A Phase 1 investigational study evaluating regenerative cellular therapy for adults with stage 2-4 chronic kidney disease under structured medical supervision.
This Phase 1 investigational study evaluates the safety and preliminary efficacy of AdiaVita - a regenerative therapy made from umbilical cord blood-derived stem cells and exosomes - combined with glutathione, in adults diagnosed with stage 2-4 chronic kidney disease (CKD). This 12-month, randomized, single-blind, controlled crossover study aims to determine whether the treatment improves kidney function as measured by estimated glomerular filtration rate (eGFR) and serum creatinine levels.
Conducted under structured medical supervision, the study follows defined research protocols to evaluate safety, tolerability, and preliminary observations related to regenerative medicine interventions. All participants undergo comprehensive clinical evaluations before, during, and after the study period. The study is approximately 100 adults aged 18 to 80 may participate.
Initial evaluation, medical history review, and assessment of eligibility criteria including eGFR and creatinine blood tests.
Comprehensive baseline assessments, blood work, and medical evaluations to establish starting kidney function measurements.
Monthly intravenous infusions at the clinic for 3 months (AdiaVita and/or glutathione, randomized single-blind) plus twice-daily topical glutathione spray applied at home. Blood tests and physical exams conducted at each visit.
Certain participants in the control groups may switch to the active AdiaVita treatment after three months if they meet safety criteria. This crossover ensures eligible participants have access to the investigational therapy.
Regular follow-up visits for blood tests (eGFR and creatinine), physical exams, and safety monitoring through Month 12. The total study duration per participant is 12 months.
The one-time participation fee includes all investigational procedures, physician and scientific oversight, medications, and stem cell therapies associated with the clinical study. Travel to Orlando is excluded from this cost.
The participation cost may be financed through CareCredit. This flexible payment option allows families to manage the financial aspects of participation. Qualified applicants may be eligible for 0% interest financing for up to 2 years.
If you have a sponsor for the study, please contact our clinical coordination team for information regarding 501(c)(3) nonprofit organization details and sponsorship verification processes.
This is a Phase 1, randomized, single-blind, controlled crossover trial with three treatment arms. Participants are randomly assigned to one of three groups: AdiaVita stem cells plus glutathione, glutathione with a placebo for AdiaVita, or placebos for both treatments. The study is single-blind, meaning participants will not know which treatment they receive. Approximately 100 adults aged 18 to 80 with stage 2-4 chronic kidney disease will participate.
Participants will receive monthly intravenous infusions at the clinic for the first three months and apply a topical glutathione spray twice daily at home during that period. Follow-up visits occur at regular intervals through Month 12 for blood tests, physical exams, and safety monitoring.
While this is an investigational study, participants may potentially benefit from:
Complete the form below to express interest and learn more about the study.
Complete a comprehensive screening including medical history review and initial assessments.
Our team will review your information and confirm eligibility based on study criteria.
Meet with clinical staff to review the study protocol and sign informed consent documentation.
Begin baseline evaluations and proceed with the investigational treatment protocol.
Study Information
This is a Phase 1 research study testing whether AdiaVita - a regenerative treatment 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 CKD, the kidneys gradually lose their ability to filter blood. The study compares AdiaVita plus glutathione against control treatments to see if it improves kidney function as measured by eGFR and creatinine blood tests.
Adults ages 18 to 80 years old who have a confirmed diagnosis of stage 2-4 chronic kidney disease (eGFR between 15-89 mL/min/1.73 m²). The study plans to include approximately 100 participants. A doctor will check if you qualify during screening.
The study lasts 12 months for each participant. The first 3 months involve monthly IV infusions at the clinic and twice-daily topical glutathione spray at home, followed by regular follow-up visits through Month 12 for blood tests, physical exams, and safety monitoring.
It's a randomized, single-blind study, meaning participants are randomly placed into one of three groups and do not know which treatment they receive:
Group 1: Receives AdiaVita stem cell infusions + glutathione (IV monthly for 3 months + topical spray at home).
Group 2: Receives glutathione (IV monthly for 3 months) + a placebo for AdiaVita.
Group 3: Receives placebos for both treatments.
At the Adia Med clinic in Winter Park, Florida.
This is a Phase 1, FDA-regulated investigational study. Safety is closely monitored by the research team and an independent review board throughout the study. All participants undergo regular blood tests, physical exams, and adverse event monitoring. Risks may include infusion-related reactions, allergic responses, and unknown long-term effects. The study team tracks and reports any serious problems.
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