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

Sponsor

Vinmec Research Institute of Stem Cell and Gene Technology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05292625

Collaborator

(none)

Enrollment

Location

Arms

22.6

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 15, 2021

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Jun 2, 2023

Arms and Interventions

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
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

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

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

Outcome Measures

Primary Outcome Measures

Adverse events and serious adverse events [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

National Institutes of Health Stroke Scale (NIHSS) score [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
Functional Independence Measure (FIM) score [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
Modified Ashworth Scale [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)
Fine motor skills (FMI) score [up to the 12-month period following treatment]
Fine motor skills (FMI) scores range from 0 to 58
Short Form 36 items (SF-36) score [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.