T/GDPHA 001-2023 The clinical technical specifications for transplantation of mesenchymal stem cells into the subarachnoid space for the treatment of traumatic spinal cord injury

Scope

Scope: This document specifies the relevant terms and definitions, basic requirements, risk plans, the formulation of implementation plans, clinical operations of implementation plans, handling of adverse reactions, and follow-up of subjects, etc. This document is applicable to medical institutions and cell preparation institutions that implement subarachnoid transplantation of human mesenchymal stem cells for the treatment of spinal cord injury; Main technical content: This standard specifies the basic principles, overall requirements, technical process, quality control, and safety management of subarachnoid transplantation of human mesenchymal stem cells for the treatment of traumatic spinal cord injury, strengthens the quality control and safety management of clinical operation techniques of human mesenchymal stem cell therapy, standardizes the clinical operation technical process and risk control of human mesenchymal stem cell therapy, and ensures the legitimate rights and safety of subjects.

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