Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia (ABC)

5. juli 2011 opdateret af: Leiden University Medical Center

Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia A Double Blind, Placebo Controlled, Study in Diabetic and Non-diabetic Patients

The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Although the safety and beneficial effects of intramuscular transplantation of bone marrow derived mononuclear cells procedure appear well documented, a number of critical question regarding application of BM-MNC for peripheral vascular disease remain to be answered. First, although the original study has been partially performed as semi-blinded study (patients with double sided claudication were recruited and blindly treated with BM-MNC in one leg and peripheral blood injections in the other leg), this approach does exclude a placebo effect. Second, although patients with mild diabetes were included in the protocol, the results for diabetic patients were not analyzed separately. Diabetic disease is characterized by monocyte and endothelial progenitor cell dysfunction and it is still unclear whether this approach is also effective in diabetic patients. Third, although six-month results are reported long-term efficacy has not been established yet.

To address these issues, the investigators now propose confirm and extend the findings from open studies in a randomized double-blind study in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

108

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Holland
      • Leiden, Holland, 2300RC
        • Rekruttering
        • Leiden University Medical Center
        • Kontakt:
          • Jan HN Lindeman, MD, PhD
          • Telefonnummer: #31 (0)71 5263968
          • E-mail: Lindeman@lumc.nl

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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • persistent (>3 months) disabling claudication (Fontaine's stages IIb or Rutherford's categories 3, viz. pain free walking distance less than 100 meter) despite optimal therapy or critical limb ischemia (Fontaine's stages III/IV or Rutherford's categories 4-6)
  • ineligibility for angioplasty or bypass procedures
  • male of female, >18 years old
  • life expectancy > 1 year
  • written informed consent

Exclusion Criteria:

  • candidates for angioplasty or bypass procedures
  • inability to undergo bone marrow harvesting
  • any condition in the affected limb that is anticipated to require surgical intervention in the first weeks after BM-MNC treatment
  • life threatening co-morbidity
  • poorly controlled diabetes (HbA1C > 10%)
  • active malignancy in the 5 years prior to treatment
  • INR >1.5 at the time of bone-marrow harvest
  • bleeding diathesis
  • inability to undergo arterial catheterization
  • inability to follow the protocol and to comply with the follow up requirements
  • any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
non diabetic patients with Fontaine IIb-IV peripheral artery disease
Biologisk: bone marrow derived mononuclear cells
40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
Placebo komparator: 2
non diabetic patients with Fontaine IIb-IV peripheral artery disease
Biologisk: placebo
40 IM injections (calf muscle) of placebo suspension
Aktiv komparator: 3
diabetic patients with Fontaine IIb-IV peripheral artery disease
Biologisk: bone marrow derived mononuclear cells
40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
Placebo komparator: 4
diabetic patients with Fontaine IIb-IV peripheral artery disease
Biologisk: placebo
40 IM injections (calf muscle) of placebo suspension

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Limb salvage/wound healing at t=6 months; Pain free walking distance
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
quality of life (RAND-36), pain Scores (Brief Pain Inventory), tcO2 (wrist/ankle ratio) ABI Collateral artery scores (angiogram) at t=6 months, Limb salvage/wound healing at t= 3 and 12 months, Pain free walking distance at t=3 and 12 months,
Tidsramme: 3, 6 and 12 months
3, 6 and 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Leiden University Medical Center

Efterforskere

  • Ledende efterforsker: Jan HN Lindeman, MD, PhD, Leiden University Medical 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. oktober 2007

Primær færdiggørelse (Forventet)

1. oktober 2012

Studieafslutning (Forventet)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

3. oktober 2007

Først indsendt, der opfyldte QC-kriterier

3. oktober 2007

Først opslået (Skøn)

4. oktober 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2011

Sidst verificeret

1. oktober 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P07.058

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 Perifere vaskulære sygdomme

Kliniske forsøg med bone marrow derived mononuclear cells

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Canada

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner