Expanded Access Policy
Frequency Therapeutics is a clinical-stage biotechnology company focused on developing products to harness the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases. Our approach, called Progenitor Cell Activation (PCA), uses combinations of small molecule drugs to activate progenitor cells within the body to create functional tissue. These products are being developed to address serious conditions and unmet medical need.
Expanded Access refers to the use of an investigational drug outside of a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient who lacks available therapeutic alternatives. Expanded access is different from a clinical trial in which the primary purpose is to collect extensive safety and efficacy data to support submission of an application to the U.S. Food and Drug Administration (FDA) to market a drug.
Frequency Therapeutics understands that some patients may wish to access investigational medicines that are not yet approved by the FDA and other regulatory authorities. The most appropriate way for patients to access our investigational products is by participating in our clinical trials, which are managed by a team of medical experts and are designed to determine whether the investigational products are safe and effective. These clinical studies provide insight to the mechanism of action, safety and efficacy of these products so that the benefits and risks can be adequately understood, and to ensure that quality of life improvements can be considered against any potential adverse effects. The new drug approval process ensures treatments have undergone rigorous evaluation to ensure the benefits outweigh the risks of treatment for the proposed use. Patients who are interested in participating in one of our studies are encouraged to discuss their specific needs with their physician. Information regarding our ongoing clinical trials can be accessed at www.clinicaltrials.gov.
Frequency Therapeutics understands there may be patients interested in obtaining access to our investigational products for treatment under an Expanded Access program. However, at this stage of the development of our products there is insufficient clinical data to support expanded access use and we are unable to manufacture our investigational drugs in the quantities that may be needed for expanded access purposes. Therefore, to ensure availability of materials for clinical trial research and the safety of potential patients, Frequency Therapeutics does not provide access to our investigational products through expanded access currently.
In accordance with the 21st Century Cures Act, this policy may be revised at any time. Should you have additional questions, please reach out to your physician or contact [email protected].