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Gooch et al. abstract

Please cite this article as follows: Gooch A, Doty J, Flores J, Swenson L, Toegel FE, Reiss GR, Lange C, Zander AR, Hu Z, Poole S, Zhang P and Westenfelder Ch. Initial report on a phase I clinical trial: Prevention and treatment of post-operative Acute Kidney Injury with allogeneic Mesenchymal Stem Cells in patients who require on-pump cardiac surgery. Cell Ther Transplant. 2008;1:e.000028.01. doi:10.3205/ctt-2008-en-000028.01


Initial report on a phase I clinical trial:  Prevention and treatment of post-operative Acute Kidney Injury with allogeneic Mesenchymal Stem Cells in patients who require on-pump cardiac surgery 

Anna Gooch, John Doty, Jean Flores, LeAnne Swenson, Florian E Toegel, George R Reiss, Claudia Lange, Axel R Zander, Zhuma Hu, Scott Poole, Ping Zhang and Christof Westenfelder
Abstract

Based on our extensive pre-clinical data that show that ischemia/reperfusion-induced Acute Kidney Injury (AKI), an essentially treatment resistant complication in patients, can be effectively treated by the administration of allogeneic Mesenchymal Stem Cells (MSC), an FDA approved, Phase I Clinical Trial (www.clinicaltrials.gov; NCT00733876) in patients who are at high risk of developing severe AKI post open heart surgery is currently being conducted. In this safety trial, patients who are undergoing on-pump coronary artery bypass surgery or cardiac valve repair, who are older than 65 years, with underlying renal disease, diabetes mellitus, hypertension, coronary artery disease, congestive heart failure and/or chronic obstructive pulmonary disease will be infused with allogeneic MSC following completion of surgery. The MSC are dosed in an escalating fashion, the initial five patients being infused via a femoral catheter that is placed into the suprarenal aorta with a defined low dose of MSC/kg body weight. This report summarizes the clinical course of the first five patients that have been treated according to this protocol. The renal function did not deteriorate post operatively in any of these patients, nor were adverse (AE) or severe adverse events (SAE) observed to date. However, one patient died suddenly 26 days after discharge from causes that both the principal investigator and the members of the Data and Safety Monitoring Board judged as being unrelated to the study drug and its route of administration. The next group of five study subjects will receive an intermediate dose of MSC/kg body weight, and if no safety concerns arise with this dose, the final five patients will be treated with a high dose of MSC/kg body weight. Preliminary efficacy of MSC therapy in the prevention and treatment of post-operative AKI in this high risk cohort of cardiac surgery patients will be assessed by comparing outcomes in study subjects (frequency, severity and duration of post-operative AKI, dialysis dependency [temporary, permanent], length of stay, and death at 30 days) to those in a large number of historical controls (data base at www.STS.org).

Keywords: acute kidney injury, mesenchymal stem cells, cardiopulmonary bypass pump, open heart surgery

Please cite this article as follows: Gooch A, Doty J, Flores J, Swenson L, Toegel FE, Reiss GR, Lange C, Zander AR, Hu Z, Poole S, Zhang P and Westenfelder Ch. Initial report on a phase I clinical trial: Prevention and treatment of post-operative Acute Kidney Injury with allogeneic Mesenchymal Stem Cells in patients who require on-pump cardiac surgery. Cell Ther Transplant. 2008;1:e.000028.01. doi:10.3205/ctt-2008-en-000028.01

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