AdiaVita regenerative therapy for chronic kidney disease

Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

This trial tests whether AdiaVita (umbilical cord blood stem cells and exosomes plus glutathione) can improve kidney function in adults with stage 2–4 chronic kidney disease.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Adia Med of Winter Park LLC (other)
• Locations: 1 site (Winter Park, Florida)
• Trial ID: NCT07572890 on ClinicalTrials.gov

What this trial studies

This randomized, single-blind Phase 1 trial enrolls about 100 adults with stage 2–4 CKD and compares three groups: AdiaVita plus glutathione, glutathione with a placebo infusion, and double placebo. Participants receive monthly IV infusions for three months and use a topical glutathione spray at home during the treatment phase, with a crossover option for some participants after the initial phase if safety criteria are met. Primary outcomes are safety and changes in eGFR and serum creatinine, while secondary outcomes track tolerability and adverse events over a total 12-month participation period. Data collection includes laboratory assessments, physical exams, and structured safety monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 with stage 2–4 CKD (eGFR 15–89 mL/min/1.73 m²) who are not on dialysis, can attend regular visits, and are willing to try an experimental therapy.

Not a fit: Patients on dialysis, with a prior kidney transplant, active malignancy, severe uncontrolled medical conditions, or who are immunocompromised or pregnant are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the therapy could improve or stabilize kidney function and potentially delay progression to dialysis for some patients.

How similar studies have performed: Early-phase and small clinical studies of stem cell and exosome approaches in CKD have shown preliminary safety and mixed signals of modest kidney function benefit, but larger definitive trials are still lacking.

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

Exclusion Criteria:

* 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

Where this trial is running

Winter Park, Florida

• Adia Med Of Winter Park — Winter Park, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Evan Thomas, MD, PhD — Adia Med of Winter Park LLC
• Study coordinator: Larry Powalisz

Conditions: Chronic Kidney Disease, Kidney Disease, Kidney Disease, Chronic, CKD, allogeneic stem cells, antioxidant therapy, stem cell therapy, stem cells