Real-World Evidence Data on Adverse Reactions to Infusion of Thawed Hematopoietic Progenitor Cells: Retrospective Analysis from a Single Center in India

Introduction Adverse reactions (ARs) occur during infusion of thawed hematopoietic progenitor cells (HPCs) either due to infusion or its contents. There is sparse literature on it in the world and none in India. Therefore, we retrospectively analyzed ARs occurring during and within 1 hour of infusion of thawed HPCs. Materials and Methods This study was done in a tertiary-care center, between 2019 and 2022. Data collected included age, gender, diagnosis, specifications of contents of infusion product (volume of product, volume of dimethyl sulfoxide per kg body weight, total nucleated cell count per microliter, and viability of CD 34+ cells), pretreatment given, and ARs, if any from the procedure records and the hospital information system. Results The present study included 55 transplant patients, and the commonest diagnosis was Hodgkin lymphoma. All were prophylactically hydrated and premedicated as per institutional protocol. AR was seen in 56.36% (n = 31); the commonest type of ARs was nausea (n = 26) followed by vomiting (n = 13), abdominal pain (n = 4), shivering (n = 3), transient tachycardia (n = 2), transient hypotension (n = 2), and hematuria (n = 1). All ARs were managed clinically by giving symptomatic treatment. No patients required intensive care, and there were no deaths or aborted procedures. Characteristics of infusion products had no significant correlation to ARs. Discussion To the best of the author's knowledge, this is the first such study from India. We report an overall incidence of ARs of 56.36%, which is similar to the previously published data on ARs during thawed HPC infusions. AR is a common occurrence and can be managed medically and symptomatically.