Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (Allo-hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)

University of Miami2 sites in 1 countryAugust 31, 2022

ConditionsAcute Ischemic Stroke Mesenchymal Stem Cells Stroke, Acute Stroke/Brain Attack Stroke, Ischemic

DrugsAllogeneic human mesenchymal stem cells (Allo-hMSCs)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: University of Miami
Locations: 2
Status: No Longer Available
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to use an intravenous infusion of allogeneic human mesenchymal stem cells (Allo-hMSCs) to treat an acute ischemic stroke condition.

Registry

clinicaltrials.gov

Start Date

August 31, 2022

End Date

TBD

Last Updated

19 days ago

Study Type

Expanded Access

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Dileep Raghvendra Yavagal

Professor of Clinical Medicine

University of Miami

Eligibility Criteria

Inclusion Criteria

•Acute ischemic stroke , had a recent (within the past 9 days), acute, cortical, hemispheric, ischemic stroke in the middle cerebral artery (MCA) distribution without a midline shift as detected by magnetic resonance imaging (MRI) as a diffusion-weighted image (DWI) abnormality
•Qualifying Stroke Event must be confirmed by CT or MRI.
•Age 18 to 80 years If \>80 then the pre-stroke modified Rankin Score (mRS) needs to be \<
•Has a National Institutes of Health Stroke Scale (NIHSS) score of 6 -15 (Right hemisphere), and 6-18 (left hemisphere) at the time of enrollment
•Known onset time of acute symptoms
•Subjects must have a platelet count \>100,000/ Microliter(uL), hemoglobin \>8gm/dl, and white blood cell count (WBC) \>2,500/uL
•Mesenchymal stem cells (MSC) infusion procedure must be performed within 9 days after stroke symptom onset
•Is able to provide consent to participate or consent is obtained from the subject's legally authorized representative
•Subjects who received tissue plasminogen activator (tPA) or underwent mechanical reperfusion may be included in the expanded access experimental treatment
•Patients must be hemodynamically stable post-stroke.

Exclusion Criteria

•Permanent disability corresponding to a Modified Rankin Score of \>1 prior to the Qualifying Stroke Event.
•Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in a modified Rankin Scale \>1 before stroke or has a pre-existing cognitive deficit.
•Ischemic stroke in the last 3 months, any vascular territory. Has clinically significant and/or symptomatic hemorrhage associated with stroke
•Myocardial Infarction (MI), primary hemorrhagic or traumatic lesion of the brain within the last 3 months or identified on magnetic resonance imaging (MRI). Small hemorrhagic transformation of the acute infarct is allowed.
•Seizure disorder
•Developmental delay
•Chronic kidney disease is defined as baseline serum creatinine \>1.4
•Hepatic disease or altered liver function as defined by serum glutamate pyruvate transaminase (SGPT) \>150 U/L and or T. Bilirubin \>1.6 mg/dL at admission
•Pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD) with oxygen requirement at rest or with ambulation, moderate to severe asthma)
•Mechanical heart valve