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

NCT05292625 | Completed Phase 1

• 1 other identifier: VinmecISC1809
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; umbilical cord mesenchymal stem cells; Neurological Complication

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events

  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

  up to the 12-month period following treatment

Secondary Outcomes (5)

• National Institutes of Health Stroke Scale (NIHSS) score

  up to the 12-month period following treatment

• Functional Independence Measure (FIM) score

  up to the 12-month period following treatment

• Modified Ashworth Scale

  up to the 12-month period following treatment

• Fine motor skills (FMI) score

  up to the 12-month period following treatment

• Short Form 36 items (SF-36) score

  up to the 12-month period following treatment

Study Arms (3)

UC-MSC infusion via intravenous route

EXPERIMENTAL

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

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

UC-MSC infusion via intrathecal route

EXPERIMENTAL

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

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

control arm

OTHER

standard stroke treatment and rehabilitation therapy

Other: standard stroke treatment and rehabilitation therapy

Interventions

UC-MSC infusion via intravenous route 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

UC-MSC infusion via intravenous route

UC-MSC infusion via intrathecal route 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

UC-MSC infusion via intrathecal route

standard stroke treatment and rehabilitation therapy OTHER

Each patient can receive up to 30 days of rehabilitation therapy

UC-MSC infusion via intrathecal route; UC-MSC infusion via intravenous route; control arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Hanoi, 100000, Vietnam

Location

Related Publications (2)

• Nguyen LT, Nguyen TTN, Nguyen KT, Phung LN, Hoang VT, Phan TTK, Van Pham M, Nguyen ATP, Van Ngo D, Van Nguyen A, Van Nguyen C. Intrathecal versus intravenous umbilical cord mesenchymal stem cells for ischemic stroke sequelae. Stem Cells Transl Med. 2025 Nov 24;14(12):szaf063. doi: 10.1093/stcltm/szaf063.

  PMID: 41277536 DERIVED

• 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.

  PMID: 38414067 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Liem T Nguyen, Prof

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: July 7, 2020
• Primary Completion: December 30, 2022
• Study Completion: November 30, 2023
• Last Updated: January 6, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)