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NCT Number: NCT07197606

Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke

The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

This study aims to further evaluate the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of stroke. Eligible participants will be randomized to receive either intravenous infusions of hUC-MSCs or a matching placebo. Over the 12-month study period, participants will be required to attend regular clinic visits for comprehensive neurological assessments, including the Fugl-Meyer Assessment (FMA), Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Mini-Mental State Examination (MMSE), as well as vascular imaging studies and biomarker analyses. Additionally, participants (or their caregivers, where applicable) will be instructed to consistently document neurological symptoms, functional activities, and the use of any rehabilitation medications or assistive devices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years and ≤70 years, regardless of gender.
  • 14 to 90 days after ischemic stroke.
  • Clinical diagnosis of anterior circulation ischemic stroke.
  • National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score <2 points.
  • It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.

Exclusion criteria

  • People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.
  • Intracranial hemorrhagic conditions.
  • Pre-stroke mRS score >1.
  • Severe cardiovascular disease.
  • Severe pulmonary diseases.

Treatment and study plan

Placebo

Drug

Intravenous injection of placebo

IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)

Drug

Intravenous injection of IxCell hUC-MSC-S

Primary outcomes

  1. Fugl-Meyer Assessment motor score

    Time frame: 12 months

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based scale used to evaluate motor impairment. Its motor score, which ranges from 0 to 100, serves as a key parameter for quantifying motor recovery, where a higher score indicates better motor function.

Secondary outcomes

  1. Modified Rankin Scale

    Time frame: 12 months

    The Modified Rankin Scale (mRS) is designed to evaluate the degree of dependence in daily activities rather than specific impairments. The mRS is a simple ordinal scale ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death. A lower score on the scale signifies a better level of independence and a lower degree of disability.

  2. National Institutes of Health Stroke Scale

    Time frame: 12 months

    The National Institutes of Health Stroke Scale (NIHSS) is designed to evaluate the effects of a stroke on key functional domains such as consciousness, vision, motor strength, sensation, and language.The NIHSS score ranges from 0 to 42, with a higher score indicating more severe neurological deficits.

  3. Barthel Index

    Time frame: 12 months

    The Barthel Index (BI) is commonly employed to evaluate functional disability and monitor rehabilitation progress in patients with chronic conditions or following events such as stroke. The total score ranges from 0 to 100, with a higher score indicating a greater degree of functional independence.

  4. Mini-Mental State Examination

    Time frame: 12 months

    The Mini-Mental State Examination (MMSE) is a standardized screening tool designed to provide a quick assessment of an individual's global cognitive function.The total score ranges from 0 to 30, with a higher score indicating better cognitive performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Xiao, PHD

CONTACT

[email protected]

+86 21 68911597

Sponsors and collaborators

Lead sponsor

Shanghai IxCell Biotechnology Co., LTD

Other

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-S in Patients With Ischemic Stroke in the Recovery Phase

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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