AdiaVita regenerative therapy for chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Adia Med Of Winter Park
  Winter Park, Florida, United States Recruiting

Study contacts

• Principal investigator: Richard Edwards, DO — Adia Med of Winter Park LLC
• Study coordinator: Larry Powalisz
• Email: research@adiamed.com
• Phone: 3217880850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.