Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

Part of paid clinical trials in Winter Park, Florida.

Sponsor: Adia Med of Winter Park LLC
Study ID: NCT07572890
Phase: PHASE1
Status: Recruiting

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Conditions

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

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

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.
Glutathione IV — DRUG
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
Glutathione Spray — DRUG
Transdermal glutathione spray (4 sprays applied twice daily to the skin).
Placebo IV — OTHER
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
Placebo Glutathione IV — OTHER
Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.
Placebo Spray — OTHER
Matched placebo transdermal spray (4 sprays applied twice daily).

Study Details

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.