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

NCT ID: NCT05292625

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2023-11-30

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

UC-MSC infusion via intravenous route

Intervention Type: BIOLOGICAL

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

standard stroke treatment and rehabilitation therapy

Intervention Type: OTHER

Each patient can receive up to 30 days of 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

Group Type: EXPERIMENTAL

UC-MSC infusion via intrathecal route

Intervention Type: BIOLOGICAL

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

standard stroke treatment and rehabilitation therapy

Intervention Type: OTHER

Each patient can receive up to 30 days of rehabilitation therapy

control arm

standard stroke treatment and rehabilitation therapy

Group Type: OTHER

standard stroke treatment and rehabilitation therapy

Intervention Type: OTHER

Each patient can receive up to 30 days of rehabilitation therapy

Interventions

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

standard stroke treatment and rehabilitation therapy

Each patient can receive up to 30 days of rehabilitation therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liem T Nguyen, Prof

Role: PRINCIPAL_INVESTIGATOR

Vinmec Research Institute of Stem Cell and Gene Technology

Locations

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Hanoi, Vietnam

Countries

Vietnam

References

Hoang VT, Le DS, Hoang DM, Phan TTK, Ngo LAT, Nguyen TK, Bui VA, Nguyen Thanh L. Impact of tissue factor expression and administration routes on thrombosis development induced by mesenchymal stem/stromal cell infusions: re-evaluating the dogma. Stem Cell Res Ther. 2024 Feb 27;15(1):56. doi: 10.1186/s13287-023-03582-3.

Reference Type: DERIVED

PMID: 38414067 (View on PubMed)

Other Identifiers

VinmecISC1809

Identifier Type: -

Identifier Source: org_study_id