Policy & Regulation
Patient Enrollment Begins in Third and Final Cohort of the Phase 2 MATRICS-1 Clinical Study Evaluating Athersys' MultiStem Following Hemorrhagic Trauma
5 June 2023 - - US-based regenerative medicine company Athersys, Inc. (NASDAQ: ATHX), which is developing MultiStem (invimestrocel) cell therapy for critical care indications, said that patient enrollment has begun in the third and final cohort in MATRICS-1, the Phase 2 clinical study evaluating MultiStem in patients following resuscitation from hemorrhagic trauma.

This study is being conducted at The University of Texas Health Science Center at Houston (UTHealth Houston) and Memorial Hermann-Texas Medical Center, a leading certified Level One Trauma Center, and approximately 140 patients will be enrolled in cohort three.

MATRICS-1 is supported in part by MTEC (Medical Technology Enterprise Consortium) in partnership with the Department of Defense, and funding from Memorial Hermann Foundation.

Patients in the third cohort will be dosed with MultiStem cells produced under Athersys' novel 3D bioreactor-based manufacturing process, a process that was first utilized to produce product for patients in cohort two of MATRICS-1.

MultiStem is believed to deliver benefit for treating complications due to trauma through mechanisms including reducing inflammatory damage, protecting at-risk tissue at the site of injury and upregulating reparative aspects of the local and systemic immune system in a more timely way.

The MATRICS-1 double-blind, placebo-controlled Phase 2 study is evaluating the safety and effectiveness of MultiStem for the prevention and early treatment of complications after severe traumatic injury.

The study is enrolling severely injured trauma patients who have survived initial treatment and are admitted to the intensive care unit, where they are randomized to receive MultiStem or placebo within hours of hospitalization, along with standard of care.

MultiStem (invimestrocel) cell therapy is a patented regenerative medicine product in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage.

MultiStem therapy's potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit.

The therapy represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression.

Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent tolerability demonstrated in clinical studies, the company believes that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

Established in 1972 by The University of Texas System board of Regents, The University of Texas Health Science Center at Houston (UTHealth Houston) is Houston's Health University and Texas' resource for health care education, innovation, scientific discovery and excellence in patient care.

The most comprehensive academic health center in the UT System and the US Gulf Coast region, UTHealth Houston is home to Jane and Robert Cizik School of Nursing, John P. and Kathrine G. McGovern Medical School, D. Bradley McWilliams School of Biomedical Informatics, and schools of biomedical sciences, dentistry, and public health.

UTHealth Houston includes the UTHealth Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UTHealth Neurosciences, UT Dentists, and UT Health Services.

The university's primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children's Memorial Hermann Hospital, and Harris Health Lyndon B. Johnson Hospital.

Memorial Hermann Health System owns and operates 14 hospitals and has joint ventures with three other hospital facilities, including Memorial Hermann Surgical Hospital First Colony, Memorial Hermann Surgical Hospital Kingwood and Memorial Hermann Rehabilitation Hospital-Katy.

Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates.

The company is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product.

Athersys has forged strategic partnerships and a broad network of collaborations to further advance MultiStem cell therapy toward commercialization.