体外光再生过程中的单核细胞募集：多发性硬化症1/2期随机临床试验的部分结果

IF 1.4 4区医学 Q4 HEMATOLOGY

Transfusion and Apheresis Science Pub Date : 2025-02-09 DOI:10.1016/j.transci.2025.104095

Yandy Marx Castillo-Aleman , Carlos Agustin Villegas-Valverde , Yendry Ventura-Carmenate , Fatema Mohammed Al-Kaabi , Shinnette Lumame , Charisma Castelo , Ruqqia Mir , Lev Brylev , Mutaz Atieh , Muhammad Touseef Haider , Antonio Alfonso Bencomo-Hernandez

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引用次数: 0

摘要

尽管体外光造血（ECP）在过去的几十年里被常规应用于临床，但对单核细胞（MNCs）的体外光造血动力学还没有充分的研究。目的本研究旨在验证跨国公司的“采回内招募”（IAR），这在采回前跨国公司计数低的情况下可能特别有用。方法分析PHOMS研究（NCT05168384）背景下多发性硬化症（MS）患者ECP手术的前瞻性数据。使用Therakos®CellEx®光化学系统进行ECPs，并根据批准的方案在不同时间间隔计算MNCs、淋巴细胞、单核细胞和中性粒细胞的募集因子（RF）、收集效率1 （CE1）和折叠富集（FE）。结果本研究共对9例MS患者进行了252次ECP手术，并分析了45次ECP的数据。在93.3% %、95.5% %和88.8% %的ECP过程中，观察到MNCs、淋巴细胞和单核细胞的IAR （RF≥1）。这些人群在13.3% %、11.1 %和24.4% %的ECPs中CE1超过100 %，而在所有ECPs中MNCs和淋巴细胞中发现FE≥ 1，单核细胞中发现FE≥97.8% %。此外,积极与CE1射频相关跨国公司(r = 0.40,p = 0.006)和淋巴细胞(r = 0.43,p = 0.003),以及与铁单核细胞(r = 0.39,p = 0.01)和淋巴细胞(r = 0.48,p = 0.001),进一步提高采集质量。结论MNC计数不理想的情况下进行光疗是可行的，并不会加重预期的细胞减少。此外，我们的研究结果显示，在接受ECP的MS患者中，MNCs持续IAR。

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Mononuclear cell recruitment during extracorporeal photopheresis: Partial results of a phase 1/2 randomized clinical trial in multiple sclerosis

Background

Despite the routine clinical use of extracorporeal photopheresis (ECP) for the last decades, there has been no sufficient investigation on the intra-apheresis dynamics of mononuclear cells (MNCs).

Objective

This research aims to verify the "intra-apheresis recruitment" (IAR) of MNCs, which may be particularly useful in cases with low preapheresis MNC counts.

Methods

Prospective data of ECP procedures for patients with multiple sclerosis (MS) in the context of the PHOMS study (NCT05168384) were analyzed. ECPs were performed with the use of the Therakos® CellEx® Photopheresis System, and the recruitment factor (RF), collection efficiency 1 (CE₁), and fold enrichment (FE) for MNCs, lymphocytes, monocytes, and neutrophils were calculated at various intervals per the approved protocol.

Results

A total of 252 ECP procedures were performed on nine patients with MS, and data from 45 ECPs were analyzed for this study. IAR (RF ≥ 1) of MNCs, lymphocytes, and monocytes was observed in the 93.3 %, 95.5 %, and 88.8 % of the ECP procedures, respectively. CE₁ exceeded 100 % for these populations in 13.3 %, 11.1 %, and 24.4 % of ECPs, while FE ≥ 1 for MNCs and lymphocytes was found in all ECPs, and in 97.8 % of ECPs for monocytes. Additionally, RF correlated positively with CE₁ for MNCs (r = 0.40, p = 0.006) and lymphocytes (r = 0.43, p = 0.003), as well as with FE for monocytes (r = 0.39, p = 0.01) and lymphocytes (r = 0.48, p = 0.001), further improving collection quality.

Conclusions

Administering photopheresis with suboptimal MNC counts was plausible and did not worsen the anticipated cytopenias. Moreover, our findings revealed sustained IAR of MNCs in patients with MS who underwent ECP.

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来源期刊

Transfusion and Apheresis Science 医学-血液学

CiteScore

3.60

自引率

5.30%

发文量

181

审稿时长

42 days

期刊介绍： Transfusion and Apheresis Science brings comprehensive and up-to-date information to physicians and health care professionals involved in the rapidly changing fields of transfusion medicine, hemostasis and apheresis. The journal presents original articles relating to scientific and clinical studies in the areas of immunohematology, transfusion practice, bleeding and thrombotic disorders and both therapeutic and donor apheresis including hematopoietic stem cells. Topics covered include the collection and processing of blood, compatibility testing and guidelines for the use of blood products, as well as screening for and transmission of blood-borne diseases. All areas of apheresis - therapeutic and collection - are also addressed. We would like to specifically encourage allied health professionals in this area to submit manuscripts that relate to improved patient and donor care, technical aspects and educational issues. Transfusion and Apheresis Science features a "Theme" section which includes, in each issue, a group of papers designed to review a specific topic of current importance in transfusion and hemostasis for the discussion of topical issues specific to apheresis and focuses on the operators'' viewpoint. Another section is "What''s Happening" which provides informal reporting of activities in the field. In addition, brief case reports and Letters to the Editor, as well as reviews of meetings and events of general interest, and a listing of recent patents make the journal a complete source of information for practitioners of transfusion, hemostasis and apheresis science. Immediate dissemination of important information is ensured by the commitment of Transfusion and Apheresis Science to rapid publication of both symposia and submitted papers.