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hCT-MSC hos barn med autismspektrumstörning (IMPACT)

28 maj 2026 uppdaterad av: Joanne Kurtzberg, MD

En fas II-studie av hCT-MSC, en navelsträngshärledd mesenkymal stromalcellsprodukt, hos barn med autismspektrumstörning

Syftet med denna fas II-studie är att fastställa effektiviteten av mänskliga navelsträngsvävnadshärledda mesenkymala stromaceller (hCT-MSC) för att förbättra social kommunikationsförmåga hos barn med autismspektrumstörning (ASD).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Syftet med denna dubbelblindade fas II-studie är att fastställa effektiviteten av humana navelsträngsvävnadshärledda mesencymala stromaceller (hCT-MSC), administrerade i två olika doseringsstrategier, hos barn med autismspektrumstörning (ASD).

Denna studie kommer att registrera barn med ASD i åldrarna 4-11 år. Kvalificerade försökspersoner kommer att genomgå neuropsykologisk utvärdering, EEG-tester, ögonspårning, CVA-bedömningar och infusion av studieprodukt. Försökspersoner kommer att randomiseras till en av två studiegrupper; 1) en enda infusion av 6,0x106 celler/kg vid baslinjen, följt av en blindad placeboinfusion vid sex månader eller, 2) Placeboinfusion vid baslinjen, följt av en intravenös dos på 6x106 celler/kg vid sex månader.

Det primära effektmåttet för denna studie är förändringen i social kommunikationsförmåga från baslinjen till sex månader. De potentiella riskerna förknippade med infusion av MSC inkluderar en reaktion på produkten (utslag, andnöd, väsande andning, andningssvårigheter, hypotoni, svullnad runt munnen, halsen eller ögonen, takykardi, diafores), överföring av infektion och HLA-sensibilisering.

Studietyp

Interventionell

Inskrivning (Faktisk)

137

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27705
        • Duke University Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 11 år (Barn)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier

  1. Ålder ≥ 4 år till < 12 år (11 år, 364 dagar) vid tidpunkten för samtycke
  2. Bekräftad klinisk DSM-5-diagnos av autismspektrumstörning med hjälp av DSM-5-checklistan enligt informationen från Brief Observation of Symptoms of Autism (BOSA) och Autism Diagnostic Interview-Revised (ADI-R)
  3. Fragil X-testning utförd och negativ; CMA och/eller hel exome-sekvensering utförd och resultat inte kopplade till autismdiagnos
  4. Stabil på nuvarande psykiatrisk medicinering (dos och doseringsschema) i minst 2 månader före infusion av studieprodukten
  5. Normalt absolut lymfocytantal (≥1200/uL för deltagare i afroamerikanska amerikaner och ≥1500/uL för alla andra deltagare)
  6. GAI ≥ 65 via kognitiva tester av studiepersonal
  7. Deltagare och förälder/vårdnadshavare är engelsktalande
  8. Kan resa till Duke University två gånger (baslinje, sex månader), och förälder/vårdnadshavare kan delta i interimsundersökningar och intervjuer
  9. Förälders/vårdnadshavares samtycke från minst en förälder/vårdnadshavare

Exklusions kriterier

  1. Allmän:

    1. Granskning av journaler och/eller screeningbedömningar indikerar ASD-diagnos och/eller GAI > 65 inte säker
    2. Känd diagnos av något av följande psykiatriska tillstånd samtidigt: depression, bipolär sjukdom, schizofreni, tvångssyndrom associerad med bipolär sjukdom, Tourettes syndrom
    3. Screeningsdata tyder på att deltagare inte skulle kunna uppfylla kraven i studieprocedurerna som bedömts av studiegruppen
    4. Familjen är ovillig eller oförmögen att förbinda sig att delta i alla studierelaterade bedömningar, inklusive protokolluppföljning
    5. Syskon är inskriven i denna (Duke IMPACT) studie

  2. Genetisk:

    1. Journaler visar att barnet har ett känt genetiskt syndrom såsom (men inte begränsat till) Fragilt X-syndrom, neurofibromatos, Retts syndrom, tuberös skleros, PTEN-mutation, cystisk fibros, muskeldystrofi eller en genetisk defekt som definitivt är känd för att vara associerad med ASD
    2. Känd patogen mutation eller kopietalsvariation (CNV) associerad med ASD (t.ex. 16p11.2, 15q13.2, 2q13.3)

  3. Infektiös:

    1. Känd aktiv CNS-infektion
    2. Bevis på okontrollerad infektion baserat på register eller klinisk bedömning
    3. Känd HIV-positivitet
    4. Exponering för covid-19 under de föregående 14 dagarna eller positivt covid-19-test under de föregående 28 dagarna. Försökspersoner med en tidigare historia av infektion med covid-19 måste vara symptomfria i 14 dagar före det första besöket.

