Unique Coalition To Launch Human Stem Cell Trial For Traumatic Brain Injury

TOLEDO, Ohio, May 11, 2016 /PRNewswire/ -- Toledo-based ProMedica and San Diego-based Stemedica Cell Technologies, Inc. ("Stemedica"), along with the family of hockey legend Gordie Howe, announced plans today to collaborate on research to advance the treatment of traumatic brain injury (TBI).

The three-year effort will be known as The Gordie Howe Initiative to support clinical research and increase awareness about TBI with an initial focus on war veterans, athletes and automobile accident victims. Several well-known sports figures, members of the scientific community and military officials are lending their support to this initiative including Briana Scurry, two-time Olympic goalkeeper and Women's World Cup Champion, and Joseph Maroon, MD, team neurosurgeon for the Pittsburgh Steelers.

The first stage of the initiative will include a U.S.-based Phase IIa clinical trial to evaluate preliminary safety and efficacy of Stemedica's proprietary allogeneic mesenchymal stem cells ("MSCs") in patients with moderate to severe TBI. Twenty four patients will be enrolled in the initial clinical trial to be conducted at ProMedica Toledo Hospital.

"There is encouraging preliminary evidence that stem cells may have a positive impact on enhancing the quality of life for individuals with TBI," said Lee Hammerling, MD, ProMedica chief medical officer. "We are optimistic about the potential of this research and look forward to working in partnership with Stemedica and other agencies, entities and concerned individuals to form a coalition for advancing potential solutions for TBI."

The clinical trial has been designed, and is supported by, a nine-member, nationally-recognized scientific advisory board which will supervise all aspects of the clinical research. The stem cells used in this study are derived from bone marrow tissue obtained from a healthy adult volunteer through a government-licensed bone marrow donation program and grown by Stemedica in a low oxygen, ischemic environment. The MSCs are manufactured by Stemedica at its government-licensed, cGMP facility in San Diego. Stemedica's MSCs are also being used in five other U.S. Food and Drug Administration-approved clinical trials under Investigative New Drug (IND) status.  

In addition to clinical trial activities, The Gordie Howe Initiative will work with other TBI-focused organizations to raise awareness for, and provide educational outreach on, what role emerging technologies can play in treating TBI.

"We are delighted to be working with ProMedica and the Gordie Howe family in advancing this initiative," said Maynard A. Howe, PhD, Stemedica vice chairman and chief executive officer. "Together, through collaboration, innovation and inspiration, we have the opportunity to make significant advancements in traumatic brain injury research at a human level. This unique and dynamic partnership model will allow us to attract the resources we need in order to accelerate possible opportunities for those in need."

According to the Centers for Disease Control and Prevention, TBI impacts an estimated 1.7 million Americans each year and is a leading cause of death and disability. Effects of TBI may include impaired thinking or memory, movement, sensation (e.g., vision or hearing), or emotional functioning (e.g., personality changes, depression and behavioral problems). TBI and its effects have recently gained significant notoriety from returning military veterans and professional athletes playing contact sports such as football, soccer and hockey.

Nicknamed "Mr. Hockey," Gordie Howe is considered one of the greatest hockey players in history and continues to hold National Hockey League records for the most games and seasons played. After suffering a stroke in 2014, Howe participated in a clinical trial utilizing Stemedica's stem cell products which resulted in significant improvement of his medical condition as reported by his family. 

"Our family is deeply honored to have this initiative named after our father," said Murray Howe, MD, ProMedica radiologist. "My father was a leader on the ice and it is a privilege for him to continue that legacy by supporting this initiative."

The Gordie Howe Initiative anticipates enrolling its first clinical trial patients this summer.

About Stemedica

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 the U.S. under the auspices of international regulatory authorities for pre-clinical and clinical (human) trials. The company is headquartered in San Diego, California, and can be found online at www.stemedica.com.

About ProMedica

ProMedica is a mission-based, not-for-profit healthcare organization serving northwest Ohio and southeast Michigan. The 13-hospital system has more than 17,000 employees, 2,300 physicians with privileges, and more than 800 healthcare providers employed by ProMedica Physicians. Additionally it offers a health plan, Paramount, which serves 320,000 members including more than 225,000 members in the statewide Medicaid plan. Driven by its Mission to improve your health and well-being, ProMedica offers a full range of diagnostic, medical and surgical specialties in areas such as emergency medicine and trauma, behavioral health, heart and vascular, oncology, orthopedics, neurology, and women's and children's services. The health system has been nationally recognized for its advocacy programs and efforts to raise awareness about hunger as a health issue. For more information about ProMedica, please visit www.promedica.org/aboutus.

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SOURCE Stemedica Cell Technologies, Inc.

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