NO_LONGER_AVAILABLENot Applicable

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

United States

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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 \< 1.
✓. 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

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

Trial details

NCT IDNCT05522569

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Acute Ischemic Stroke trials