Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Umbilical Cord Blood-Derived Stem Cells and Exosomes
  Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
• Препарат Glutathione IV
  Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
• Препарат Glutathione Spray
  Transdermal glutathione spray (4 sprays applied twice daily to the skin).
• Другое Placebo IV
  Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
• Другое Placebo Glutathione IV
  Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.
• Другое Placebo Spray
  Matched placebo transdermal spray (4 sprays applied twice daily).

Первичные конечные точки

• Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: Baseline to Month 6]
• Change from Baseline in Serum Creatinine [Срок оценки: Baseline to Month 6]

Вторичные конечные точки (3)

• Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events [Срок оценки: From first infusion through Month 12]
• Change from Crossover Baseline in Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: Month 3 to Month 9 (crossover participants only)]
• Change from Crossover Baseline in Serum Creatinine [Срок оценки: Month 3 to Month 9 (crossover participants only)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Adia Med Of Winter Park — Winter Park

Идентификаторы

NCT: NCT07572890 · Adia Med CKD Research Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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