Expanded Access Policy
Expanded access, otherwise known as “compassionate use” is a FDA regulated pathway for patients with very serious conditions to gain access to an investigational medical product for treatment outside of a clinical trial. Since Hope Biosciences’ investigational drug, HB-adMSCs, are not yet approved by the FDA, it is considered an investigational medical product.
Access to this pathway is possible if the following conditions are met:
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The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
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Patient enrollment in a clinical trial is not possible
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Potential patient benefit justifies the potential risks of treatment
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Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
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Adequate supply of the investigational drug is available.
Making a Request for Expanded Access:
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Hope Biosciences’ Expanded Access Program is entirely managed by the Hope Biosciences Research Foundation. The patient or authorized representative must make a written request to ea@hopebio.org. The request should include detailed information of the condition and the history of treatment.
Expanded Access Program requests will be responded to within 3 business days. Once a clinical team member is assigned to your case, medical records will be requested to begin the formal review. Upon completion of the review and stem cell banking, the patient will be added to the waitlist.
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The waitlist is prioritized using an algorithm that weighs criteria such as:
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Severity of condition
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Pediatric patient
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Impact on quality of life
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Residence (Domestic patients are prioritized)
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Military status