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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: Cerus Corporation; MacoPharmaUSA; Haemonetics Corporation;and TerumoBCT Biotechnologies 

Expertise:

  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), 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), and annexin V.
  4. Evaluation of leukoreduced products including flow-cytometric, low event leukocyte counting and percent cell loss.
  5. Morphologic and functional platelet test including: hypotonic shock response, extent of shape change, morphology, aggregation, lactate dehydrogenase and flow-cytometric measurement of CD62-P (P-selectin), annexin V and microparticles.
  6. Plasma analysis including: protein and coagulation assays.
  7. Evaluation of different automated blood collection systems/technologies.
  8. Pathogen reduction studies in blood components.

Compliance:

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.


Selected Publications:

1. A randomized controlled trial evaluating recovery and survival of 6% dimethyl sulfoxide-frozen autologous platelets in healthy volunteers. Dumont LJ, Cancelas JA, Dumont DF, Siegel AH, Szczepiorkowski ZM, Rugg R, Pratt PG, Worsham DN, Hartman EL, Dunn SK, O’Leary M, Ransom JH, Michael RA, Macdonald VW. Transfusion 2013 Jan;53(1):128-37.

2. In vitro and in vivo quality of leukocyte-reduced apheresis platelets stored in a new platelet additive solution. Dumont LJ*, Cancelas JA*, Graminske S, Friedman KD, Vassallo RR, Whitley PH, Rugg N, Dumont DF, Herschel L, Siegal AH, Szczepiorkowski ZM, Fender L, Razatos A. Transfusion 2013, May;53(5):972-80.

3. Stored red blood cell viability is maintained after treatment with a second generation S-303 pathogen inactivation process. Cancelas JA, Dumont LJ, Rugg N, Szczepiorkowski ZM, Herschel L, Siegel A, Pratt PG, Worsham DN, Erickson A, Propst M, North A, Sherman CD, Mufti NA, Reed WF, Corash L. Transfusion 2011 Nov;51(11):2367-76.

4. Infusion of P-Capt prion filtered red cell products demonstrate acceptable in vivo viability and no evidence of neoantigen formation. Cancelas JA, Rugg N, Pratt PG, Worsham DN, Pehta JC, Banks K, Davenport RD, Judd WJ. Transfusion 2011 Oct;51(10):2228-36.

5. In vivo viability of stored red blood cells derived from riboflavin plus ultraviolet light-treated whole blood. Cancelas JA, Rugg N, Fletcher D, Pratt, PG, Worsham DN, Dunn SK, Marschner S, Reddy HL, Goodrich RP. Transfusion 2011 Jul;51(7):1460-8.

View Recent Publications

For more information please contact Neeta Rugg at (513) 558-1525.