Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

Summary

The goal of this clinical trial is to learn whether a new regenerative treatment called AdiaVita, made from umbilical cord blood-derived stem cells and exosomes combined with glutathione, is safe and can help improve kidney function in adults with chronic kidney disease (CKD). In this condition, the kidneys gradually lose their ability to filter blood as well as they should. The main questions it aims to answer are whether AdiaVita plus glutathione improves kidney function better than control treatments, as measured by blood tests for estimated glomerular filtration rate (eGFR) and creatinine levels, and whether the treatment is safe with acceptable side effects. Researchers will compare three groups. One group will receive AdiaVita plus glutathione. A second group will receive glutathione plus a placebo for AdiaVita. The third group will receive placebos for both treatments. A placebo looks like the real treatment but contains no active ingredients. This will help determine if the full treatment works better than the controls. Approximately 100 adults aged 18 to 80 with stage 2 to 4 chronic kidney disease may participate. Participants will be randomly assigned to one of the three treatment groups. They will receive monthly intravenous infusions at the clinic for the first three months and apply a skin spray twice daily at home during that period. The study lasts 12 months total for each participant, with regular visits for blood tests, physical exams, and safety monitoring. Certain participants in the control groups may switch to the active AdiaVita treatment after three months if they meet safety criteria. This is a single-blind study, meaning participants will not know which treatment they receive. Participant safety is closely monitored by the research team and an independent board throughout the study.

Detailed Description

This study evaluates the safety and preliminary efficacy of a regenerative therapy combined with glutathione in adults with chronic kidney disease. The primary objective is to determine whether the treatment improves kidney function as measured by estimated glomerular filtration rate and serum creatinine levels. Secondary objectives focus on assessing safety, tolerability, and the incidence of adverse events. The study is designed as a randomized, single-blind, controlled trial with three treatment arms. Participants include approximately 100 adults aged 18 to 80 diagnosed with stage 2-4 chronic kidney disease. Subjects are recruited through clinical sites, outreach efforts, and partnerships with healthcare providers. Participants are randomly assigned to receive either the investigational therapy with glutathione, an active control, or a full placebo. The intervention consists of monthly intravenous infusions over a three-month initial treatment period. At-home administration of a topical spray is also required during the treatment phase. A crossover option allows certain participants to receive the investigational therapy after the initial phase if safety criteria are met. The total study duration per participant is 12 months, including treatment and follow-up. Data collection includes laboratory assessments, physical exams, and monitoring of adverse events. Safety oversight is provided through structured monitoring procedures and an independent review board. Risks include infusion-related reactions, allergic responses, and unknown long-term effects. Potential benefits include improved kidney function and contributions to scientific knowledge. All data are securely stored and analyzed, with confidentiality maintained and results reported in a de identified manner. No monetary incentives are offered, and Patient instead pay a fixed fee of $15,000 for Phase One, which covers all procedures and includes crossover if applicable. Outcomes will contribute to scientific knowledge regarding the safety and possible clinical utility of stem cell-based therapies for CKD.

Eligibility Criteria

Interventions