Humacyte is a privately held biotechnology company committed to developing and providing innovative and transformative tissue-engineered products to address significant unmet medical needs and significantly improve the quality of life for patients who require vascular surgery. Our initial product is being developed for patients with End Stage Renal Disease who require dialysis.
Humacyte conducts clinical trials to assess the safety and efficacy of its investigational products. The establishment of the safety and efficacy by regulatory agencies such as the FDA is required by law before these investigational products can be made generally available to all patients. Humacyte encourages awareness of — and participation in — clinical trials and believes that participating in clinical trials is the best way for patients to access investigational products prior to regulatory approval.
When it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, physicians may seek expanded access to an investigational product. Expanded access refers to the use of an unapproved investigational product when the primary purpose is to diagnose, monitor, or treat a patient rather than to obtain information about safety and efficacy that is generally derived from clinical trials.
Humacyte has not previously provided unapproved products for expanded access but will consider expanded-access requests case by case. This policy will be reviewed regularly as product development continues, and any changes to the policy will be updated in this location. The following is additional information regarding Humacyte’s expanded access policy in accordance with the 21st Century Cures Act:
If you have any questions regarding Humacyte’s expanded access policy or are interested in participating in a clinical trial, please contact Humacyte at 919-313-9633 x171, or by email at email@example.com.
Procedure for Requesting Expanded Access
The treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly.
We will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient’s health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact.
If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.
If Humacyte decides to make its products available for expanded access in the future, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active.
Humacyte may revise this expanded access policy at any time. Additionally, the posting of this policy by Humacyte shall not serve as a guarantee of access to any specific investigational product by any individual patient.