Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells).
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Detailed description
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.
Interventions
- Drug Placebo
Intravenous injection of placebo - Drug IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)
Intravenous injection of IxCell hUC-MSC-S
Primary outcome measures
- Fugl-Meyer Assessment motor score [Time frame: 12 months]
Secondary outcome measures (4)
- Modified Rankin Scale [Time frame: 12 months]
- National Institutes of Health Stroke Scale [Time frame: 12 months]
- Barthel Index [Time frame: 12 months]
- Mini-Mental State Examination [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07197606 · LC-MSC-IS25001