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

Shanghai IxCell Biotechnology

Status and phase: Not yet enrolling; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07197606

LC-MSC-IS25001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups, including a placebo group

MSCs treatment

Experimental group

Description:

Intravenous injection of mesenchymal stem cells

Treatment:

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

Placebo

Placebo Comparator group

Description:

Intravenous injection of placebo

Treatment:

Drug: Placebo