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Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

NCT01849887 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-01-22

No results posted yet for this study

Summary

Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.

Conditions

Interventions

BIOLOGICAL

bone marrow-derived mesenchymal stem cells

bone marrow-derived mesenchymal stem cells

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Steve Cramer, MD · Univ Calif Irvine

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
2016-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01849887 on ClinicalTrials.gov