FDA Approves Trial Testing Stem Cells for Brain Injuries

Gordie Howe (GordieHowe.com)

Updated 10 June 2016. Gordie Howe died today at age 88.

18 May 2016. A company developing stem cell therapies says the U.S. Food and Drug Administration approved its application for a clinical trial testing stem cell treatments for traumatic brain injury. The intermediate-stage trial, sponsored by Stemedica Cell Technologies Inc. is part of a research and educational project on traumatic brain injury, known as the Gordie Howe Initiative, named after the professional ice hockey legend.

The study is co-sponsored by ProMedica Health Care Systems, the site of the trial in Toledo, Ohio. ProMedica is also a co-sponsor of the Gordie Howe Initiative; Murray Howe, one of Gordie Howe’s children, is a radiologist at ProMedica.

Stemedica Cell Technologies in San Diego develops treatments for cardiovascular, neurological, skin, and vision disorders with mesenchymal or adult stem cells. The company says its culturing methods in a low-oxygen environment simulates conditions inside the body, and yields larger quantities of stem cells with consistent quality for therapies. In addition, says Stemedica, its stem cells express more growth factors associated with blood-vessel growth and healing than comparable adult stem cells.

Traumatic brain injuries are caused by a blow to the head or penetrating head wound, such as a gun shot, that disrupt the normal functioning of the brain. The effects can be minor and temporary, such as concussions, but some can cause extended loss of consciousness. Centers for Disease Control and Prevention say 138 people in the U.S. die every day from traumatic brain injuries, accounting for 30 percent of all injury deaths. CDC estimates in 2010, traumatic brain injuries accounted for 2.5 million hospital emergency room visits.

FDA approved the company’s investigational new drug application for the clinical trial. The study will enroll 24 individuals with moderate to severe traumatic brain injury, to test the safety and efficacy of treatments with allogeneic — from unrelated donors — adult stem cells. The stem cells will be derived from bone marrow tissue from healthy volunteers. The first treatments in the study are expected to begin this summer.

Gordie Howe, nicknamed “Mr. Hockey,” had a long and storied professional hockey career, mainly with the Detroit Red Wings in the National Hockey League, and after a two-year retirement, for Houston and New England in the World Hockey Association. Howe played 32 years, up to age 52, winning the Hart Trophy — most valuable player award — in the NHL 6 times, and leading Detroit to 4 Stanley Cup championships.

Howe played in an era when hockey players did not wear helmets. Even with helmets, which began in the 1970s, hockey players are susceptible to concussions, as are participants in other contact sports such as football, rugby, and boxing. The Gordie Howe Initiative expects to raise awareness of traumatic brain injuries, and focus on military veterans and accident victims, as well as athletes.

In 2014, Howe suffered a stroke, and took part in a clinical trial testing Stemedica stem cells as a treatment, which the family says improved his condition.

Read more:

• Challenge Seeks New Regenerative Tools with Stem Cells
• Stem Cell Biotech Licensing Blood Vessel Repair Technology
• Stem Cells Shown to Improve Heart Failure Health Outcomes
• Technique Speeds, Eases Bone Marrow Stem Cell Collection
• Duchenne-Related Stem Cell Heart Therapy Trial Underway

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