StemCyte Inc.

Single-Patient EA Policies/Criteria 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. Available Therapies via Single-Patient EA Post-COVID syndrome