to slow down this process and repair the changes of aging."
StemedyneMSC is one of the three adult allogeneic adult stem cell products developed by the Company. Other products include StemedyneNSC neural human stem cells and StemedyneRPE retinal progenitor epithelial cells available in early 2013. All Stemedica products are unique in their ability to tolerate ischemic conditions.
About Stemedica Cell Technologies, Inc. Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of bestinclass allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for preclinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trial for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The company is headquartered in San Diego, California.
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