NCT03186456

Brief Summary

The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
12mo left

Started Dec 2026

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
9.6 years until next milestone

Study Start

First participant enrolled

December 31, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 23, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

June 6, 2017

Last Update Submit

April 22, 2026

Conditions

Cerebral Infarction

Keywords

acute cerebral infarctionumbilical cord mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

  • Treatment related-adverse events counting

    patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells

    26 weeks

Secondary Outcomes (3)

  • Modified Rankin Scale

    26 weeks

  • Barthel activities of daily living (ADL) Index

    26 weeks

  • NIH stroke scale (NIHSS)

    26 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1\*10\^6/kg

Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)Drug: Aspirin Tablet

Group 2

PLACEBO COMPARATOR

Aspirin Tablet, 100mg/d; Placebo

Drug: Aspirin Tablet

Interventions

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)BIOLOGICAL

Allogeneic umbilical cord mesenchymal stem cells will transfusion into by forearm intravenous transplantation, 0.5 - 1 \*10\^6/kg. once a month, total 3 times.

Group 1
Aspirin TabletDRUG

Drug: Aspirin Tablet, 100 mg/d

Group 1Group 2

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient within 2 weeks onset of symptoms.
  • Symptoms and signs of clinically definite acute cerebral infarction patients.
  • CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
  • Signed informed consent after understanding all possible benefits and harm.

You may not qualify if:

  • allergic to basic drug
  • with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
  • tumor, injury, and parasites caused cerebral embolism
  • rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
  • subject is processing thrombolytic therapy
  • subject is pregnancy and of childbearing potential or breast feeding
  • participate in any other clinical trial in last 3 months
  • bleeding tendency patient; severe bleeding tendency in last 3 month
  • with gastric duodenal ulcer
  • participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
  • participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs
  • participants: alcoholism, drug addicted, or other situations may complicated the results
  • under other therapy that possibly influence MSC security or efficacy
  • investigator supposes not suitable to participate this clinical trail

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, 010065, China

Location

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Temuqile

    Inner Mongolia International Mongolian Hospital

    STUDY DIRECTOR

  • Lei Guo, Dr.

    China-Japan Union Hospital, Jilin University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 14, 2017

Study Start (Estimated)

December 31, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 23, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)