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Stem Cell Infusion in the Treatment of Patients With Neurological Complications After Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT05292625
Recruitment Status : Recruiting
First Posted : March 23, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

Brief Summary:
This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) in combination with standard neurological complications after ischemic stroke treatment in Vietnam.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: UC-MSC infusion via intravenous route Biological: UC-MSC infusion via intrathecal route Other: standard stroke treatment and rehabilitation therapy Phase 1 Phase 2

Detailed Description:
Stroke is the second leading cause of death behind ischemic heart disease worldwide. Traditional treatments have some limitations whereas preclinical data suggest that stem cell therapy is a promising regenerative medical treatment given the limited capacity of the central nervous system for self-repairs after ischemic stroke. Previous studies have shown that umbilical cord blood-derived Mesenchymal stem cell (UC-MSC) infusion improves the outcomes of several neurological damage conditions, including stroke. These results encouraged us to initiate the phase I/II clinical trial aiming to evaluate the safety and the efficiency of UC-MSC transplantation in the treatment of patients with neurological complications after ischemic stroke. This case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between 2021 and 2023. In this trial, 48 patients with neurological complications after ischemic stroke will be enrolled into 3 groups: UC-MSC infusion via intravenous route group (16), UC-MSC infusion via intrathecal administration route group (16), and control group (16). The UC-MSC group (IV/intrathecal) will receive two doses of thawed UC-MSC product at 1.5x106 cells/kg patient body weight with an intervention interval of three months. The primary outcome measures will include the incidence of prespecified administration-associated adverse events (AEs) and serious adverse events (SAEs). The potential efficacy will be measured using these scales including National Institutes of Health Stroke Scale-NIHSS, Functional Independence Measure -FIM, Modified Ashworth Scale-MAS, Fine motor skills-FMS, 36-Item Short Form Survey -SF-36. The clinical evaluation will be conducted at baseline and 3-, 6- and 12-months post-intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Outcomes of Umbilical Cord Blood-derived Mesenchymal Stem Cell Infusion in Patients With Neurological Complications After Ischemic Stroke
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : June 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arm Intervention/treatment
Experimental: UC-MSC infusion via intravenous route
1.5 x 10^6 umbilical Cord Mesenchymal Stem Cells per body kg will be infusion via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with standard frailty treatment and supplementary medication
Biological: UC-MSC infusion via intravenous route
Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1.5 million cells/kg patient body weight via the intravenous (IV) route with a 3-month intervening interval

Other: standard stroke treatment and rehabilitation therapy
Each patient can receive up to 30 days of rehabilitation therapy

Experimental: UC-MSC infusion via intrathecal route
1.5 x 10^6 umbilical Cord Mesenchymal Stem Cells per body kg will be infusion via the intrathecal at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with standard frailty treatment and supplementary medication
Biological: UC-MSC infusion via intrathecal route
Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1.5 million cells/kg patient body weight via the intrathecal route with a 3-month intervening interval

Other: standard stroke treatment and rehabilitation therapy
Each patient can receive up to 30 days of rehabilitation therapy

control arm
standard stroke treatment and rehabilitation therapy
Other: standard stroke treatment and rehabilitation therapy
Each patient can receive up to 30 days of rehabilitation therapy




Primary Outcome Measures :
  1. Adverse events and serious adverse events [ Time Frame: up to the 12-month period following treatment ]
    To assess safety, the number of AEs or SAEs during stem cell administration (72 h) at 3 months, 6 months and 12 months after discharge will be evaluated


Secondary Outcome Measures :
  1. National Institutes of Health Stroke Scale (NIHSS) score [ Time Frame: up to the 12-month period following treatment ]
    National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating more severe neurological deficit

  2. Functional Independence Measure (FIM) score [ Time Frame: up to the 12-month period following treatment ]
    Functional Independence Measure (FIM) is a widely accepted functional assessment measure used during inpatient rehabilitation with the possible total score ranging from 18 (lowest) to 126 (highest) level of independence

  3. Modified Ashworth Scale [ Time Frame: up to the 12-month period following treatment ]
    The modified Ashworth scale purpose is to grade muscle spasticity. The scale is from 0 (No increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension)

  4. Fine motor skills (FMI) score [ Time Frame: up to the 12-month period following treatment ]
    Fine motor skills (FMI) scores range from 0 to 58

  5. Short Form 36 items (SF-36) score [ Time Frame: up to the 12-month period following treatment ]
    Short Form 36 items (SF-36) consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Age: from 40 to 75 years.
  • Gender: either sex
  • Patients have been discharged/patients who are hospitalized but their general condition is stable:

    • No need for vasopressor drugs
    • No need for mechanical ventilation or oxygen support
    • No signs of infection (fever, high WBC, high CRP/Procalcitonin)
    • No kidney failure, liver failure, heart failure.
  • Time from onset to study participation ≤ 24 months
  • National Institutes of Health Stroke Scale (NIHSS) score >=5
  • Agree to participate in the study

Exclusion Criteria:

  • Hematologic cause of stroke
  • There is evidence of active infections, failure of heart, lung, liver, or kidney, respiratory distress syndrome, anemia, clotting disorder
  • Cancer.
  • Pregnancy.
  • Tracheostomy, coma, complete quadriplegia, vegetative.

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): NCT05292625


Contacts
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Contact: Liem T Nguyen, Prof 0986565015 v.liemnt@vinmec.com
Contact: Kien T Nguyen, MsC 0386958552 v.kiennt25@vinmec.com

Locations
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Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 100000
Contact: Nguyen T Liem, Prof         
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology
Investigators
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Principal Investigator: Liem T Nguyen, Prof Vinmec Research Institute of Stem Cell and Gene Technology
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Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT05292625    
Other Study ID Numbers: VinmecISC1809
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
Ischemic Stroke
umbilical cord mesenchymal stem cells
Neurological Complication
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis