Expanded Access Program
1. To submit a request for an investigational medicine outside of a clinical trial, the treating physician can contact us here.
Email: info@xenotx.org with the Subject Line: (EXPANDED ACCESS realSKIN)
Phone: 617-939-7892
2. XenoTherapeutics may consider such requests on a case-by-case basis when contacted directly (see above).
3. The conditions below are required:
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The investigational drug is under active clinical development but is not yet approved by the FDA
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The patient is ineligible for or otherwise unable to participate in clinical trials
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The potential benefit to the patient should outweigh potential risks
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No other comparable or satisfactory alternative therapy
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Serious or immediately life-threatening disease or condition
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Providing drug will not compromise product development
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The request for investigational drug comes from a licensed physician
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The requested product is not marketed for another indication
4. We will get back to you within 5-7 business days acknowledging receipt of such request.
5. Here is the link to our clinical trial record containing information about expanded access for realSKIN as required under section 282(j)(2)(A)(ii)(II)(gg) of title 42: NCT03695939
At XenoTherapeutics, we’re committed to discovering and developing regenerative medicines treat serious and chronic conditions. Sometimes, patients or healthcare providers may wish to access investigational medicines that are not yet approved by the U.S. Food and Drug Administration (FDA).
The most appropriate way patients could access these medications is through our clinical trials. Overseen by a team of medical experts, clinical trials are designed to determine whether an investigational medicine is safe and effective for patients.
In cases where enrolling in a clinical trial is not possible, there are options such as expanded access. The criteria for these options are based on regulations enabling this type of access.