Post-COVID syndrome
Describe your company's single-patient EA policies and criteria.
Patient Eligibility Criteria:
To be eligible for accessing to the investigational product, patients must meet following criteria:
• Has a serious or life-threatening condition with no satisfactory alternative.
• Ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations.
• Did not receive any cell-based therapy within 1 year.
• Assessment that benefi ts outweigh the risks to the patient.
• Must agree to comply with all study requirements and be willing to complete all study visits.
Investigational Product Criteria:
• The product is under clinical investigation in one or more clinical trials, with high safety profi les.
• Assessment that the company has an adequate supply of the investigational product.
• A determination that expanded access will not interfere with the company's ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients.
Treating Physician Criteria and Responsibility:
The physician must agree in writing to comply with:
• Physician(s) is (are) properly licensed.
• Physician(s) meet the applicable country-specifi c legal and regulatory requirements related to providing the investigational products under the Expanded Access.
• Physician(s) must be experienced and familiar in cord blood or stem cell infusion.
• Any StemCyte’s requirements in terms of safety reporting and protection of intellectual properties.
• A treating physician may submit questions and requests regarding to the Expanded Access to email: expandedaccess@stemcyte.com. We will do our best efforts to acknowledge each submitted request within 10 business days.