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

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ischemic Stroke

Treatments: Biological: UC-MSC infusion via intravenous route; Other: standard stroke treatment and rehabilitation therapy; Biological: UC-MSC infusion via intrathecal route

Study type: Interventional

Funder types: Other

Identifiers

NCT05292625

VinmecISC1809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

UC-MSC infusion via intravenous route

Experimental group

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

Treatment:

Other: standard stroke treatment and rehabilitation therapy

Biological: UC-MSC infusion via intravenous route

UC-MSC infusion via intrathecal route

Experimental group

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

Treatment:

Biological: UC-MSC infusion via intrathecal route

Other: standard stroke treatment and rehabilitation therapy

control arm

Other group

Description:

standard stroke treatment and rehabilitation therapy

Treatment:

Other: standard stroke treatment and rehabilitation therapy