Longitudinal Study Reveals Critical Timeframe for PBMC Stability in Clinical Trials

Dr. Kurt Sales Presents Groundbreaking Findings at WRIB Conference

Recently Dr. Kurt Sales, the Chief Scientific Officer of Agilex, presented on the state of immunology studies in multicenter clinical trials at the 17th WRIB conference. His poster, poster presentation entitled “Longitudinal Study: Impact of Processing Time on PBMC Stability, Viability, Composition, and Function,” shed light on the challenges of maintaining sample integrity and processing time in multicenter clinical trials.

The Significance of PBMCs in Immunology Studies

PBMCs, or peripheral blood mononuclear cells, play a vital role in determining the immunological impact of drugs in clinical trials. These cells, comprising T-cells, B-cells, monocytes, macrophages, and dendritic cells, are isolated from patients’ blood samples and used to assess the drug’s effect on the immune system. While fresh whole blood is preferred for assays, logistical challenges often necessitate the use of PBMCs as an alternative.

Dr. Sales and his team conducted a longitudinal study involving healthy volunteers to determine the window of viability for PBMCs. Blood samples were obtained from three volunteers and PBMCs were isolated at different time intervals—0 hours (immediately), 24 hours, 48 hours, and 72 hours post-blood draw. The viability of the cells was assessed using a dying cell counter, and frozen samples were also thawed after a week to assess long-term impact.

The study revealed a critical timeframe for PBMC viability. After 24 hours, there was a dramatic decline in cell viability, resulting in a concomitant loss of functionality. B-cells, NK cells, monocytes, macrophages, and dendritic cells showed rapid deterioration, leaving only T-cells as viable entities. This finding has significant implications for clinical trial settings where transit time may extend beyond the optimal viability window.

Relevance for Sponsors and CROs

Sponsors and contract research organizations (CROs) involved in multicenter trials or those with phase one units located outside of Australia can benefit immensely from Dr. Sales’ study. The research offers valuable insights into refining clinical trial packages and optimizing the collection and processing of PBMC samples. Sponsors in the fields of immunomodulatory drugs, cell and gene therapy, and immuno-oncology, in particular, stand to gain a deeper understanding of the viability limitations of different cell types and can tailor their study designs accordingly. Dr. Kurt Sales’ poster presentation at WRIB has provided groundbreaking insights into the stability and viability of PBMCs in immunology studies. Agilex invites all interested parties, including sponsors and CROs in the immunomodulatory drug field, to reach out for a copy of the poster presentation. By engaging in a conversation with Agilex, you can explore how these findings can be applied to your specific project, ensuring the integrity of your clinical trial data and optimizing the use of PBMCs. Contact Dr. Kurt Sales today to start a conversation that could shape the future of your clinical research.

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