Clinical Research

The Research department assists companies with licensing studies for new products and validation studies where new procedures are tested before use in clinical studies. Some of the biomedical companies we collaborate with include: Astellas Gene Therapies (Audentes), Biolog-id, Cellphire, Cerus, CytoSorbents, Fresenius Kabi, Hemanext, Haemonetics, Teleflex, TerumoBCT, MacoPharmaUSA, MEQU, and Velico Medical. 

1. Radioisotope labeling methods for measurement of red cell recovery and survival using chromium-51 and technetium-99m.
2. Radioisotope labeling methods for measurement of platelet recovery and survival using chromium-51 and indium-111.
3. Morphologic and functional tests of red blood cells including: adenosine 5’ triphosphate (ATP), 2,3 diphosphoglycerate (DPG), p50, supernatant hemoglobin, hemolysis, osmotic fragility, blood gases, glucose, sodium, potassium, lactate, morphology, rejuvenation of ATP and 2,3 DPG and flow-cytometric measurement of microparticles (microvesicles), annexin V and phosphotidylserine (PS).
4. Evaluation of leukoreduced products including flow-cytometric, low event leukocyte counting and percent cell loss.
5. Functional platelet test including: morphology, hypotonic shock response (HSR), extent of shape change (ESC), ATP, morphology, aggregation, lactate dehydrogenase and flow-cytometric measurement of CD62-P (P-selectin), annexin V microparticles, thromboelastography (TEG), lactate dehydrogenase (LDH), PS, and circulating platelet specific antibodies.
6. Plasma analysis including: protein and coagulation assays.
7. Evaluation of different automated blood collection systems/technologies.
8. Pathogen reduction studies in blood components.

All studies are reviewed and approved by the Institutional Review Board of the University of Cincinnati Medical Center and Radiation Safety where applicable. Current Good Manufacturing Practices are followed in performance of all procedures, and the laboratory meets the standards of all sponsors as determined by on-site inspections.

1. Cancelas JA, Genthe JR, Stolla M, Rugg N, Bailey SL, Nestheide S, Shaz B, Mack S, Schroeder K, Anani W, Szczepiorkowski ZM, Dumont LJ, Yegneswaran S, Corash L, Mufti N, Benjamin RJ, Erickson AC. Evaluation of amotosalen and UVA pathogen-reduced apheresis platelets after 7-day storage. Transfusion. 2022 Aug;62(8):1619-1629. PMID: 35808974. 
2. Mock DM, Stowell SR, Franco RS, Kyosseva SB, Nalbant D, Schmidt RL, Cres GA, Strauss RG, Cancelas JA, von Goetz M, North AK, Widness JA. Antibodies against biotin-labeled red blood cells can shorten posttransfusion survival. Transfusion 2022 Apr;62(4):770-782. PMID: 35274303 PMC9007277
3. Cancelas JA, Nestheide S, Rugg N, Eckerman A, MacDonald VW, Charles ML, Markstrom L, Atkinson AJ, King MR, Snyder M, Burgess D, Murto J, Valiyaveettil MK, Pehta JC, Penegon SA. Characterization and first-in-human clinical dose-escalation safety evaluation of a next-gen human freeze-dried plasma. Transfusion Feb 2022;62(2)406-17. PMID: 34951486
4.  Kelly K, Cancelas JA, Szczepiorkowski ZM, Dumont DF, Rugg N, Dumont LJ. Frozen platelets - Developmentand future directions. Transfus Med Rev 2020 Oct;34(4)286-93. PMID: 33317698
5. DʼAlessandro A, Yoshida T, Nestheide S, Nemkov T, Stocker S, Stefanoni D, Mohmoud F, Rugg N, Dunham A, Cancelas JA. Hypoxic storage of red blood cells improves metabolism and post-transfusion recovery.Transfusion. 2020 Apr;60(4):786-798. PMID: 32104927 PMC7899235

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For more information please contact Neeta Rugg (Assistant Director, Research) at (513) 558-1525.