Chronic Kidney DiseasePhase 1NCT07572890
Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
A Phase 1 study testing Umbilical Cord Blood-Derived Stem Cells and Exosomes, Glutathione IV and Glutathione Spray in people with Chronic Kidney Disease and Kidney Disease, run by Adia Med of Winter Park LLC at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Kidney Disease, Kidney Disease, Chronic
- What is being tested?
- Umbilical Cord Blood-Derived Stem Cells and Exosomes, Glutathione IV and Glutathione Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Adia Med Of Winter Park
Winter Park, Florida, 32789
Larry Powalisz, 3217880850, research@adiamed.com
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease, Kidney Disease, Kidney Disease, Chronic, Chronic Kidney Disease (CKD), CKD
- Being tested
- Umbilical Cord Blood-Derived Stem Cells and Exosomes, Glutathione IV, Glutathione Spray, Placebo IV, Placebo Glutathione IV
- Keywords
- allogeneic stem cells, antioxidant therapy, stem cell therapy, stem cells, Chronic Kidney Disease, CKD, Regenerative medicine, Glutathione, Glutathione therapy
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood-Derived Stem Cells and ExosomesBiological
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Glutathione IVDrug
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
Glutathione SprayDrug
Transdermal glutathione spray (4 sprays applied twice daily to the skin).
Placebo IVOther
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
Placebo Glutathione IVOther
Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.
Placebo SprayOther
Matched placebo transdermal spray (4 sprays applied twice daily).
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell + Glutathione | Experimental | Not described Receives: Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes; Drug: Glutathione IV; Drug: Glutathione Spray |
| Glutathione Control (with Crossover) | Active comparator | Not described Receives: Drug: Glutathione IV; Other: Placebo IV; Other: Placebo Spray |
| Placebo Control (with Crossover) | Placebo comparator | Not described Receives: Other: Placebo IV; Other: Placebo Glutathione IV; Other: Placebo Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in eGFR (mL/min/1.73 m²)
Measured: Baseline to Month 6
Change from Baseline in Serum Creatinine
Change from baseline in serum creatinine level (mg/dL)
Measured: Baseline to Month 6
Secondary outcomes (3)
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Number and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) in each treatment arm
Measured: From first infusion through Month 12
Change from Crossover Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita
Measured: Month 3 to Month 9 (crossover participants only)
Change from Crossover Baseline in Serum Creatinine
Change in serum creatinine from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita
Measured: Month 3 to Month 9 (crossover participants only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start18 May 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adia Med of Winter Park LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Edwards, DO, Principal investigator, Adia Med of Winter Park LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572890
- Sponsor's protocol ID
- Adia Med CKD Research Study
- Status last verified
- Jun 2026
- First submitted
- 1 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No, we do not plan on sharing IPD data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adia Med of Winter Park LLC Chronic Kidney Disease Research Study
- ClinicalTrials.gov ID
- NCT07572890
- Acronym / sponsor ID
- Adia Med CKD Research Study
- Conditions
- Chronic Kidney Disease, Kidney Disease, Kidney Disease, Chronic, Chronic Kidney Disease (CKD), CKD
- Keywords
- allogeneic stem cells, antioxidant therapy, stem cell therapy, stem cells, Chronic Kidney Disease, CKD, Regenerative medicine, Glutathione
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Adia Med of Winter Park LLCUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stem Cell + Glutathione | Experimental | Biological: Umbilical Cord Blood-Derived Stem Cells and Exosomes, Drug: Glutathione IV, Drug: Glutathione Spray |
| Glutathione Control (with Crossover) | Active comparator | Drug: Glutathione IV, Other: Placebo IV, Other: Placebo Spray |
| Placebo Control (with Crossover) | Placebo comparator | Other: Placebo IV, Other: Placebo Glutathione IV, Other: Placebo Spray |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Has
- Severe allergies to study products
- Significant uncontrolled medical conditions
- Immunocompromised
- Malignancy history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Blood-Derived Stem Cells and ExosomesIntravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes. | Biological | Stem Cell + Glutathione |
| Glutathione IVReduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule) | Drug | Glutathione Control (with Crossover), Stem Cell + Glutathione |
| Glutathione SprayTransdermal glutathione spray (4 sprays applied twice daily to the skin). | Drug | Stem Cell + Glutathione |
| Placebo IVMatched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product). | Other | Glutathione Control (with Crossover), Placebo Control (with Crossover) |
| Placebo Glutathione IVMatched placebo intravenous infusion administered on the same schedule as active glutathione IV. | Other | Placebo Control (with Crossover) |
| Placebo SprayMatched placebo transdermal spray (4 sprays applied twice daily). | Other | Glutathione Control (with Crossover), Placebo Control (with Crossover) |
Primary outcome
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline to Month 6
Change from baseline in eGFR (mL/min/1.73 m²)
Change from Baseline in Serum Creatinine
Time frame: Baseline to Month 6
Change from baseline in serum creatinine level (mg/dL)
3 secondary outcomes
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: From first infusion through Month 12
Change from Crossover Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Month 3 to Month 9 (crossover participants only)
Change from Crossover Baseline in Serum Creatinine
Time frame: Month 3 to Month 9 (crossover participants only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. No, we do not plan on sharing IPD data with other researchers.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Edwards, DO principal investigator
Adia Med of Winter Park LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Umbilical Cord Blood-Derived Stem Cells and Exosomes, Glutathione IV and Glutathione Spray in people with Chronic Kidney Disease and Kidney Disease, run by Adia Med of Winter Park LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larry Powalisz (3217880850, research@adiamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) (time frame: Baseline to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.