Filter results

Clinical Studies

Open

  • Hematopoietic Stem Cell Transplant Survivors Study (HTSS Study) (HTSS) Rochester, Minn.

    The investigators hope to find the proof of principle concept from this pilot study so that the investigators can design a clinical trial based on the results of the explanatory hypothesis.

  • 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.  

     

  • Senescence, Frailty, and Mesenchymal Stem Cell Functionality in Chronic Kidney Disease: Effect of Senolytic Agents Rochester, Minn.

    Trials applying stem cells for the treatment of diabetic kidney disease (DKD) will soon be under way.  Autologous (from the patient) over allogeneic transplantation is the preferred option.  However, success with cellular therapy in DKD patients may be limited by a frailty phenotype and “unhealthy” stem cells due to cellular senescence.  The purpose of this study is to examine the effect of two drugs on mesenchymal stem cells, physical body function (or frailty), kidney function, and total clearance of senescent cells. Information from these investigations will help design preconditioning protocols for clinical trials applying stem cells for the treatment of DKD. 

    At present, we are enrolling participants with DKD, aged 40-80 years, and eGFR 15-45 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 2 drugs for 3 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. 

  • 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.

Contact Us for the Latest Status

  • 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. 

.