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

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
UC-MSC infusion via intravenous route
UC-MSC infusion via intrathecal route
standard stroke treatment and rehabilitation therapy
Sponsored by
Vinmec Research Institute of Stem Cell and Gene Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, umbilical cord mesenchymal stem cells, Neurological Complication

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Vinmec Research Institute of Stem Cell and Gene TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

UC-MSC infusion via intravenous route

UC-MSC infusion via intrathecal route

control arm

Arm Description

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

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

standard stroke treatment and rehabilitation therapy

Outcomes

Primary Outcome Measures

Adverse events and serious adverse events
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

National Institutes of Health Stroke Scale (NIHSS) score
National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating more severe neurological deficit
Functional Independence Measure (FIM) score
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
Modified Ashworth Scale
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)
Fine motor skills (FMI) score
Fine motor skills (FMI) scores range from 0 to 58
Short Form 36 items (SF-36) score
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

Full Information

First Posted
March 14, 2022
Last Updated
April 13, 2023
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05292625
Brief Title
Stem Cell Infusion in the Treatment of Patients With Neurological Complications After Ischemic Stroke
Official Title
Outcomes of Umbilical Cord Blood-derived Mesenchymal Stem Cell Infusion in Patients With Neurological Complications After Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic Stroke, umbilical cord mesenchymal stem cells, Neurological Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UC-MSC infusion via intravenous route
Arm Type
Experimental
Arm Description
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
Arm Title
UC-MSC infusion via intrathecal route
Arm Type
Experimental
Arm Description
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
Arm Title
control arm
Arm Type
Other
Arm Description
standard stroke treatment and rehabilitation therapy
Intervention Type
Biological
Intervention Name(s)
UC-MSC infusion via intravenous route
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
UC-MSC infusion via intrathecal route
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
standard stroke treatment and rehabilitation therapy
Intervention Description
Each patient can receive up to 30 days of rehabilitation therapy
Primary Outcome Measure Information:
Title
Adverse events and serious adverse events
Description
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
Time Frame
up to the 12-month period following treatment
Secondary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS) score
Description
National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating more severe neurological deficit
Time Frame
up to the 12-month period following treatment
Title
Functional Independence Measure (FIM) score
Description
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
Time Frame
up to the 12-month period following treatment
Title
Modified Ashworth Scale
Description
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)
Time Frame
up to the 12-month period following treatment
Title
Fine motor skills (FMI) score
Description
Fine motor skills (FMI) scores range from 0 to 58
Time Frame
up to the 12-month period following treatment
Title
Short Form 36 items (SF-36) score
Description
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
Time Frame
up to the 12-month period following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liem T Nguyen, Prof
Phone
0986565015
Email
v.liemnt@vinmec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kien T Nguyen, MsC
Phone
0386958552
Email
v.kiennt25@vinmec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, Prof
Organizational Affiliation
Vinmec Research Institute of Stem Cell and Gene Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nguyen T Liem, Prof

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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