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Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients

NCT04093336 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-04-18

No results posted yet for this study

Summary

This is a placebo controlled, randomized, double blinded study including Phase 1 and Phase 2. Phase I study is a safety assessment and Phase 2 study is incline to assess effectiveness of MSCs. Potential subjects must be screened and consented before enrolled.

The primary objective of this study is to determine the effects of early intravenous infusion of allogeneic human umbilical cord mesenchymal stem cells (HucMSCs or MSCs used in the following section) for patients with acute ischemic stroke. Eligible patients will receive a single dose of MSCs or placebo within 24 hours after stroke. Patients will be followed for 2 years post infusion for safety and efficacy (change in neurological symptoms and quality of life). Assessments will occur during transplantation and at 3,7, 14 days and1,3, 6, 12, 18 and 24 months after infusions of stem cells.

Conditions

  • Infarction, Middle Cerebral Artery
  • Infarction, Anterior Cerebral Artery
  • Cerebral Infarction
  • Stroke, Ischemic
  • Acute Stroke
  • Brain Infarction
  • Infarction, PCA
  • Infarction, Posterior Circulation, Brain

Interventions

BIOLOGICAL

human umbilical cord mesenchymal stem cells

The MSCs was intravenous transplanted to acute cerebral infarction patients as a single dose.

BIOLOGICAL

Placebo

Placebo

OTHER

standardized treatment

standardized treatment

Sponsors & Collaborators

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Gang Li, Doctor · Shanghai East Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-13
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04093336 on ClinicalTrials.gov