Actively Recruiting
Adia Med of Winter Park LLC Chronic Kidney Disease Research Study Evaluating AdiaVita Stem Cell Therapy with Glutathione in Adults with Stage 2-4 Chronic Kidney Disease
Led by Adia Med of Winter Park LLC · Updated on 2026-06-08
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new regenerative treatment called AdiaVita, made from umbilical cord blood-derived stem cells and exosomes combined with glutathione, to see if it is safe and can improve kidney function in adults with chronic kidney disease (CKD). The trial focuses on adults aged 18 to 80 who have stage 2 to 4 CKD. The main goal is to find out if this treatment improves kidney function better than control treatments, based on blood tests measuring estimated glomerular filtration rate (eGFR) and creatinine levels, while also assessing safety and side effects. Participants are randomly assigned to one of three groups: one receives AdiaVita plus glutathione, another receives glutathione plus a placebo for AdiaVita, and the third group receives placebos for both treatments. Treatments involve monthly intravenous infusions at the clinic for three months, along with applying a skin spray twice daily at home during this period. After three months, some control group participants may switch to the active AdiaVita treatment if safety criteria are met. The study lasts 12 months for each participant. During the study, participants will have regular visits for blood tests, physical exams, and safety monitoring. Researchers will track kidney function changes and the occurrence of any adverse events. An independent board oversees safety throughout the trial. The study includes detailed monitoring, data collection, and follow-up to evaluate the effects and safety of this stem cell-based therapy for CKD.
CONDITIONS
Brief Title
Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Confirmed diagnosis of chronic kidney disease with estimated glomerular filtration rate (eGFR) between 15 and 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 study visits
You will not qualify if you...
- Severe allergies to study products
- Significant uncontrolled medical conditions
- Immunocompromised status
- History of malignancy
- Unstable medication regimen or inconsistent medication adherence within 30 days before baseline
- Current or planned dialysis during the study period
- Pregnancy or breastfeeding
- Participation in another interventional trial within 30 days
- History of kidney transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive monthly intravenous infusions of stem cell therapy combined with glutathione or placebo, along with at-home use of a topical glutathione spray during the treatment phase.
3 monthly infusion visits and daily at-home spray application
Duration - Up to 6 months
Certain participants have the option to crossover and receive the investigational therapy after the initial treatment phase if safety criteria are met.
Additional monthly infusion visits as applicable
Duration - Up to 12 months total study duration including treatment
Participants are monitored for safety, kidney function, and adverse events after treatment ends.
Periodic follow-up visits for assessments and monitoring
Trial Site Locations
Total: 1 location
1
Adia Med Of Winter Park
Winter Park, Florida, United States, 32789
Actively Recruiting
Research Team
L
Larry Powalisz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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