Compassionate Use Policy (Expanded Access)

Spinogenix understands that patients who do not qualify for clinical trials may seek access to investigational therapies. In certain cases, we may provide access to our investigational products outside of clinical trials through compassionate use, also known as Expanded Access Programs (EAP).

Eligibility:

  • U.S.A.
  • The patient has a serious or life-threatening condition for which no satisfactory treatment options are available.
  • The patient is not eligible to participate in a clinical trial for the investigational therapy, either due to geographic limitations or because the trial is no longer enrolling.

Request Process:

Compassionate use requests can only be submitted by a licensed physician on behalf of a patient. To submit a request, the physician at an approved clinical trial site should provide relevant medical history and justification for the need for access to the investigational therapy.

Contact:

For more information or to submit a request, please contact us at
contact@spinogenix.com. We will respond to all requests as quickly as possible.

Additional Information:

Please note that compassionate use may be limited by the availability of the investigational product and ongoing clinical trials. More information about Spinogenix’s clinical trials can be found at clinicaltrials.gov.