Annual Report 2024

Department of Cellular Therapy Processing

Takahiro Fukuda, Wataru Takeda, Tsuneaki Hirakawa, Keiko Irie, Hidetomo Fukumoto, Ryuichi Narita, Terumichi Akiike, Shinpei Hiromatsu, Tetsuro Isobe, Satoshi Hatakeyama, Kenjiro Saito, Tsubasa Hiratsuka, Kotomi Suse, Ryo Ikawa, Sayaka Takeuchi, Noriko Takahashi, Saori Nakabayashi, Maemi Soma, Kyoko Osanai, Kazuya Nakanishi

Introduction

 The Department of Cellular Therapy Processing was established in 2020 as a shared department at the NCCH to respond appropriately to the increasing demand for cellular therapy. We support cell collection, preparation, and storage for hematopoietic stem cell transplantation (HSCT) and newer cellular therapies such as chimeric antigen receptor T-cell (CAR-T) therapy.

The Team and What We Do

 Our department consists of three physicians, eleven clinical engineers, and six medical technologists. In fiscal year 2024 (FY2024), cell collections totaled 12 autologous peripheral blood stem cell (PBSC) harvests, 32 related PBSC harvests, 12 unrelated PBSC harvests, and 3 unrelated bone marrow harvests from Japan Marrow Donor Program (JMDP) donors (Table 1). In the same fiscal year, we performed 27 related peripheral blood stem cell transplantations (PBSCT; including 18 HLA-haploidentical), 25 unrelated PBSCT, 13 cord blood transplantations (CBT), and 13 autologous PBSCT.

Table 1. Number of each type of procedure  

 For CAR-T therapy, we supported three approved products—Kymriah^®, Breyanzi^®, and Yescarta^®—under the national health insurance system. CAR-T therapy was delivered to 48 patients in FY2024.

 For TEMCELL^® (a bone-marrow–derived mesenchymal stem cell product) used to treat steroid-refractory acute graft-versus-host disease (GVHD), we centrally managed storage and preparation; the number of preparations was 75 in FY2024. These activities contributed substantially to the treatment of severe acute GVHD.

Research Activities

 At a national training seminar (JSTMCT 2024), we reported on fundamentals of CD34-positive cell enumeration and workflow refinements for rapid in-process measurement during PBSC collection (presenter: Takahashi).

Clinical Trials

 We were involved in clinical trials of CAR-T therapies; autologous lymphocyte harvests for trials totaled four.

Training and Educational Activities

 We trained certified apheresis nurses from the Japanese Red Cross Society to develop skills in PBSC harvesting and accepted medical technologists from other hospitals for the certified transfusion medicine technologist training program.

Future Prospects

 Along with HSCT, CAR-T therapy is expected to continue increasing. The role of our department will therefore grow further, and we will expand our capacity to ensure timely, appropriate treatment for all patients.