Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Adia Med of Winter Park LLC · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 80 who have chronic kidney disease. Participants will receive monthly treatments at the clinic and use a skin spray at home for a year to see if the new treatment helps their kidney function.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with chronic kidney disease.
I can attend all scheduled clinic visits.
I am willing to consider experimental treatments.
I can get the necessary blood tests done.
I can pay the study fee of $15,000.
You may not be able to join if
I have severe allergies to study products.
I have uncontrolled medical conditions.
I am immunocompromised.
I have a history of cancer.
I require dialysis now or plan to start during the study.
I am pregnant or breastfeeding.
I have participated in another trial in the last 30 days.
I have had a kidney transplant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
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Eligibility Criteria
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 ($1…
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
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