Compassionate Use Policy

Athersys is committed to addressing areas of significant unmet medical need through the development of innovative regenerative medicine therapies that extend and enhance the quality of human life. We are conducting clinical trials to assess the safety and efficacy of our investigational product candidates, which if proven, will allow us to obtain the approvals from regulatory authorities necessary to provide the broader patient community with access to these therapies where there is often unmet medical need.

We recognize that there are patients with disease indications or related conditions for whom clinical trial enrollment is not an option. These patients may be interested in seeking to utilize our investigational products prior to regulatory approval through expanded access authorization, often referred to as “compassionate use”.

Athersys has ethical responsibilities to ensure the quality and integrity of our clinical trials and to minimize risks to current research participants and future patients. These ethical responsibilities required careful consideration in our evaluation of the appropriateness of providing expanded access to our investigational products. We have concluded 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. Offering expanded access outside of a controlled clinical trial at this time could jeopardize the conduct of our planned clinical or commercial activities, and thus prevent or delay access for other patients in need. Accordingly, we have reached the difficult decision that it is not appropriate to provide expanded access to our investigational products outside of our clinical trials at this time.

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 Responses will be provided within approximately one business week.

Policy Adopted: April 2017