Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

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.

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