NCT00818597 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klöhr S, Koball S, Stange J, Ringel B, Nebe B, Schmidt H, Podbielski A, Noeldge-Schomburg G, Schmidt R
Use of human preconditioned phagocytes for extracorporeal immune support: introduction of a concept. Ther Apher. 2001 Oct;5(5):423-32.
Sauer M, Altrichter J, Kreutzer HJ, Lögters T, Scholz M, Nöldge-Schomburg G, Schmidt R, Mitzner SR
Extracorporeal cell therapy with granulocytes in a pig model of Gram-positive sepsis. Crit Care Med. 2009 Feb;37(2):606-13. doi: 10.1097/CCM.0b013e318194aa77.

PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study

Clinical trial NCT00818597 - References