NCT07572890RecruitingPhase 1
Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 1 May 2026
- Start date
- 18 May 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Adia Med of Winter Park LLC
- Diseases
- Chronic kidney disease
- NCT number
- NCT07572890
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 100
- From 18 May 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion
- 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
Other illness
- Severe allergies to study products
- Significant uncontrolled medical conditions
- Malignancy history
Other
- Has
- Immunocompromised
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Adia Med Of Winter Park Coordinator of this site? Confirm its status | Winter Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.