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Mononuclear cell recruitment during extracorporeal photopheresis: Partial results of a phase 1/2 randomized clinical
Yandy Marx Castillo-Aleman1, Carlos Agustin Villegas-Valverde1, Yendry Ventura-Carmenate1
1Abu Dhabi Stem Cells Center (ADSCC), 25, Mahdar Qutouf St., PO Box 4600, Rowdhat, Abu Dhabi, United Arab Emirates.
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.
Insights
Extracorporeal photopheresis (ECP) demonstrates intra-apheresis recruitment (IAR) of mononuclear cells (MNCs) in multiple sclerosis patients, even with low initial counts. This recruitment enhances cell collection efficiency during ECP treatments.
Area of Science:
- Immunology
- Cellular Biology
- Medical Technology
Background:
- Routine extracorporeal photopheresis (ECP) use lacks detailed investigation into mononuclear cell (MNC) dynamics during treatment.
- Understanding intra-apheresis dynamics is crucial, especially for patients with initially low MNC counts.
Purpose of the Study:
- To investigate and verify the phenomenon of intra-apheresis recruitment (IAR) of MNCs during ECP.
- To assess the clinical utility of IAR in optimizing ECP for patients with suboptimal pre-apheresis MNC levels.
Main Methods:
- Prospective analysis of ECP procedures from the PHOMS study (NCT05168384) involving multiple sclerosis (MS) patients.
- Utilized the Therakos® CellEx® Photopheresis System.
- Calculated recruitment factor (RF), collection efficiency 1 (CE1), and fold enrichment (FE) for MNCs, lymphocytes, monocytes, and neutrophils.
Main Results:
- Intra-apheresis recruitment (IAR) of MNCs, lymphocytes, and monocytes was observed in over 88% of analyzed ECP procedures.
- Collection efficiency (CE1) exceeded 100% for MNCs, lymphocytes, and monocytes in a significant portion of ECPs.
- Fold enrichment (FE) for MNCs and lymphocytes was consistently high (≥1 in all procedures), and for monocytes (≥97.8%). Positive correlations were found between RF, CE1, and FE, indicating improved collection quality.
Conclusions:
- ECP is feasible and safe even with suboptimal MNC counts, without exacerbating cytopenias.
- Sustained intra-apheresis recruitment (IAR) of MNCs is a consistent finding in MS patients undergoing ECP.
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