100 Participants NeededMy employer runs this trial

AdiaVita + Glutathione for Chronic Kidney Disease

LP
Overseen ByLarry Powalisz
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Adia Med of Winter Park LLC

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for adults with chronic kidney disease (CKD) to determine if it can safely improve kidney function. The treatment, called AdiaVita, combines stem cells and exosomes from umbilical cord blood with glutathione. Researchers will compare participants across three groups: one receiving the full treatment, another receiving glutathione plus a placebo, and a third receiving placebos for both. Individuals with CKD who are not on dialysis and can attend regular clinic visits may be suitable for this trial. Researchers will closely monitor safety throughout the study to ensure the treatment's safety for participants. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, if your medication regimen is unstable or you frequently change or miss doses, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like AdiaVita, which use stem cells, are generally safe for people with kidney disease. In earlier studies, recipients reported few serious side effects, with common minor issues including mild pain at the injection site or temporary tiredness.

For glutathione, known for its antioxidant benefits, studies indicate it is usually safe when used as directed. Participants in past studies experienced only minor side effects, such as mild stomach upset or headaches.

Since this trial is in its first phase, the main focus is on safety. Researchers will closely monitor all participants, ensuring any potential side effects are quickly identified and addressed.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about AdiaVita combined with glutathione for chronic kidney disease because it represents a novel approach by utilizing stem cells. Most treatments for chronic kidney disease focus on managing symptoms and slowing progression with medications like ACE inhibitors or angiotensin receptor blockers. However, AdiaVita uses stem cells that may promote kidney repair and regeneration, offering potential for actual healing, rather than just management of the condition. This innovative mechanism could significantly change the way chronic kidney disease is treated, offering hope for more effective and comprehensive care.

What evidence suggests that AdiaVita plus glutathione might be an effective treatment for chronic kidney disease?

Research has shown that stem cell treatments, like AdiaVita, have potential in aiding individuals with chronic kidney disease (CKD). In some studies, these treatments have maintained kidney function and reduced inflammation, a common issue in CKD. Other research has found that stem cell therapy can improve kidney health in individuals with related conditions, such as diabetic kidney disease. In this trial, one group of participants will receive a combination of stem cell treatment and glutathione, a substance that combats cell damage and might further aid kidney repair. Although more research is needed, these early findings suggest that AdiaVita combined with glutathione could support kidney function in CKD patients.16789

Who Is on the Research Team?

RE

Richard Edwards, DO

Principal Investigator

Adia Med of Winter Park LLC

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 who have been diagnosed with stage 2 to 4 chronic kidney disease (CKD), are able to get regular blood tests, attend clinic visits, and are open to trying experimental treatments.

Inclusion Criteria

I am willing to try experimental treatments and follow study instructions.
I am between 18 and 80 years old.
I have chronic kidney disease with moderate to severe reduced kidney function.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly intravenous infusions and apply a skin spray twice daily at home for the first three months

3 months
3 visits (in-person) for infusions

Crossover

Certain participants in the control groups may switch to the active AdiaVita treatment if they meet safety criteria

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Regular visits for blood tests and physical exams

What Are the Treatments Tested in This Trial?

Interventions

  • AdiaVita

Trial Overview

Researchers are testing if a new treatment called AdiaVita—made from umbilical cord stem cells and exosomes plus glutathione—can safely improve kidney function in CKD. Participants will be randomly assigned to receive either the full treatment, just glutathione, or placebos.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Stem Cell + GlutathioneExperimental Treatment3 Interventions
Group II: Glutathione Control (with Crossover)Active Control3 Interventions
Group III: Placebo Control (with Crossover)Placebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adia Med of Winter Park LLC

Lead Sponsor

Citations

Adia Med of Winter Park LLC Chronic Kidney Disease ...

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Adia Nutrition wins IRB approval for CKD stem cell study

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Current advances of stem cell-based therapy for kidney ... - PMC

This review summarises the current stem cell-based therapy approaches to treat kidney diseases in experimental models and the outcomes from human clinical ...

Stem Cell Therapy for Chronic Kidney Disease

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

Efficacy of stem cell therapy for diabetic kidney disease

Abstract. Background/objectives: Animal studies have demonstrated the ability of stem cell therapy (SCT) to treat diabetic kidney disease (DKD).

Adia Nutrition Announces IRB Approval and ClinicalTrials. ...

Expected Impact: Provide robust clinical data supporting the role of stem cell therapy in kidney disease management and regeneration.

ADIA Nutrition gets IRB approval for four trials

IRB approval for four AdiaVita studies enables human trials in autism, chronic kidney disease and back pain, with a kidney study set to ...

Clinical efficacy and safety of allogeneic adipose-derived stem ...

This study highlights the significance of adipose-derived stem cells (ADSCs) as an emerging therapy for chronic kidney disease (CKD), offering ...

Adia Nutrition Announces IRB Approval and ClinicalTrials. ...

Expected Impact: Provide robust clinical data supporting the role of stem cell therapy in kidney disease management and regeneration.