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  • Frailty, Inflammation, and Stem Cell Functionality in Chronic Kidney Disease Rochester, Minn.

    As the global epidemic of obesity and diabetes mellitus spreads, an exponential rise in incident chronic kidney disease (CKD) complicated by end stage renal disease (ESRD) is predicted, leaving healthcare systems overwhelmed worldwide. Hence, there is urgent need for novel therapies to slow the progression of DKD and optimize the health of this patient population. The purpose of this study is to examine the effect of a supplement on mesenchymal stem cells, physical body function (or frailty), kidney function, and total clearance of senescent cells in individuals with CKD. At present, we are enrolling participants with CKD, with a subset of participants with diabetic kidney disease (DKD), aged 40-80 years, and eGFR 15-60 mL/min/1.73m2. After screening and enrollment, study participants will be randomized to either the treatment or non-treatment (placebo) arm.  Participants in the treatment arm will take the supplement drug for 2 days.  For all participants, an olive-sized sample of subcutaneous fat will be taken from the abdomen for MSC isolation and repeated at day 14. A frailty assessment along with blood and urine laboratory testing will be done at a total of 3 study visits (enrollment, day 14, and month 4).  Mail-out labs will be accepted for month 12 follow-up. 

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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).

     

  • 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.  

     

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