  4. Medicinsk:

    1. Känd metabol störning
    2. Känd mitokondriell dysfunktion
    3. Historik med instabil epilepsi eller okontrollerad anfallsstörning, infantila spasmer, Lennox Gastauts syndrom, Dravets syndrom eller annan liknande kronisk anfallsstörning
    4. Aktiv malignitet eller tidigare malignitet som behandlats med kemoterapi
    5. Historik av en primär immunbriststörning
    6. Historik av autoimmuna cytopenier (dvs ITP, AIHA)
    7. Samexisterande medicinskt tillstånd som skulle ge barnet ökad risk för komplikationer av studieprocedurer
    8. Samtidig genetisk eller förvärvad sjukdom eller samsjuklighet(er) som kan kräva en framtida stamcellstransplantation
    9. Betydande sensorisk (t.ex. blindhet, dövhet, okorrigerad hörselnedsättning) eller motorisk (t.ex. cerebral pares) funktionsnedsättning
    10. Nedsatt njur- eller leverfunktion som bestäms av serumkreatinin >1,5 mg/dL eller totalt bilirubin >1,3 mg/dL, förutom hos patienter med känd Gilberts sjukdom
    11. Signifikanta hematologiska avvikelser definierade som: Hemoglobin <10,0 g/dL, Trombocyter <150 x 10e9/uL, WBC <3 000 celler/mL, ALC <1200/uL för afroamerikaner eller <1500/uL för alla andra deltagare.
    12. Bevis på kliniskt relevant fysisk dysmorfologi som tyder på ett genetiskt syndrom som bedömts av PI:erna eller andra utredare, inklusive en medicinsk genetiker och psykiatriker utbildade i att identifiera dysmorfa egenskaper associerade med neuroutvecklingstillstånd.

