A Phase 1 interventional study of Umbilical Cord Blood-Derived Stem Cells and Exosomes and Glutathione IV in Chronic Kidney Disease, Kidney Disease and Kidney Disease, Chronic, sponsored by Adia Med of Winter Park LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Adia Med of Winter Park LLC · Phase 1, Interventional, and Treatment
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.
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.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 100 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
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Exclusion Criteria:
Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes · Drug: Glutathione IV · Drug: Glutathione Spray
Drug: Glutathione IV · Other: Placebo IV · Other: Placebo Spray
Other: Placebo IV · Other: Placebo Glutathione IV · Other: Placebo Spray
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
Transdermal glutathione spray (4 sprays applied twice daily to the skin).
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.
Matched placebo transdermal spray (4 sprays applied twice daily).
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in eGFR (mL/min/1.73 m²)
Time frame: Baseline to Month 6
Change from Baseline in Serum Creatinine
Change from baseline in serum creatinine level (mg/dL)
Time frame: Baseline to Month 6
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Number and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) in each treatment arm
Time frame: From first infusion through Month 12
Change from Crossover Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita
Time frame: Month 3 to Month 9 (crossover participants only)
Change from Crossover Baseline in Serum Creatinine
Change in serum creatinine from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita
Time frame: Month 3 to Month 9 (crossover participants only)
Plan to share: No — No, we do not plan on sharing IPD data with other researchers.
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Adia Med of Winter Park LLC