NCT03176498

Brief Summary

This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 5, 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

May 23, 2017

Last Update Submit

April 22, 2026

Conditions

Cerebral Infarction

Keywords

cerebral Infarctionumbilical cord mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

  • Motor function analysis

    Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb \>60, and total score \>90 is considered good recovery.

    6 months

Secondary Outcomes (3)

  • Neurological deficits analysis

    6 months

  • Limb motor function analysis

    6 months

  • Barthel Index analysis

    6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Basic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells

Biological: Allogeneic umbilical cord mesenchymal stem cellDrug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium

Control group

PLACEBO COMPARATOR

Basic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Placebo：saline

Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium

Interventions

Allogeneic umbilical cord mesenchymal stem cellBIOLOGICAL

Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)

Experimental group
Aspirin Enteric-coated Tablets & Atorvastatin CalciumDRUG

Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

Control groupExperimental group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proved cerebral infarction by CT or MRI.
  • no cerebrovascular disease before
  • signed informed consent form

You may not qualify if:

  • serious body and intracranial lesions (tumor, infection, etc.)
  • patients repeated cerebral infarction attacks
  • multi-foci of cerebral infarction
  • history of drug dependence and mental disease
  • disturbance of consciousness and non-compliance patients
  • subjects who are HIV positive
  • pregnant or lactation
  • donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive
  • subjects/ donor: alcoholism, drug addicts or mental disease

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

Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Wulan

    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

May 23, 2017

First Posted

June 5, 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)