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

18. maj 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

86

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

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

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

Sponsor

Vericel Corporation

Efterforskere

  • Ledende efterforsker: Anthony J Comerota, MD, Jobst Vascular Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. april 2007

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

30. april 2007

Først indsendt, der opfyldte QC-kriterier

30. april 2007

Først opslået (Skøn)

1. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABI-55-0610-1

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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