Policy
Patient Eligibility Criteria:
To be eligible for accessing to the investigational product, patients must meet following criteria:
• The patient 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 benefits 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 profiles.
• 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-specific 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: Sct_pCOV01@stemcyte.com.tw. We will do our best efforts to acknowledge each submitted request within 5 business days.
As authorized by the 21st Century Cures Act, StemCyte may revise this expanded access policy at any time. Additionally, the posting of this policy by StemCyte shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
Patient Eligibility Criteria:
Expanded
Access Policy
Background
StemCyte has been a global leader in seeking new treatments using umbilical cord blood and newborn stem cells. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug.
Food, Drug, and Cosmetic Act for provision of such a drug. Our compassionate use, also known as expanded access policy, consists of an expanded access program, single patient emergency IND (eIND), and single patient expanded access. The following is StemCyte’s expanded access, also known as compassionate use, policy for drugs that are intended to treat serious diseases.