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Clinical Studies

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  • Allogeneic Mesenchymal Stem Cell Therapy in Patients with Chronic Kidney Disease: A Phase I Study (AMSCs CKD) Jacksonville, Fla.

    The purpose of this study is to assess the safety, tolerability, optimal dosing, effectiveness signals reflecting kidney repair, and markers of mesenchymal stem cells (MSC) function that relate to response to allogenenic adipose tissue-derived MSC in patients with Chronic Kidney Disease (CKD).

     

  • Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease (BM-MSC For CKD) Jacksonville, Fla. The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease.
  • Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease Rochester, Minn.

    The purpose of this study is to assess the safety and tolerability of intra-arterially delivered mesenchymal stem/stromal cells (MSC) to a single kidney in one of two fixed doses at two time points in patients with progressive diabetic kidney disease. 

    Diabetic kidney disease, also known as diabetic nephropathy, is the most common cause of chronic kidney disease and end-stage kidney failure requiring dialysis or kidney transplantation.  Regenerative, cell-based therapy applying MSCs holds promise to delay the progression of kidney disease in individuals with diabetes mellitus.  Our clinical trial will use MSCs processed from each study participant to test the ability of these cells to help repair kidney damages caused by diabetes.  Fat will be collected from the abdomen to produce the MSCs. A few months after the fat is collected, participants will then receive the stem cells into the kidney artery at two time points (Day 0 and Month 3). Participation in the trial will include approximately 4 on-site visits at Mayo Clinic in Rochester, Minnesota.  Some visits will require an overnight stay in the Clinical Research and Trials Unit. Several tests will be completed to assess the response to the stem cells, including two magnetic resonance imaging (MRI) scans. Participants will be followed for a total of 15 months after the first dose of stem cells are administered.  

     

  • Stem Cells in Chronic Kidney Disease (CKD): Understanding functional characteristics of mesenchymal stem cells and endothelial progenitor cells in CKD Rochester, Minn.

    New treatments of the future may use stem cells, cells that naturally occur in our blood or belly/abdominal fat, to help people with kidney disease.  The purpose of this study is to understand the function of specific cell types and how well they may work to repair our kidneys.  Two cell groups, mesenchymal stem cells (MSCs) and endothelial progenitor cells (EPCs), will be examined.  Study participants will include individuals with varying degrees of kidney function and potential causes of kidney disease.  This information will help plan for future studies using stem cells to treat kidney disease.

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