RESTEM is dedicated to approaching significantly unmet medical needs through the development of innovative regenerative medicine therapies that extend and enhance the quality of human life.
We conduct ongoing clinical research to determine, improve, and ensure safety and efficacy in our investigational product candidates. These studies allow us to obtain necessary regulatory authorization in order to release therapies to the general public for those with currently untreatable medical needs.
RESTEM perseveres to ensure the quality and integrity of our trials and minimize risks to research participants and patients. We believe that sustainable, long-term availability of our investigational products can be best achieved by demonstrating safety, tolerability, and effectiveness through the conduct of appropriately authorized and controlled clinical trials designed to address the requirements of regulatory agencies for approval.
We reserve the right to review and amend this policy in the future. If we do amend this policy in the future to provide such expanded access, we are under no obligation to continue to provide such access and may cease at any time.
For additional information about this policy, please contact info@restem.com.
Policy Adopted: July 2020