Expanded Access Policy
Celularity Inc. (“we” or “Celularity”) is committed to developing safe and effective therapies for the broadest range of patients and providing access to those therapies as quickly as possible. To do this, Celularity conducts clinical trials to allow us to better understand the safety and efficacy of our products and obtain the necessary regulatory approvals.
Participation in clinical trials is the best way for a patient to access our investigational products prior to approval. However, we understand that this is not always possible, especially for patients suffering from life-threating diseases or conditions that may require special access to investigation therapies outside of a clinical trial setting. Our compassionate use program provides a pathway for patients to access our investigational products outside of our clinical trials where no alternative therapy options are available.
Treating physicians can make are request for expanded access use of Celularity’s investigational products by contacting Expanded.Access@celularity.com. Upon receipt, an acknowledgment will be provided and Medical professionals at Celularity who are familiar with the data collected on our investigational products will evaluate each request to ensure the following criteria are met:
- Sufficient evidence of the safety and effectiveness of the investigational product is available to support its use in the particular indication, in an environment less controlled than a clinical trial.
- The probable risk to the patient from the investigational product is shown to be not greater than the probable risk from the disease or condition.
- There is no comparable or satisfactory therapy (approved or investigational) available to treat the patient’s disease or condition.
- The patient is unable to participate in a clinical trial based on the trial’s inclusion and exclusion criteria, or if participation in the study is not geographically feasible.
- Product supply is available to support compassionate use in addition to any ongoing clinical study supply needs.
- The request is made by a patient’s treating physician, who must agree to comply with the Celularity’s safety and monitoring requirements.
- The patient provides informed consent regarding the risks associated with taking the investigational product.
- The patient agrees to provide access to their data for use by Celularity in support of product development activities.
- Providing investigational products does not delay progression of the clinical development and the ultimate goal to provide broad patient access to approved, safe and effective products.
If the above criteria are not met, Celularity will only be able to offer our investigational products to patients participating in controlled clinical studies. Please check www.ClinicalTrials.gov for ongoing clinical studies.
It is important to keep in mind that the potential risks and benefits of an investigational product may not have been fully established. Accordingly, Celularity makes no representations or warranties that its investigational products eligible for expanded access use are safe or effective for any purpose. Patients and their treating physician should consider all possible benefits and risks when seeking expanded access use to an investigational product.