Outcomes of Umbilical Cord -derived Mesenchymal Stem Cell Infusion in Patients with Neurological Sequelae After Ischemic Stroke
Overview
- Phase
- Phase 1
- Intervention
- UC-MSC infusion via intravenous route
- Conditions
- Ischemic Stroke
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Adverse events and serious adverse events
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
- •Pregnancy.
- •Tracheostomy, coma, complete quadriplegia, vegetative.
Arms & Interventions
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
Intervention: 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
Intervention: standard stroke treatment and rehabilitation therapy
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
Intervention: 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
Intervention: standard stroke treatment and rehabilitation therapy
control arm
standard stroke treatment and rehabilitation therapy
Intervention: standard stroke treatment and rehabilitation therapy
Outcomes
Primary Outcomes
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 Outcomes
- Fine motor skills (FMI) score(up to the 12-month period following treatment)
- Functional Independence Measure (FIM) score(up to the 12-month period following treatment)
- Short Form 36 items (SF-36) score(up to the 12-month period following treatment)
- Modified Ashworth Scale(up to the 12-month period following treatment)
- National Institutes of Health Stroke Scale (NIHSS) score(up to the 12-month period following treatment)