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

NCT07197606 | Not Yet Recruiting Phase 2

• 1 other identifier: LC-MSC-IS25001
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment motor score

  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.

  12 months

Secondary Outcomes (4)

• Modified Rankin Scale

  12 months

• National Institutes of Health Stroke Scale

  12 months

• Barthel Index

  12 months

• Mini-Mental State Examination

  12 months

Study Arms (2)

MSCs treatment

EXPERIMENTAL

Intravenous injection of mesenchymal stem cells

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

Placebo

PLACEBO COMPARATOR

Intravenous injection of placebo

Drug: Placebo

Interventions

Placebo DRUG

Intravenous injection of placebo

Placebo

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

Intravenous injection of IxCell hUC-MSC-S

MSCs treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤70 years, regardless of gender.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai IxCell Biotechnology Co., LTD: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ming Xiao, PHD

CONTACT

+86 21 68911597; xiaoming@ixcell.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual Participant Data (IPD) is expected to be available upon trial completion on December 31, 2027, and this availability is anticipated to last until December 31, 2035.
• Access Criteria: Relevant personnel who have submitted an application and obtained approval and authorization from the investigator(s) and sponsor(s) will receive the subjects' demographic data, scoring data, and safety data-with such information to be provided and transmitted by the investigator(s) to the authorized personnel.

Locations

CN (1)