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Ischemic StrokePhase 1/2NCT05292625

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

A Phase 1/2 study testing UC-MSC infusion via intravenous route, UC-MSC infusion via intrathecal route and standard stroke treatment and rehabilitation therapy in people with Ischemic Stroke, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Ischemic Stroke
What is being tested?
UC-MSC infusion via intravenous route, UC-MSC infusion via intrathecal route and standard stroke treatment and rehabilitation therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteVietnam
Study dates
7 Jul 2020to 30 Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Vietnam1 site

  • Vinmec Research Institute of Stem Cell and Gene Technology

    Hanoi, Hanoi, 100000

Other trials in Vietnam

About this study

Official title: Outcomes of Umbilical Cord -derived Mesenchymal Stem Cell Infusion in Patients with Neurological Sequelae After Ischemic Stroke

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.

Read the 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
Being tested
UC-MSC infusion via intravenous route, UC-MSC infusion via intrathecal route, standard stroke treatment and rehabilitation therapy
Keywords
Ischemic Stroke, umbilical cord mesenchymal stem cells, Neurological Complication
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UC-MSC infusion via intravenous routeBiological

    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 intrathecal routeBiological

    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 therapyOther

    Each patient can receive up to 30 days of rehabilitation therapy

Study groups in NCT05292625
Study groupRoleWhat they receive
UC-MSC infusion via intravenous routeExperimental1.5 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
Receives: Biological: UC-MSC infusion via intravenous route; Other: standard stroke treatment and rehabilitation therapy
UC-MSC infusion via intrathecal routeExperimental1.5 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
Receives: Biological: UC-MSC infusion via intrathecal route; Other: standard stroke treatment and rehabilitation therapy
control armOtherstandard stroke treatment and rehabilitation therapy
Receives: Other: standard stroke treatment and rehabilitation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to the 12-month period following treatment

Secondary outcomes (5)

  1. National Institutes of Health Stroke Scale (NIHSS) score

    National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating more severe neurological deficit

    Measured: up to the 12-month period following treatment

  2. Functional Independence Measure (FIM) score

    Functional Independence Measure (FIM) is a widely accepted functional assessment measure used during inpatient rehabilitation with the possible total score ranging from 18 (lowest) to 126 (highest) level of independence

    Measured: up to the 12-month period following treatment

  3. Modified Ashworth Scale

    The modified Ashworth scale purpose is to grade muscle spasticity. The scale is from 0 (No increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension)

    Measured: up to the 12-month period following treatment

  4. Fine motor skills (FMI) score

    Fine motor skills (FMI) scores range from 0 to 58

    Measured: up to the 12-month period following treatment

  5. Short Form 36 items (SF-36) score

    Short Form 36 items (SF-36) consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

    Measured: up to the 12-month period following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start7 Jul 2020
  3. Primary completion30 Dec 2022
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292625
Sponsor's protocol ID
VinmecISC1809
Status last verified
Jun 2024
First submitted
14 Mar 2022
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41277536

  • 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.

    PubMed 38414067

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing UC-MSC infusion via intravenous route, UC-MSC infusion via intrathecal route and standard stroke treatment and rehabilitation therapy in people with Ischemic Stroke, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events and serious adverse events (time frame: up to the 12-month period following treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05292625, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.

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