Adia Med of Winter Park LLC Chronic Kidney Disease Research Study (NCT07572890) | Clinical Trial Compass
RecruitingPhase 1
Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
United States100 participantsStarted 2026-05-18
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial, what does that mean for what's known so far about how safe and effective the treatment is for people with chronic kidney disease like me?
2The study is measuring changes in eGFR and serum creatinine — two key markers of how well my kidneys are working — so how would my doctor and I know if my kidney function is getting better, staying the same, or getting worse during the trial?
3Given that this is an early-phase study still in the recruitment stage, are there standard CKD treatments I should try first before considering enrolling in a Phase 1 research study?
4What monitoring or follow-up appointments would I need to attend as part of this trial, and is the location at Adia Med of Winter Park realistic for my schedule and travel situation?
5If my eGFR continues to decline while I'm participating in this trial, would I be able to stop and switch to a different treatment approach, or could there be any restrictions on my care options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)