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Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

2026年6月16日 更新者：Adia Med of Winter Park LLC
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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

100

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Florida
      • Winter Park、Florida、アメリカ、32789
        • 募集
        • Adia Med Of Winter Park
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Stem Cell + Glutathione
生物学的：臍帯血由来幹細胞とエクソソーム
生存可能な単核細胞（造血幹細胞および間葉系幹細胞／間質細胞を含む）とエクソソームを含む、凍結保存された同種臍帯血由来製剤の静脈内投与
薬：Glutathione IV
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
薬：Glutathione Spray
Transdermal glutathione spray (4 sprays applied twice daily to the skin).
アクティブコンパレータ：Glutathione Control (with Crossover)
薬：Glutathione IV
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
他の：Placebo IV
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
他の：Placebo Spray
Matched placebo transdermal spray (4 sprays applied twice daily).
プラセボコンパレーター：Placebo Control (with Crossover)
他の：Placebo IV
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
他の：Placebo Spray
Matched placebo transdermal spray (4 sprays applied twice daily).
他の：Placebo Glutathione IV
Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
時間枠：Baseline to Month 6
Change from baseline in eGFR (mL/min/1.73 m²)
Baseline to Month 6
Change from Baseline in Serum Creatinine
時間枠：Baseline to Month 6
Change from baseline in serum creatinine level (mg/dL)
Baseline to Month 6

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
時間枠：From first infusion through Month 12
Number and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) in each treatment arm
From first infusion through Month 12
Change from Crossover Baseline in Estimated Glomerular Filtration Rate (eGFR)
時間枠：Month 3 to Month 9 (crossover participants only)
Change in eGFR from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita
Month 3 to Month 9 (crossover participants only)
Change from Crossover Baseline in Serum Creatinine
時間枠：Month 3 to Month 9 (crossover participants only)
Change in serum creatinine from the start of crossover (Month 3) to Month 9 in participants from Arms 2 and 3 who receive AdiaVita
Month 3 to Month 9 (crossover participants only)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Adia Med of Winter Park LLC

捜査官

  • 主任研究者：Richard Edwards, DO、Adia Med of Winter Park LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月18日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2029年1月1日

試験登録日

最初に提出

2026年5月1日

QC基準を満たした最初の提出物

2026年5月1日

最初の投稿 (実際)

2026年5月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月17日

QC基準を満たした最後の更新が送信されました

2026年6月16日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Adia Med CKD Research Study

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

No, we do not plan on sharing IPD data with other researchers.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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