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NCT07572890 · ClinicalTrials.gov registry record · Phase 1
Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
A Phase 1 study, sponsored by Adia Med of Winter Park.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT07572890 is a Phase 1 study that is actively recruiting participants, run by Adia Med of Winter Park. The registered enrollment target is 100 participants.
The verdict
NCT07572890, a Phase 1 study, is actively recruiting participants, sponsored by Adia Med of Winter Park.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
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.
Interventions
- BIOLOGICAL Umbilical Cord Blood-Derived Stem Cells and Exosomes
- OTHER Placebo IV
- DRUG Glutathione IV
- DRUG Glutathione Spray
- OTHER Placebo Glutathione IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-05-18 |
| Est. Completion | 2029-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07572890
The ClinicalTrials.gov registry entry for NCT07572890 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adia Med of Winter Park, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Umbilical Cord Blood-Derived Stem Cells and Exosomes is the first listed.
NCT07572890 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07572890 about?
NCT07572890 is a clinical study titled "Adia Med of Winter Park LLC Chronic Kidney Disease Research 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...
What is the current status of trial NCT07572890?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2026-05-18. Estimated completion is 2029-01.
What interventions are being tested in trial NCT07572890?
The interventions under investigation include: Umbilical Cord Blood-Derived Stem Cells and Exosomes (BIOLOGICAL), Placebo IV (OTHER), Glutathione IV (DRUG), Glutathione Spray (DRUG), Placebo Glutathione IV (OTHER).
Who is sponsoring clinical trial NCT07572890?
This trial is sponsored by Adia Med of Winter Park, which has 3 total clinical trials registered on ClinicalTrials.gov.
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