Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 1802 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02178657
Recruitment Status : Recruiting
First Posted : July 1, 2014
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Francisco Moniche, Hospitales Universitarios Virgen del Rocío

Brief Summary:
This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Autologous bone marrow mononuclear cell intra-arterial injection Phase 2

Detailed Description:
This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Bone marrow transplantation low dose
Intra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram)
Drug: Autologous bone marrow mononuclear cell intra-arterial injection
Experimental: Bone marrow transplantation high dose
Intra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram)
Drug: Autologous bone marrow mononuclear cell intra-arterial injection
No Intervention: Control



Primary Outcome Measures :
  1. Disability [ Time Frame: 6 months ]
    Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 24 months ]

Other Outcome Measures:
  1. Functional outcomes [ Time Frame: 6 months ]
    Functional outcome measure by National Institute of Health Stroke Scale and Barthel at 6 months

  2. Infarct volume [ Time Frame: 6 months ]
    Infarct volume change between baseline (DWI) and 6 months (FLAIR)

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 months ]
  4. Number of Participants with new-onset seizures as a Measure of Safety and Tolerability [ Time Frame: 6 months ]
  5. Functional outcomes [ Time Frame: 6 months ]
    Categorical shift in mRS ordinal (0-6) scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with middle cerebral artery (MCA) acute ischemic stroke.
  • Time of stroke onset is known and treatment can be started between day 1 and 7 of onset.
  • DWI-MRI has reliably shown acute MCA ischemic lesions
  • Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability
  • National Institute of Health Stroke Scale score of 6-20 at inclusion
  • Age 18-80 years
  • Written informed consent has been obtained

Exclusion Criteria:

  • Hemorrhagic stroke or symptomatic hemorrhagic transformation
  • Lacunar infarction
  • Preocclusive stenosis or total occlusion of ipsilateral carotid artery
  • Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema
  • Decrease of consciousness with a Glasgow Coma Scale of <8 points
  • Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma
  • Contraindication for MRI or for bone marrow harvest
  • Previous diagnosis of neurodegenerative disease
  • Acute heart failure
  • Hepatic or renal dysfunction (creatinine >2mg/dL)
  • Coagulopathy
  • Severe co-morbidity
  • Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding
  • Modified Rankin Score (mRS) before stroke of ≥2
  • Participation in any clinical trial in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178657


Contacts
Layout table for location contacts
Contact: Natividad Cuende, MD, MPH, PhD (+34) 955048366 natividad.cuende.sspa@juntadeandalucia.es

Locations
Layout table for location information
Spain
Hospital Universitario Puerta del Mar Recruiting
Cadiz, Spain, 11009
Contact: Raul Espinosa Rosso, MD       raulespinosarosso@gmail.com   
Principal Investigator: Raul Espinosa Rosso, MD         
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain, 14004
Contact: Roberto Valverde Moyano, MD       rvalverdemoyano@hotmail.com   
Hospitales Universitarios Virgen del Rocio Recruiting
Seville, Spain, 41013
Contact: Francisco Moniche, MD, PhD    +34 955012593    pmoniche@gmail.com   
Hospitales Universitarios Virgen Macarena Recruiting
Seville, Spain, 41071
Contact: Miguel Ángel Gamero, MD    (+34) 955008681    mangel.gamero.sspa@juntadeandalucia.es   
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies
Investigators
Layout table for investigator information
Principal Investigator: Francisco Moniche, MD, PhD Hospitales Universitarios Virgen del Rocio

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Francisco Moniche, Neurologist, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT02178657     History of Changes
Obsolete Identifiers: NCT02290483
Other Study ID Numbers: EudraCT 2013-002135-15
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Keywords provided by Francisco Moniche, Hospitales Universitarios Virgen del Rocío:
Stroke
Cell therapy
Bone marrow

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia