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Adia Med of Winter Park LLC Chronic Kidney Disease Research Study

16. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Winter Park, Florida, Forenede Stater, 32789
        • Rekruttering
        • Adia Med Of Winter Park
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Stem Cell + Glutathione
Biologisk: Stamceller og eksosomer fra navlestrengsblod
Intravenøs infusion af kryokonserveret allogent navlestrengsblod-afledt produkt indeholdende levedygtige mononukleære celler (inklusive hematopoietiske og mesenchymale stam-/stromalceller) og exosomer.
Medicin: Glutathione IV
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
Medicin: Glutathione Spray
Transdermal glutathione spray (4 sprays applied twice daily to the skin).
Aktiv komparator: Glutathione Control (with Crossover)
Medicin: Glutathione IV
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)
Andet: Placebo IV
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
Andet: Placebo Spray
Matched placebo transdermal spray (4 sprays applied twice daily).
Placebo komparator: Placebo Control (with Crossover)
Andet: Placebo IV
Matched placebo intravenous infusion (administered in the same volume and manner as stem cell and exosome product).
Andet: Placebo Spray
Matched placebo transdermal spray (4 sprays applied twice daily).
Andet: Placebo Glutathione IV
Matched placebo intravenous infusion administered on the same schedule as active glutathione IV.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Tidsramme: Baseline to Month 6
Change from baseline in eGFR (mL/min/1.73 m²)
Baseline to Month 6
Change from Baseline in Serum Creatinine
Tidsramme: Baseline to Month 6
Change from baseline in serum creatinine level (mg/dL)
Baseline to Month 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Adia Med of Winter Park LLC

Efterforskere

  • Ledende efterforsker: Richard Edwards, DO, Adia Med of Winter Park LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

18. maj 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Adia Med CKD Research Study

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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