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

April 6, 2026 updated by: Dileep Raghvendra Yavagal, University of Miami

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. 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
  2. Qualifying Stroke Event must be confirmed by CT or MRI.
  3. Age 18 to 80 years If >80 then the pre-stroke modified Rankin Score (mRS) needs to be < 1.
  4. 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
  5. Known onset time of acute symptoms
  6. Subjects must have a platelet count >100,000/ Microliter(uL), hemoglobin >8gm/dl, and white blood cell count (WBC) >2,500/uL
  7. Mesenchymal stem cells (MSC) infusion procedure must be performed within 9 days after stroke symptom onset
  8. Is able to provide consent to participate or consent is obtained from the subject's legally authorized representative
  9. Subjects who received tissue plasminogen activator (tPA) or underwent mechanical reperfusion may be included in the expanded access experimental treatment
  10. Patients must be hemodynamically stable post-stroke.

Exclusion Criteria:

  1. Permanent disability corresponding to a Modified Rankin Score of >1 prior to the Qualifying Stroke Event.
  2. 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.
  3. Ischemic stroke in the last 3 months, any vascular territory. Has clinically significant and/or symptomatic hemorrhage associated with stroke
  4. 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.
  5. Seizure disorder
  6. Developmental delay
  7. Chronic kidney disease is defined as baseline serum creatinine >1.4
  8. 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
  9. Pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD) with oxygen requirement at rest or with ambulation, moderate to severe asthma)
  10. Mechanical heart valve
  11. 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.
  12. 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
  13. 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.
  14. Known HIV
  15. Hemoglobin <10g/dl
  16. Uncorrected coagulopathy at the time of consent defined as international normalized ratio (INR) >1.4; partial thromboplastin time (PTT) >37 sec, or thrombocytopenia (PLT<100,000)
  17. Any hemodynamic instability at the time of consent (e.g., requiring continuous fluid resuscitation or ionotropic support).
  18. Hypoxemia (SaO2<90%) at the time of consent, respiratory distress or persistent hypoxemia defined as SaO2 <94% for >30 minutes occurring at any time from hospital admission to time of consent. Intubation alone is not an exclusion.
  19. Pregnancy or positive human chorionic gonadotropin (HCG) or lactating women
  20. Subjects participating in another interventional clinical trial of an investigational therapy within 30 days of screening
  21. Unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
  22. Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)
  23. Unable to undergo MRI or CT scan
  24. Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
  25. Exclude infarct lesion size >145cc unless the NIHSS 1a remains < 1 and there is no evidence of infarct expansion or edema formation on any imaging obtained from admission up to the point just prior to infusion.
  26. Exclude Intra Arterial (IA) therapy use or if there is a planned or anticipated hemicraniectomy. Diagnostic angiograms are allowed
  27. CT and/or Multimodal MRI exclusion criteria will be: hemispheric strokes < 1.5 cm maximum diameter (on the MRI as seen on the diffusion-weighted imaging or CT)- in order to exclude mild strokes and lacunar strokes of midline shift >1mm or significant hemorrhagic transformation of the acute infarct

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Dileep Yavagal, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 27, 2022

First Submitted That Met QC Criteria

August 27, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201338

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke, Ischemic

Clinical Trials on Allogeneic human mesenchymal stem cells (Allo-hMSCs)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe