Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 15-005843
NCT ID: NCT02848131
Sponsor Protocol Number: 15-005843
About this study
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.