  5. Nuvarande/tidigare terapi:

    a. Tillgänglighet av en bankad, kvalificerad autolog navelsträngsblodenhet eller föräldrar uppskjuten användning av kvalificerad, autolog navelsträngsblodenhet b. Historik om tidigare cellterapi c. Aktuell eller tidigare användning av IVIG eller andra antiinflammatoriska läkemedel med undantag för NSAID d. Pågående eller tidigare immunsuppressiv terapi i. Ingen systemisk steroidbehandling som har varat >2 veckor och inga systemiska steroider inom 3 månader före inskrivningen. Aktuella och inhalerade steroider är tillåtna.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MSC
En dos av 6x10e6 celler/kg administrerad intravenöst.
Biologisk: Mesenkymala stromaceller från sladdvävnad
Humana navelsträngsvävnadshärledda mesenkymala stromaceller (hCT-MSC), isolerade och expanderade från navelsträngsvävnad från allogena icke-relaterade donatorer. En dos av 6x10e6 celler/kg administrerad intravenöst.
Placebo-jämförare: Placebo infusion
Övrig: Placebo infusion
Placebo jämförande infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change on the Average Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales (VABS-3)
Tidsram: Baseline, 6 months
The primary outcome measure is the mean of the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form. The primary endpoint is the change in this outcome measure from baseline to six months before the second infusion. A positive change in the scores indicates an improvement in socialization and communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in VABS-3 (Vineland Adaptive Behavior Scales) Socialization Standard Score
Tidsram: Baseline, 6 months
The change in the Socialization Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from baseline to six months. Higher Socialization Standard scores indicate greater socialization. A positive change in the scores indicates an improvement in socialization. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 Communication Standard Score
Tidsram: Baseline, 6 months
The change in the Communication Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form from baseline to six months before the second infusion. Higher scores indicate greater communication. A positive change in the scores indicates an improvement in communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
CGI-S (Clinical Global Impression - Severity of Illness) Overall Score
Tidsram: 6 months
The CGI-S Overall Score is a 7-point scale that requires the clinician to rate the severity of the participant's overall functioning and symptoms of autism at the time of assessment, relative to the clinician's experience with participants who have the same diagnosis. The clinician rates the severity of autism symptoms - 1, normal, no symptoms; 2, borderline level of symptoms; 3, mild symptoms; 4, moderate symptoms; 5, marked symptoms; 6, severe symptoms; or 7, extremely severe symptoms. The higher ratings indicate greater severity of overall functioning impairment.
6 months
CGI-I (Clinical Global Impression - Improvement) Overall Score
Tidsram: 6 months
The CGI-I Overall Score is a 7-point scale that requires the clinician to assess how much the participant's autism overall functioning and symptoms have improved or worsened relative to a baseline assessment. The symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The lower scores indicate greater improvement.
6 months
Change in the Pediatric Quality of Life (PedsQL) Total Scale Score
Tidsram: Baseline, 6 months
The PedsQL 4.0 Generic Core Scales is a 5-minute parent questionnaire that measures the child's functioning in the dimensions of physical, emotional, social, and school. The items use a Likert rating scale from 0 (Never) to 4 (Almost Always). This 0-4 scale is then transformed to 0=100, 1=75, 2=50, 3=25, and 4=0 for a reverse score. The Total Scale Score is then computed as the sum of all the items over the number of items answered on all the Scales for a total score range of 0 to 100. Higher scores indicate a better quality of life.
Baseline, 6 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants Experiencing an Infusion Reaction
Tidsram: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not what they were randomized. Patients received the infusion to which they were randomized at baseline and the alternate treatment at 6 months. Therefore, adverse events are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion).
up to 12 months
Number of Participants Experiencing Product-related Infections
Tidsram: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Evidence of Formation of Anti-HLA Antibodies
Tidsram: Baseline, 6 months, 12 months
Assess for anti-HLA antibodies
Baseline, 6 months, 12 months
Number of Participants Experiencing Graft Versus Host Disease (GVHD)
Tidsram: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Number of Participants Experiencing Unexpected Adverse Events Related to the Study Product
Tidsram: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Change on the Adaptive Behavior Composite Subscale Standard Score on the Vineland Behavior Scales (VABS-3)
Tidsram: Baseline, 6 months
The change in the Vineland Adaptive Behavior Scales (VABS-3) Adaptive Behavior Composite Subscale from baseline to 6 months before the second infusion. Higher Adaptive Behavior Composite Standard scores indicate greater adaptive behavior. A positive change in the scores indicates an improvement in adaptive behavior. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 (Vineland Adaptive Behavior Scales) Daily Living Skills Standard Score
Tidsram: Baseline, 6 months
The change in the Daily Living Skills Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from baseline to six months before the second infusion. Higher Daily Living Skills Standard scores indicate greater daily living skills. A positive change in the scores indicates an improvement in daily living skills. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 Motor Skills Standard Score
Tidsram: Baseline, 6 months
The change in the Motor Skills Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form from baseline to six months before the second infusion. Higher scores indicate greater motor skills. A positive change in the scores indicates an improvement in motor skills. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in Aberrant Behavior Checklist-Community (ABC-C) Social Withdrawal
Tidsram: Baseline, 6 months
The change in the Aberrant Behavior Checklist-Community (ABC-C) Social Withdrawal scale from baseline to six months before the second infusion. Higher scores indicate greater problems with social withdrawal. A positive change in the scores indicates a worsening in social withdrawal. This scale has 16 items that are scored on a 4-point Likert scale: 0 = not a problem, 1 = slight problem, 2 = moderately serious problem, 3 = severe problem. The individual items are added together to calculate the Social Withdrawal scale score.
Baseline, 6 months
Change in Pervasive Developmental Disorder Behavior Inventory (PDDBI) Total Score
Tidsram: Baseline, 6 months
The change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI) from baseline to 6 months before the second infusion. The PDDBI is a measure of problem behaviors and social, language, and learning or memory skills of children who have been diagnosed with autism spectrum disorder. Raw scores are converted to T-scores. The T-score has a mean of 50 with a standard deviation of 10 points with a range of 10-100. Higher scores indicate greater behavioral issues and a positive change in score indicates worsening.
Baseline, 6 months
Change in the Autism Impact Measure (AIM)
Tidsram: Baseline, 6 months
The change in the Autism Impact Measure (AIM) from baseline to 6 months before second infusion. AIM is a measure of core Autism Spectrum Disorder Symptoms. It is a parent-report questionnaire that includes 41 core-symptom items rated on two corresponding 5-point scales: frequency (ranging from "never" to "always") and impact (ranging from "not at all" to "severely") over the previous two weeks. Frequency and impact ratings are combined, yielding a total score range of 82 to 410. Higher scores indicate greater symptom severity; a positive change in score indicates worsening of symptoms.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Emotional Control Subscale
Tidsram: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Emotional Control subscale from baseline to month 6 before the second infusion. BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Working Memory Subscale
Tidsram: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Working Memory subscale from baseline to month 6 before the second infusion. The BREIF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Inhibit Subscale
Tidsram: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Inhibit subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Plan/Organization Subscale
Tidsram: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Plan/Organization subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Shift Subscale
Tidsram: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Shift subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Expressive Vocabulary Test (Third Edition, EVT-3)
Tidsram: Baseline, 6 months
The change in the Expressive Vocabulary Test (Third Edition, EVT-3) from baseline to 6 months before the second infusion. The EVT-3 is a measure of a participant's ability to match a spoken word with an image of an object, action, or concept. The number of words that are retrieved is converted to a Standard Score, where 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers. A positive change in EVT-3 score indicates improvement.
Baseline, 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Joanne Kurtzberg, MD

Samarbetspartners

The Marcus Foundation
Cryo-Cell International

Utredare

  • Huvudutredare: Lauren Franz, MBChB, Duke University
  • Huvudutredare: Beth Shaz, MD, Duke University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 oktober 2020

Primärt slutförande (Faktisk)

2 maj 2023

Avslutad studie (Faktisk)

1 februari 2024

Studieregistreringsdatum

Först inskickad

12 september 2019

Först inskickad som uppfyllde QC-kriterierna

12 september 2019

Första postat (Faktisk)

13 september 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00113011
  • Pro00102894 (Annan identifierare: Duke IRB)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera