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In major news released today, Stemedica announced that it is beginning clinical trials in the Unites States using allogeneic human mesenchymal stem cells (MSCs) to treat Alzheimer’s Disease. This Phase IIa clinical study is a major advance toward the use of cell-based solutions to address degenerative brain conditions.
Stemedica International S.A. is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells.
Clinical trial to study the effects of Stemedica’s proprietary mesenchymal stem cells in patients with traumatic brain injury.
SAN DIEGO, California; May 18, 2016 — Stemedica Cell Technologies, Inc. (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.” [Read more…]
Hockey Legend Gordie Howe and Allies from Sports, Military and Scientific Communities unite for The Gordie Howe Initiative with ProMedica and Stemedica Cell Technologies
TOLEDO, Ohio, May 11, 2016 –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.
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 atwww.stemedica.com.
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.
Media Contacts:
ProMedica
Tedra White
419-469-3864 (O)
419-262-0371 (C)
[email protected]
Stemedica
Hank Handtmann
858-658-0910 ext. 7226 (O)
805-895-5505 (C)
[email protected]
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.
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In major news released today, CardioCell, LLC, annnounced that it had completed enrollment for its Phase IIa chronic heart failure (HF) clinical trial.
The Phase IIa study protocol delivers ischemia-tolerant mesenchymal stem cells (itMSCs) via intravenous infusion to participants with non-ischemic cardiomyopathy. CardioCell’s itMSCs are exclusively licensed from its parent company, Stemedica.
Complete details for the clinical trials can be viewed at: http://clinicaltrials.gov/ct2/show/NCT02123706.
To learn more, view the full press release issued by CardioCell, LLC, below. [Read more…]
The mesenchymal stem cell industry is well-known for its shifting dynamics, including new alliances, new research advances and innovations. Every month there are major new events that affect market participants.
While it may be possible to stay informed about mesenchymal stem cell industry news in your region, it can be more difficult to track changes on a global scale. For that reason, the following is a summary of significant mesenchymal stem cell industry events for June 2015.
