Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

NCT07572890 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: Adia Med CKD Research Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Kidney Disease; Kidney Disease, Chronic; Chronic Kidney Disease (CKD); CKD

Keywords

allogeneic stem cells; antioxidant therapy; stem cell therapy; stem cells; Chronic Kidney Disease; CKD; Regenerative medicine; Glutathione; Glutathione therapy

Outcome Measures

Primary Outcomes (2)

• Change in Estimated Glomerular Filtration Rate (eGFR)

  Change from baseline in eGFR (mL/min/1.73 m²)

  Baseline to Month 6

• Change in Serum Creatinine

  Change from baseline in serum creatinine level (mg/dL)

  Baseline to Month 6

Secondary Outcomes (3)

• Incidence of Adverse Events and Serious Adverse Events

  From first infusion through Month 12

• Change in eGFR after Crossover

  Month 3 to Month 9 (crossover participants only)

• Change in Serum Creatinine after Crossover

  Month 3 to Month 9 (crossover participants only)

Study Arms (3)

Stem Cell + Glutathione

EXPERIMENTAL

Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Drug: Glutathione IV; Drug: Glutathione Spray

Glutathione Control (with Crossover)

ACTIVE COMPARATOR

Drug: Glutathione IV; Other: Placebo IV; Other: Placebo Spray

Placebo Control (with Crossover)

PLACEBO COMPARATOR

Other: Placebo IV; Other: Placebo Glutathione IV; Other: Placebo Spray

Interventions

Umbilical Cord Blood-Derived Stem Cells and Exosomes BIOLOGICAL

Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.

Stem Cell + Glutathione

Glutathione IV DRUG

Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)

Glutathione Control (with Crossover); Stem Cell + Glutathione

Glutathione Spray DRUG

Transdermal glutathione spray (4 sprays applied twice daily to the skin).

Stem Cell + Glutathione

Placebo IV OTHER

Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).

Glutathione Control (with Crossover); Placebo Control (with Crossover)

Placebo Glutathione IV OTHER

Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.

Placebo Control (with Crossover)

Placebo Spray OTHER

Matched placebo transdermal spray (4 sprays applied twice daily).

Glutathione Control (with Crossover); Placebo Control (with Crossover)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adia Med of Winter Park LLC: lead

Study Sites (1)

Adia Med Of Winter Park

Winter Park, Florida, 32789, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Interventions

chromium(IV)-glutathione complex

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evan Thomas, MD, PhD

  Adia Med of Winter Park LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Powalisz

CONTACT

3212312843; ceo@adiamed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)