A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke

Completed · Phase 1/Phase 2

Conditions studied: Ischemic Stroke

In brief

The purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.

Key facts

Study ID

NCT01297413

Run by

Stemedica Cell Technologies, Inc.

People needed

38

Starts

2011-02-01

Expected to finish

2018-11-15

Last updated by the study team

2018-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of ischemic stroke for longer than 6 months
• Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
• No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
• NIHSS score between 6-20
• Life expectancy greater than 12 months
• Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
• Adequate organ function as defined by the following criteria:

You may not qualify if…

• History of uncontrolled seizure disorder
• History of cancer within the past 5 years.
• History of cerebral neoplasm
• Positive for hepatitis B, C or HIV
• Myocardial infarction withing six months of study entry
• Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
• Allergies to Bovine or Porcine products

Where it is running

• Mercy Gilbert and Chandler Medical Center — Gilbert, Arizona, United States
• University of California Irvine Department of Neurology — Orange, California, United States
• University of California San Diego Division of Neurological Surgery — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.