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Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

17. september 2021 opdateret af: Castle Creek Biosciences, LLC.

A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars. The study will assess the effects of azficel-T (autologous fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:

  1. An axillary scar causing 20-60% restriction of shoulder adduction
  2. An anterior elbow scar causing 20-60% restriction of elbow extension
  3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension

Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7 days) apart (depending on cell availability) and will be followed for efficacy (including range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for safety to Visit 9 at 1 year.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95817
        • Univ of California David Medical Center
      • San Diego, California, Forenede Stater, 92103
        • Univ of California San Diego
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Division of Burns and Trauma, Jackson Memorial Hospital
    • Illinois
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Richard M. Fairbanks Burn Center
    • New York
      • Garden City, New York, Forenede Stater, 11530
        • Long Island Plastic Surgical Group
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Health Network
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Center for Innovation in Restorative Medicine
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Univ of Washington, Harborview Medical Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subject is at least 18 years of age

  2. Subject has a unilateral burn scar of a jointed area (i.e., finger, elbow, shoulder) that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:

    1. An axillary scar causing 20-60% restriction of shoulder abduction
    2. An anterior elbow scar causing 20-60% restriction of elbow extension
    3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
  3. Subject's burn scar to be treated is <100 sq cm in size
  4. Injury occurred ≤ 36 months prior to screening
  5. By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
  6. Subject agrees to maintain any current physical therapy regimen for the duration of the study
  7. Subject must be able to provide written informed consent and comply with the study requirements
  8. Females of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to the first treatment, and must agree to use a reliable means of birth control for the duration of the study
  9. Subject has healthy, non-scarred post auricular skin area suitable for biopsy
  10. Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment

Exclusion Criteria:

  1. Restrictive burn scars that are primarily classified as keloid scars
  2. Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
  3. Sunburn or sun damage in the area that will be used for biopsy
  4. Plans to initiate any other new scar therapy during the study period
  5. Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study
  6. History of active autoimmune disease or organ transplantation
  7. Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
  8. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, Ehlers Danlos syndrome, etc.
  9. Active systemic infection
  10. Requires chronic antibiotic or steroidal therapy
  11. Any conditions that are considered by the Investigator to be contraindications to biopsy or injection
  12. Pregnant or lactating women, or women trying to become pregnant during the study
  13. Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the Investigator's opinion, interfere with the study
  14. Presence of other disease or condition that would result in impairment of the range of motion of the extremity, e.g., rheumatoid arthritis or stroke

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: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Autologous fibroblasts
Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
Biologisk: Autologous fibroblasts
Andre navne:
  • Azficel-T
Placebo komparator: Sterile saline
Sterile saline will be injected into the scar to be evaluated.
Biologisk: Autologous fibroblasts
Andre navne:
  • Azficel-T
Biologisk: placebo sterile saline

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
Tidsramme: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Percentage CFB of ROM of the Affected Joint
Tidsramme: Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
Percentage CFB of ROM of the Affected Joint
Tidsramme: Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
Percentage CFB of ROM of the Affected Joint
Tidsramme: Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
Percentage CFB of ROM of the Affected Joint
Tidsramme: Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)

Samarbejdspartnere og efterforskere

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

Sponsor

Castle Creek Biosciences, LLC.

Efterforskere

  • Ledende efterforsker: Daniel D Lozano, MD, Lehigh Valley Health Network

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

1. maj 2013

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først indsendt

10. maj 2013

Først indsendt, der opfyldte QC-kriterier

20. maj 2013

Først opslået (Skøn)

21. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FI-B-003

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 .

Kliniske forsøg med Restrictive Burn Scars

Kliniske forsøg med Autologous fibroblasts

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guatemala

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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