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

NCT ID: NCT07197606

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MSCs treatment

Intravenous injection of mesenchymal stem cells

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Intravenous injection of IxCell hUC-MSC-S

Placebo

Intravenous injection of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous injection of placebo

Interventions

Placebo

Intravenous injection of placebo

Intervention Type: DRUG

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

Intravenous injection of IxCell hUC-MSC-S

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai IxCell Biotechnology Co., LTD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Ming Xiao, PHD

Role: CONTACT

xiaoming@ixcell.com.cn

+86 21 68911597

Facility Contacts

Gaoting Ma, MD

Role: primary

demo_doctor@163.com

+86 18301579891

Other Identifiers

LC-MSC-IS25001

Identifier Type: -

Identifier Source: org_study_id