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

NCT05522569 | Unknown

• 1 other identifier: 20201338
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Allogeneic Mesencyhmal Stem cells; Acute Ischemic Stroke; Cell Therapy; Regenerative Therapy; Intravenous

Interventions

Allogeneic human mesenchymal stem cells (Allo-hMSCs) DRUG

Participants will be treated with one intravenous (IV) infusion of 200 million allogeneic human mesenchymal stem cells (Allo-hMSCs), lasting from 40-90 minutes following an acute ischemic stroke within 9 days after stroke symptom onset.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening or any history of chemotherapy or radiation affecting the bone marrow. Skin cancers (except for melanoma) are permitted.
• Prior immunosuppression, including chemotherapy administration within last 3 years or current immunosuppression as defined by white blood cell count (WBC) \<3 x 103 cells/ml
• Hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \>5x the upper limit of normal). Patients with Gilberts syndrome are eligible for enrollment if other liver function tests are normal, regardless of bilirubin level.
• Known HIV
• Hemoglobin \<10g/dl

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Health Systems

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dileep Yavagal, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: August 31, 2022
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)