Stem Cell Infusion in the Treatment of Patients with Neurological Sequelae After Ischemic Stroke
- Conditions
- Ischemic Stroke
- Interventions
- Other: standard stroke treatment and rehabilitation therapyBiological: UC-MSC infusion via intrathecal routeBiological: UC-MSC infusion via intravenous route
- Registration Number
- NCT05292625
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control arm standard stroke treatment and rehabilitation therapy standard stroke treatment and rehabilitation therapy UC-MSC infusion via intrathecal route 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 UC-MSC infusion via intravenous route standard stroke treatment and rehabilitation therapy 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 UC-MSC infusion via intrathecal route standard stroke treatment and rehabilitation therapy 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 UC-MSC infusion via intravenous route 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method Fine motor skills (FMI) score up to the 12-month period following treatment Fine motor skills (FMI) scores range from 0 to 58
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
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
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)
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
Trial Locations
- Locations (1)
Vinmec Research Institute of Stem Cell and Gene Technology
🇻🇳Hanoi, Vietnam