Stem Cell Infusion in the Treatment of Patients with Neurological Sequelae After Ischemic Stroke

Outcomes of Umbilical Cord -derived Mesenchymal Stem Cell Infusion in Patients with Neurological Sequelae After Ischemic Stroke

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Biological: UC-MSC infusion via intravenous route; Other: standard stroke treatment and rehabilitation therapy; Biological: UC-MSC infusion via intrathecal route

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Vinmec Research Institute of Stem Cell and Gene Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to the 12-month period following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to the 12-month period following treatment
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	up to the 12-month period following treatment
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)	up to the 12-month period following treatment
Fine motor skills (FMI) score	Fine motor skills (FMI) scores range from 0 to 58	up to the 12-month period following treatment
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	up to the 12-month period following treatment

Collaborators and Investigators

• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
• Investigators: Principal Investigator: Liem T Nguyen, Prof, Vinmec Research Institute of Stem Cell and Gene Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic Stroke; umbilical cord mesenchymal stem cells; Neurological Complication
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: VinmecISC1809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No