- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03239535
Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
1. august 2017 opdateret af: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem cells for the treatment of critical limb ischemia.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mikhail A Konoplyannikov, PhD
- Telefonnummer: +79154027268
- E-mail: mkonopl@mail.ru
Studiesteder
-
-
-
Moscow, Den Russiske Føderation
- Rekruttering
- Federal Research Clinical Center of Federal Medical & Biological Agency
-
Kontakt:
- Mikhail A Konoplyannikov, PhD
- Telefonnummer: +79154027268
- E-mail: mkonopl@mail.ru
-
-
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 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Males or females in the age group of 18-80 yrs of Caucasian origin.
- Peripheral artery disease (PAD) against the background of atherosclerosis and diabetes mellitus (DM)
- Critical lower limb ischemia (stages 3-4 by Fontaine-Pokrovsky or stages 4-6 by Rutherford)
- Patients with remaining symptoms of critical limb ischemia (CLI) in spite of the performed surgical (endovascular or open) treatment and continuing conservative therapy
- Patients with absent emergency indications to major amputation
- Patients planned for the reconstructive surgery with a questionable remote outcome due to compromised blood outflow
- Ankle Brachial Pressure Index (ABPI) ≤ 0.5 or ankle pressure ≤ 70 mm Hg
- Patients, if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8.5 %)
- On regular medication for hypertension if needed
- Normal liver and renal function (or having clinically insignificant deviations, according to the treating physician's opinion)
- Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits
Exclusion Criteria:
- Humid gangrene or acute/chronic infection of lower limb.
- Dry gangrene with extensive foot lesion (> 1\2).
- Acute arterial failure.
- Life-threatening conditions and predicted life expectancy of < 6 months.
- Presence of neoplasm or bone marrow disease
- Signs of active or chronic, including latent, haemorrhage
- Any acute or chronic infectious disease
- Renal failure determined as twofold or higher elevation of serum creatinine as compared to the upper normal limit
- Hepatic failure determined as the bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevated by two and more times over the upper normal limits
- Thrombocytopenia (platelet counts < 50,000 /µl), leukocytopenia (WBC < 4,000/µl), immunosuppressive therapy
- Pronounced neurological deficit
- Patients with gait disturbance for reasons other than CLI
- Patients not suitable for cell therapy, by the treating physician's opinion
- CLI patients requiring amputation at the proximal to the trans-metatarsal level
- Patients with Type I diabetes
- Patients having respiratory complications/left ventricular ejection fraction < 25%
- Stroke or myocardial infarction within last 3 months
- Patients who are contraindicated for X-ray angiography
- History of severe alcohol or drug abuse within 3 months of screening
- Pregnant and lactating women.
- Patients tested positive for HIV 1, hepatitis C virus (HCV), hepatitis B virus (HBV)
- Unsigned informed consent
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: Mesenchymal stem cells
Mesenchymal stem cells, Intramuscular injection
|
Intramuscular injection
|
Placebo komparator: Normal saline
Normal saline, Intramuscular injection
|
Intramuscular injection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Adverse events
Tidsramme: 24 months
|
Number of adverse events reported
|
24 months
|
Amputation-free survival
Tidsramme: 24 months
|
Number of survived patients
|
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Limb salvage from major amputation
Tidsramme: 3, 6, 12, 24 months
|
Number of patients who avoided amputation
|
3, 6, 12, 24 months
|
Relief of the rest pain
Tidsramme: Immediate, 3, 6, 12, 24 months
|
Rest pain will be measured using the rest pain scale
|
Immediate, 3, 6, 12, 24 months
|
Improvement in healing trophic disorders
Tidsramme: Immediate, 3, 6, 12, 24 months
|
Assessment of the severity of trophic ulcers
|
Immediate, 3, 6, 12, 24 months
|
Improvement in perfusion by the ankle-brachial index
Tidsramme: Immediate, 3, 6, 12, 24 months
|
Measurements of the ankle-brachial index
|
Immediate, 3, 6, 12, 24 months
|
Improvement in perfusion by radioisotope scintigraphy
Tidsramme: Immediate, 3, 6, 12, 24 months
|
Radioisotope scintigraphy study
|
Immediate, 3, 6, 12, 24 months
|
Improvement in total walking distance (TWD) using a standard treadmill test
Tidsramme: Immediate, 3, 6, 12, 24 months
|
Standard treadmill test
|
Immediate, 3, 6, 12, 24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Vladimir P Baklaushev, MD, PhD, Deputy Director
- Ledende efterforsker: Pavel Yu Orekhov, MD, PhD, Vascular surgeon
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 (Faktiske)
1. oktober 2013
Primær færdiggørelse (Forventet)
1. august 2018
Studieafslutning (Forventet)
1. november 2018
Datoer for studieregistrering
Først indsendt
20. juli 2017
Først indsendt, der opfyldte QC-kriterier
1. august 2017
Først opslået (Faktiske)
4. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MSC-CLI/FMBA/001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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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