sanostem

  • 1615 South Street, 93304

FDA Grants IND Approval To Stemedica For A Traumatic Brain Injury Phase IIa Clinical Trial

By /

FDA Grants IND Approval To Stemedica For A Traumatic Brain Injury Phase IIa Clinical Trial

SAN DIEGO, California – May 18, 2016. Stemedica received an FDA investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its ischemic tolerant, adult allogeneic mesenchymal stem-cells (itMSC) to treat subjects with traumatic brain injury (TBI). The study is sponsored by Stemedica with ProMedica Health Care Systems of Toledo, Ohio serving as both the trial site and a co-financial supporter of the trial. The clinical trial is titled “A Phase IIa, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells to Subjects with Moderate Traumatic Brain Injury.”

“Stemedica has achieved another milestone by expanding its clinical program in the United States to six major medical indications under IND approval including ischemic stroke, acute myocardial infarction, chronic heart failure, photoaging skin, Alzheimer’s disease and now traumatic brain injury,” said Lev Verkh, Ph.D., Stemedica’s Chief Regulatory & Clinical Development Officer. “We are investigating several medical indications we believe are best suited for our ischemic tolerant mesenchymal stem cells while collecting important safety and preliminary efficacy data on the effects of our stem cells. Our goal is to provide medical options to patients with our product.”

Stemedica’s bone marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing. Stemedica’s itMSCs are manufactured at its government licensed, cGMP (current good manufacturing practices) facility in San Diego, California.

According to the Centers for Disease Control and Prevention (CDC), causes of TBI include falls, motor vehicle crashes, colliding with a person or object and assault. Symptoms of TBI include balance problems; double or blurry vision; sensitivity to light or noise; concentration or memory problems; and mood changes such as irritability, sadness, nervousness and anxiety. In 2010, 2.5 million emergency room visits, hospitalizations or deaths were related to TBI alone, total costs of which exceed $82 billion annually, including medical and work loss costs.

“Stemedica is pleased to be advancing this clinical trial in the investigation of traumatic brain injury,” says Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica. “As the number one cause of death and long-term disability in young people, the prolonged problems it is creating for our military veterans and the pronounced impact it is having on our sports heroes is substantial. Any role our stem cell product can play in aiding those suffering from TBI is worth researching. Along with our partner ProMedica, we are committed to determining the potential role stem cells can play in the treatment of traumatic brain injury.”

The Phase IIa clinical trial will enroll approximately twenty-four (24) patients as part of its study population. Contact research@ProMedica.org for TBI clinical trial information.
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 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.

Forward Looking Statements

This press release may contain forward-looking statements regarding the business strategy of Stemedica’s 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.

Scroll to Top