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 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; CKD; Kidney Disease, Chronic; Kidney Disease; Chronic Kidney Disease (CKD)
• Intervention / Treatment: Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Drug: Glutathione IV; Drug: Glutathione Spray; Other: Placebo IV; Other: Placebo Spray; Other: Placebo Glutathione IV

Detailed Description

This study evaluates the safety and preliminary efficacy of a regenerative therapy combined with glutathione in adults with chronic kidney disease. The primary objective is to determine whether the treatment improves kidney function as measured by estimated glomerular filtration rate and serum creatinine levels. Secondary objectives focus on assessing safety, tolerability, and the incidence of adverse events. The study is designed as a randomized, single-blind, controlled trial with three treatment arms. Participants include approximately 100 adults aged 18 to 80 diagnosed with stage 2-4 chronic kidney disease. Subjects are recruited through clinical sites, outreach efforts, and partnerships with healthcare providers. Participants are randomly assigned to receive either the investigational therapy with glutathione, an active control, or a full placebo. The intervention consists of monthly intravenous infusions over a three-month initial treatment period. At-home administration of a topical spray is also required during the treatment phase. A crossover option allows certain participants to receive the investigational therapy after the initial phase if safety criteria are met. The total study duration per participant is 12 months, including treatment and follow-up. Data collection includes laboratory assessments, physical exams, and monitoring of adverse events. Safety oversight is provided through structured monitoring procedures and an independent review board. Risks include infusion-related reactions, allergic responses, and unknown long-term effects. Potential benefits include improved kidney function and contributions to scientific knowledge. All data are securely stored and analyzed, with confidentiality maintained and results reported in a de identified manner. No monetary incentives are offered, and Patient instead pay a fixed fee of $15,000 for Phase One, which covers all procedures and includes crossover if applicable. Outcomes will contribute to scientific knowledge regarding the safety and possible clinical utility of stem cell-based therapies for CKD.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Larry Powalisz; Phone Number: 3212312843; Email: ceo@adiamed.com

Study Locations

• United States
  • Florida
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Adia Med Of Winter Park
      • Contact: Larry Powalisz; Phone Number: 3212312843; Email: ceo@adiamed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stem Cell + Glutathione	Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.; Drug: Glutathione IV; Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule); Drug: Glutathione Spray; Transdermal glutathione spray (4 sprays applied twice daily to the skin).
Active Comparator: Glutathione Control (with Crossover)	Drug: Glutathione IV; Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule); Other: Placebo IV; Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).; Other: Placebo Spray; Matched placebo transdermal spray (4 sprays applied twice daily).
Placebo Comparator: Placebo Control (with Crossover)	Other: Placebo IV; Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).; Other: Placebo Spray; Matched placebo transdermal spray (4 sprays applied twice daily).; Other: Placebo Glutathione IV; Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)	Change from baseline in eGFR (mL/min/1.73 m²)	Baseline to Month 6
Change from Baseline in Serum Creatinine	Change from baseline in serum creatinine level (mg/dL)	Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events	Number and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) in each treatment arm	From first infusion through Month 12
Change from Crossover Baseline in Estimated Glomerular Filtration Rate (eGFR)	Change in eGFR from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita	Month 3 to Month 9 (crossover participants only)
Change from Crossover Baseline in Serum Creatinine	Change in serum creatinine from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita	Month 3 to Month 9 (crossover participants only)

Collaborators and Investigators

• Sponsor: Adia Med of Winter Park LLC
• Investigators: Principal Investigator: Richard Edwards, DO, Adia Med of Winter Park LLC

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; CKD; stem cells; Glutathione; Regenerative medicine; stem cell therapy; antioxidant therapy; Glutathione therapy; allogeneic stem cells
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Renal Insufficiency, Chronic; chromium(IV)-glutathione complex
• Other Study ID Numbers: Adia Med CKD Research Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, we do not plan on sharing IPD data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No