Analysis of Adverse Events Related to 720 Cases of Neural Progenitor Cell Transplantation

Abstract

Background: Cell therapies have shown to be able to improve neurological functions to some extent for patients with refractory central nervous system (CNS) diseases or damages. Meanwhile, increasing attention has been drawn to the operation-related and (or) cell-related adverse events when performing cell therapy. Our study is to explore the safety issue from 720 cases of neural progenitor cell (NPC) transplantation based on clinic manifestations and examinations.

Method: A retrospective analysis of all adverse events associated with 720 cases of NPC transplantation by administering the cells into the ventricles was done.

Results: One hundred and sixty-six cases had postoperative crying and irritability, 69 with vomiting and 84 with fever. None of them had CNS infection, but 4 cases presented intracranial hemorrhage. One month after cell therapy, 568 cases did EEG test, in which 153 patients showed improvement, 74 had abnormal changes in and 341 cases had no changes in; two patients developed new-onset convulsions and 3 had recurrent convulsions; 6 cases had intracranial hemorrhage, but no other CNS sequelae left from the primary diseases. 180 patients were able to follow-up for their clinical evaluation and head MRI or CT examination 2 years after transplantation. All patients didn't show signs of tumorigenesis and no serious and irreversible operation- or cell-related adverse events.

In conclusion: there are mild adverse reactions and reversible adverse events following cell transplantation, our study indicated that NPC transplantation is a safe therapy in clinical treatment. Further clinical trials are necessary to establish the safety of this therapy.

Keywords: Adverse event; child; neural progenitor cell; retrospective analysis; transplantation.