Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia (RESTORE-CLI)

18. mai 2020 oppdatert av: Vericel Corporation

Use of Ixmyelocel-T (Formerly TRC Autologous Bone Marrow Cells) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia.

The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to restore peripheral blood flow affected by critical limb ischemia.

Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs when peripheral arteries are damaged by arterial hypertension and/or by the formation of atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven PAD. These sequelae represent the end stage of PAD. PAD is associated with several other clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes, tobacco use, obesity and stroke.

The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular injections of the TRC product into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.

Studietype

Intervensjonell

Registrering (Faktiske)

86

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35211
        • Cardiology, P.C.
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006
        • Arizona Heart Institute
    • California
      • San Francisco, California, Forente stater, 94143
        • University of California, San Francisco
    • Florida
      • Gainesville, Florida, Forente stater, 32608
        • Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System
      • Miami, Florida, Forente stater, 33136
        • University of Miami/Miller School of Medicine
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Stritch School of Medicine
      • Springfield, Illinois, Forente stater, 62702
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46260
        • The Care Group, Llc
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48106
        • St. Joseph Mercy Hospital
      • Ann Arbor, Michigan, Forente stater, 48105
        • VA Ann Arbor Healthcare System
      • Flint, Michigan, Forente stater, 48507
        • Michigan Vascular Research Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407
        • Minneapolis Heart Institute Foundation
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth-Hitchcock Memorial Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27514
        • University of North Carolina Hospitals
    • Ohio
      • Toledo, Ohio, Forente stater, 43606
        • Jobst Vascular Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Oklahoma University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232-2735
        • Vanderbilt University Medical Center
    • Texas
      • San Antonio, Texas, Forente stater, 78205
        • Peripheral Vascular Associates
      • Temple, Texas, Forente stater, 76508
        • Scott and White Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Males and females, 18-90 years of age
  • Diagnosis of CLI
  • Infrainguinal occlusive disease, without options for revascularization
  • No surgical interventions planned
  • Life expectancy of 2 years
  • Normal organ and marrow function
  • Patients with controlled blood pressure (≤ 180/110 mmHg) and established anti-hypertensive therapy
  • Established anti-platelet therapy

Exclusion Criteria:

  • Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 10%)
  • Aortoiliac disease with > 50% stenosis
  • Wounds with severity greater than Grade 3 on the Wagner Scale
  • Any known failed ipsilateral revascularization within 2 weeks of enrollment
  • Previous amputation of the talus, or above in the target limb
  • Life-threatening ventricular arrhythmia; unstable angina; or, myocardial infarction within 4 weeks of enrollment
  • Severe congestive heart failure (CHF) (i.e. New York Heart Association [NYHA] Stage IV)
  • Receiving treatment with hematopoietic growth factors
  • Infection of the involved extremity(ies)
  • Active wet gangrenous tissue
  • Require uninterruptible anticoagulation therapy
  • Blood clotting disorder
  • Cancer
  • End stage renal disease requiring dialysis for more than 6 months prior to enrollment
  • Pregnant or lactating
  • Having received medication for thrombolytic therapy (e.g. rTPA or other enzymatic clot busters) within 30 days prior to enrollment
  • Undergoing hyperbaric oxygen treatment within 2 weeks of enrollment
  • Concomitant wound treatments with growth factors or tissue engineered products
  • Receiving anti-angiogenic drugs

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Ixmyelocel-T
The treatment arm of the study will receive injections of the study cellular product.
Biologisk: Ixmyelocel-T
IM injection
Placebo komparator: Placebo
The control arm of the study will receive placebo injections.
Biologisk: Placebo
IM Injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Safety of TRCs in patients with CLI(key safety parameters include vital signs, physical exams, laboratory results, assessment of aspiration and injection sites, adverse events, major amputations, wounds presence(size and grading using the Wagner scale)
Tidsramme: throughout trial
throughout trial

Sekundære resultatmål

Resultatmål
Tidsramme
Composite efficacy endpoint assessing time to treatment failure(failure defined as major amputation, doubling of wound size, and new gangrene)
Tidsramme: Day 7 and Months 3, 6, 9, 12
Day 7 and Months 3, 6, 9, 12
Percentage of patients failing treatment
Tidsramme: Day 7, and Months 3,6,9, and 12
Day 7, and Months 3,6,9, and 12
Time to major amputation
Tidsramme: Day 7 and Month 3, 6, 9, and 12
Day 7 and Month 3, 6, 9, and 12
Percentage of patients undergoing major amputation
Tidsramme: Day 7 and Months 3, 6, 9, 12
Day 7 and Months 3, 6, 9, 12
Incidence of revascularization interventions throughout duration of study
Tidsramme: Day 7 and Months 3,6,9,12
Day 7 and Months 3,6,9,12
Incidence of bypass surgery for patients throughout duration of study
Tidsramme: Day 7 and Months 3,6,9,12
Day 7 and Months 3,6,9,12
Healing of all wounds in the target limb
Tidsramme: Day 7 and Months 3,6,9,12
Day 7 and Months 3,6,9,12
Ankle and/or toe pressure and ankle brachial pressure index and/or toe brachial index
Tidsramme: Day 7 and Months 3,6,9,12
Day 7 and Months 3,6,9,12
Pain, as measured by visual analog scale(VAS)
Tidsramme: Day 7 and Months 3,6,9,12
Day 7 and Months 3,6,9,12
The King's College Vascular Quality of Life Questionnaire
Tidsramme: Baseline and Months 6 and 12
Baseline and Months 6 and 12
Walking distance as measured by six-minute walk test(with or without walking device)
Tidsramme: Baseline and Month 12
Baseline and Month 12
Concurrent Meds for trends
Tidsramme: Day 7 and Months 3, 6, 9, 12
Day 7 and Months 3, 6, 9, 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vericel Corporation

Etterforskere

  • Hovedetterforsker: Anthony J Comerota, MD, Jobst Vascular Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2007

Primær fullføring (Faktiske)

1. mars 2011

Studiet fullført (Faktiske)

1. mars 2011

Datoer for studieregistrering

Først innsendt

30. april 2007

Først innsendt som oppfylte QC-kriteriene

30. april 2007

Først lagt ut (Anslag)

1. mai 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ABI-55-0610-1

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Perifer arteriell sykdom

Kliniske studier på Ixmyelocel-T

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Taiwan

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere