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Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia (MESENDO)

7. maj 2014 opdateret af: TCA Cellular Therapy

Phase II Safety/Efficacy Study of A Combination Stem Cell Therapy That Develops Mature Stable Vessel Formation in Ischemic Limbs

The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.

Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.

LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.

In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.

The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.

Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.

Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

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
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • TCA Cellular Therapy

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

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Males or females older than 18 years of age.
  • Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart.
  • Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers.
  • Claudication
  • Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia.

Exclusion Criteria:

  • Inability to provide informed consent.
  • Previous angiogenic therapy.
  • Known sensitivity to gentamycin and/or amphotericin B.
  • Use or expected use of antineoplastic drugs.
  • Any illness, which might affect the patient's survival after enrollment in the protocol.
  • Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results.
  • No evidence of acute infection
  • WBC > 15000.
  • WBC < 4000.
  • Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis.
  • Pregnant women or women planning to become pregnant or unwilling to use appropriate birth control methods before and 2 months after cell infusion.
  • Recent myocardial infarction within 3 months prior to screening.

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MESENDO
All subjects will receive active treatment in a blinded fashion in the left or right lower limb. The opposite lower limb will receive placebo.
Biologisk: MESENDO
40 subcutaneous injections of biological product
Placebo komparator: placebo
All subjects will receive placebo injections in a blinded fashion in the left or right lower limb. The opposite lower limb will receive active stem cell infusion
Biologisk: Placebo
40 subcutaneous injections of placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia.
Tidsramme: 4 months
4 months

Sekundære resultatmål

Resultatmål
Tidsramme
Changes in resting leg pain identified by a Visual Analog Scale and patient safety
Tidsramme: 4 months
4 months

Samarbejdspartnere og efterforskere

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

Sponsor

TCA Cellular Therapy

Efterforskere

  • Ledende efterforsker: Gabriel P Lasala, M.D., TCA Cellular Therapy, LLC

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. juni 2008

Primær færdiggørelse (Faktiske)

1. august 2010

Studieafslutning (Faktiske)

1. september 2010

Datoer for studieregistrering

Først indsendt

21. juli 2008

Først indsendt, der opfyldte QC-kriterier

22. juli 2008

Først opslået (Skøn)

23. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2014

Sidst verificeret

1. september 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2008-01-II

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 Perifer vaskulær sygdom

Kliniske forsøg med MESENDO

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Switzerland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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