Developing Practice Guidelines for Preparation and Infusion of Cellular Therapy Products

Document Type

Conference Proceeding

Publication Date

2-2024

Publication Title

Transplantation and Cellular Therapy

Abstract

Topic Significance & Study Purpose/Background/Rationale: Cellular therapy staff have historically relied on expert opinion, accreditation standards and manufacturer recommendations, to guide cellular therapy infusion (CTI) practices. The foundation for these practice recommendations were based on the first infusions of cellular therapy products; very little has changed over time, despite improvements in donor selection, product processing, and outcome analysis. Through discussions in the Nursing Track sessions at the American Society for Transplantation and Cellular Therapy (ASTCT) meetings, a lack of evidence surrounding CTI was identified. A focus group was established to explore the current evidence, identify gaps, and draft guidelines for preparation and infusion of CTI. Methods, Intervention, & Analysis: At the 2018 ASTCT annual meeting, the Nursing Special Interest Group (SIG) distributed a survey regarding center specific CTI clinical practice, to Nursing Track registrants. One hundred and five nurses responded, outlining their CTI institutional practice. Practice variations were clearly present. The results catalyzed members of the Nursing SIG to embark on a project to develop nurse-centric CTI practice guidelines. The 2020 COVID pandemic impacted progress, but at each annual meeting, the survey was repeated with similar inconsistent practices. In 2022, ASTCT practice guidelines committee approved the project; and in 2023, a committee was developed assuring representation from large, mid and small, adult and pediatric cellular therapy centers. The group utilized the survey questions, professional networking platforms, and questions submitted by individuals within the working group. By September 2023, the teams had completed responses to queries within the following categories: product preparation, patient preparation, infusion procedure, complications, and training. Findings & Interpretation: There is limited empirical evidence for many practices, contributing to the variability reported in the surveys. From the available literature, accreditation/regulatory and industry recommendations, the group identified rationale for over 20 frequently asked questions. The group is currently in the final editing stages and organizing the findings for publication. Discussion & Implications: After review of the literature, this appears to be the first attempt in developing practice guidelines for CTI (with exception for cord blood units). Findings have elucidated the need for future research and consensus for these specialized procedures. This guideline can be utilized to guide policy development for existing and new centers.

Volume

30

Issue

2 Suppl

First Page

S71

Comments

2024 Tandem Meeting of ASTCT (American Society for Transplantation and Cellular Therapy) and CIBMTR (Center for International Blood and Bone Marrow Research), February 21-24, 2024, San Antonio, TX

Last Page

S72

DOI

10.1016/j.jtct.2023.12.115

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