Expanded Access Policy

Expanded Access Policy for Joseph D. Allen Cellular Medicine Center's iPSC-Derived Specialized Cell Therapy

At Joseph D. Allen Cellular Medicine Center, we are committed to providing access to our investigational iPSC-derived specialized cell therapy for patients with serious or life-threatening conditions who lack viable treatment alternatives. We recognize the importance of the FDA's Expanded Access Program in facilitating access to promising investigational products outside of clinical trials.

Eligibility Criteria
We will consider requests for expanded access to our iPSC-derived specialized cell therapy if the following criteria are met:

• The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative treatment options available.

• The potential benefits of receiving the investigational therapy justify the potential risks to the patient.

• Providing the investigational therapy will not interfere with the clinical development or regulatory approval process.

• The treating physician is qualified and willing to oversee the expanded access use.

Approval Process
All requests for expanded access to our iPSC-derived specialized cell therapy must be submitted by the treating physician using our Expanded Access Request Form, which can be accessed on our website at [link].

The request will be reviewed by a committee consisting of three of our company directors: a PhD in a non-medical scientific field, an MD clinician, and a Biomedical Engineer. This committee will evaluate each request on a case-by-case basis, considering the eligibility criteria as well as the available safety and efficacy data for the investigational therapy.

We will make every effort to provide a decision on the expanded access request within 30 days of receiving a complete submission. If approved, we will work closely with the treating physician to facilitate access to the investigational therapy, subject to product availability and any other logistical considerations.

It is important to note that approval of an expanded access request is not guaranteed, as each case will be evaluated individually. We reserve the right to deny a request or withdraw permission for expanded access if new safety or efficacy data emerges that could impact the risk-benefit assessment.

For any questions or to submit an Expanded Access Request, please contact our Patient Affairs team at [email address].