Study of AdiaVita Stem Cell and Glutathione Treatment for Adults with Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating a new regenerative treatment called AdiaVita, which combines umbilical cord blood-derived stem cells and exosomes with glutathione, to see if it is safe and can improve kidney function in adults with chronic kidney disease CKD. This condition involves a gradual loss of the kidneys ability to filter blood properly. The study compares the effects of AdiaVita plus glutathione to glutathione with a placebo and to a full placebo, aiming to measure changes in kidney function and monitor safety and side effects. Approximately 100 adults aged 18 to 80 with stage 2 to 4 CKD are expected to participate in this single-blind, randomized trial. Participants will be randomly assigned to one of three groups one receives AdiaVita plus glutathione, another glutathione plus placebo for AdiaVita, and the third group receives placebos for both treatments. The intervention involves monthly intravenous infusions at the clinic for the first three months and twice-daily application of a skin spray at home during this period. After three months, some participants in the control groups may switch to the AdiaVita treatment if safety criteria are met. The total study duration is 12 months for each participant, including treatment and follow-up. Throughout the study, participants will attend regular visits for blood tests, physical exams, and safety monitoring. Researchers will measure kidney function using blood tests for estimated glomerular filtration rate eGFR and serum creatinine levels. They will also track any adverse events and evaluate safety over the 12-month period. Participant safety is closely monitored by the research team and an independent board. All data are securely stored and analyzed to contribute knowledge on stem cell-based therapies for CKD.

Adia Med of Winter Park LLC Chronic Kidney Disease Research Study