Clinical trial NCT05292625: Stem Cell Infusion in the Treatment of Patients with Neurological Sequelae After Ischemic Stroke
Official title: Outcomes of Umbilical Cord -derived Mesenchymal Stem Cell Infusion in Patients with Neurological Sequelae After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
umbilical cord mesenchymal stem cells
Neurological Complication
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Adverse events and serious adverse events
timeFrame: up to the 12-month period following treatment
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: up to the 12-month period following treatment
measure: Functional Independence Measure (FIM) score
timeFrame: up to the 12-month period following treatment
measure: Modified Ashworth Scale
timeFrame: up to the 12-month period following treatment
measure: Fine motor skills (FMI) score
timeFrame: up to the 12-month period following treatment
measure: Short Form 36 items (SF-36) score
timeFrame: up to the 12-month period following treatment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Vinmec Research Institute of Stem Cell and Gene Technology
name: Liem T Nguyen, Prof
role: PRINCIPAL_INVESTIGATOR
References: