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Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Age 18-80 years * Confirmed CKD diagnosis (eGFR 15-89 mL/min/1.73 m²) * Willingness to consider experimental treatments and comply with study requirements * Ability to obtain required bloodwork * Ability to attend all scheduled visits * Able to meet study cost requirements ($15,000 study fee) as described in the informed consent Exclusion Criteria: * Has * Severe allergies to study products * Significant uncontrolled medical conditions * Immunocompromised * Malignancy history * Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion * Current dialysis (hemodialysis or peritoneal dialysis) or planned initiation of dialysis during the study period * Pregnancy or breastfeeding (if applicable) * Participation in another interventional trial within 30 days * Has had Kidney transplant * Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening
About the study
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.
What is being tested
- Umbilical Cord Blood-Derived Stem Cells and Exosomes (biological)
- Glutathione IV (drug)
- Glutathione Spray (drug)
- Placebo IV (other)
- Placebo Glutathione IV (other)
- Placebo Spray (other)
Sponsor: Adia Med of Winter Park LLC · Participants: 100 · Started: May 18, 2026
Contact the study team
- Larry Powalisz · Phone: 3217880850
Official record on ClinicalTrials.gov — NCT07572890
Locations in the U.S.
| Florida | Adia Med Of Winter Park, Winter Park |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.