Intraarterial Stem Cells in Subacute Ischemic Stroke
14. marts 2017 opdateret af: Vikas Bhatia, Postgraduate Institute of Medical Education and Research
To Evaluate the Safety, Feasibility and Clinical Outcome of Intraarterial Infusion of Bone Marrow Derived Mononuclear Cells in Subacute Ischaemic Stroke Patients
Stroke is a leading cause of morbidity and mortality.Acute ischemia causes irreversible damage to neurons and glial cells, leading to functional deficits and chronic sequelae with variable degrees of spontaneous recovery of function. Stem cells have been shown to enhance recovery through multiple immunomodulatory effects, neoangiogenesis and neurogenesis.
We conducted a prospective randomised end observer blinded study to evaluate primarily the safety of intraarterial autologous stem cells delivered to ipsilateral middle cerebral artery in acute and subacute stroke patients (0-15 days post ictus).Secondarily we aimed to evaluate the outcome on the basis of clinical evaluation and follow up imaging
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- This study was done over a period of one and a half years from July 2015 to December 2016. A total of 229 patients who presented with acute middle cerebral artery stroke and admitted at Post graduate institute of medical education and research were evaluated for recruitment into this study.
- Participants who satisfied the inclusion criteria were randomized at 1 week into control and stem cell infusion test group within 15 days of stroke onset.
- Investigators evaluated 20 patients, with 10 each in control and stem cell infusion test group.
- Participants in the test group were infused autologous bone marrow mononuclear cells through intraarterial route using a microcatheter which was placed in proximal ipsilateral M1 segment of MCA. Participants in the control group did not receive stem cell therapy. Rest of the pharmacological treatment and physiotherapy were similar in both groups for the period of 6 months.
5,Participants were evaluated with clinical and radiological follow up at 6 months.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Fase 1
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: Requires presence of all of the following
- Age range 20-80 years symptoms
- Signs of clinically definite MCA stroke (0 to 14 days post ictus)
- National Institute of Health Stroke Scale (NIHSS)> 7,
- Stroke clinically and on imaging conforming to the MCA territory,
- Recanalization/patency of involved M1 segment of MCA on imaging
- Patency of carotid arteries for intra-arterial access of cerebral circulation
Exclusion Criteria: Requires presence of any of the following
- cerebral hemorrhage on CT/MRI
- Imaging evidence of M1-MCA segment complete occlusion
- Hemodynamic instability
- Known defect of clotting or platelet function
- Severe co-morbidity precluding intra-arterial intervention
- Hepatic or renal dysfunction
- Pregnant patients
- Patient likely to be unavailable for follow-up
- Patients with evidence of chronic illness or advanced cancer
- Patient already dependent in activities of daily living before the present acute stroke i.e. pre stroke mRS >3
- Refusal to give 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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Stem cell group
autologous BMMNC stem cells with standard care
|
Autologous BMMNC injected in the ipsilateral MCA
|
|
Aktiv komparator: Control
Patients randomised in this group received standard care only
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in National Institutes of Health Stroke Scale
Tidsramme: 6 month
|
increase in National Institutes of Health Stroke Scale more than / equal to 4 points
|
6 month
|
|
symptomatic intracranial hemorrhage
Tidsramme: 6 month
|
6 month
|
|
|
new ischemic lesion
Tidsramme: 6 month
|
6 month
|
|
|
Death
Tidsramme: 6 month
|
6 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
modified rankin score
Tidsramme: 6 months
|
A modified rankin score of 0-1 in patients with National Institutes of Health Stroke Scale of 8-14 at the admission and modified rankin score of 0-2 in patients with National Institutes of Health Stroke Scale >14 at the admission.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Vivek Gupta, DM, Postgraduate Institute of Medical Education and Research
- Ledende efterforsker: Vikas Bhatia, DM, Postgraduate Institute of Medical Education and Research
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
- Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.
- Battistella V, de Freitas GR, da Fonseca LM, Mercante D, Gutfilen B, Goldenberg RC, Dias JV, Kasai-Brunswick TH, Wajnberg E, Rosado-de-Castro PH, Alves-Leon SV, Mendez-Otero R, Andre C. Safety of autologous bone marrow mononuclear cell transplantation in patients with nonacute ischemic stroke. Regen Med. 2011 Jan;6(1):45-52. doi: 10.2217/rme.10.97.
- Suarez-Monteagudo C, Hernandez-Ramirez P, Alvarez-Gonzalez L, Garcia-Maeso I, de la Cuetara-Bernal K, Castillo-Diaz L, Bringas-Vega ML, Martinez-Aching G, Morales-Chacon LM, Baez-Martin MM, Sanchez-Catasus C, Carballo-Barreda M, Rodriguez-Rojas R, Gomez-Fernandez L, Alberti-Amador E, Macias-Abraham C, Balea ED, Rosales LC, Del Valle Perez L, Ferrer BB, Gonzalez RM, Bergado JA. Autologous bone marrow stem cell neurotransplantation in stroke patients. An open study. Restor Neurol Neurosci. 2009;27(3):151-61. doi: 10.3233/RNN-2009-0483.
- Savitz SI, Misra V, Kasam M, Juneja H, Cox CS Jr, Alderman S, Aisiku I, Kar S, Gee A, Grotta JC. Intravenous autologous bone marrow mononuclear cells for ischemic stroke. Ann Neurol. 2011 Jul;70(1):59-69. doi: 10.1002/ana.22458.
- Friedrich MA, Martins MP, Araujo MD, Klamt C, Vedolin L, Garicochea B, Raupp EF, Sartori El Ammar J, Machado DC, Costa JC, Nogueira RG, Rosado-de-Castro PH, Mendez-Otero R, Freitas GR. Intra-arterial infusion of autologous bone marrow mononuclear cells in patients with moderate to severe middle cerebral artery acute ischemic stroke. Cell Transplant. 2012;21 Suppl 1:S13-21. doi: 10.3727/096368912x612512.
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. juli 2015
Primær færdiggørelse (Faktiske)
1. december 2016
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
7. marts 2017
Først indsendt, der opfyldte QC-kriterier
14. marts 2017
Først opslået (Faktiske)
15. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Nekrose
- Hjerte-kar-sygdomme
- Karsygdomme
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Hjerneiskæmi
- Hjerneinfarkt
- Cerebrale arterielle sygdomme
- Intrakranielle arterielle sygdomme
- Infarkt
- Slag
- Iskæmisk slagtilfælde
- Iskæmi
- Cerebralt infarkt
- Infarkt, mellemhjernearterie
Andre undersøgelses-id-numre
- PGIMER RADIOLOGY
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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