Acute Ischemic StrokeEXPANDNCT05522569
Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)
A study testing Allogeneic human mesenchymal stem cells (Allo-hMSCs) in people with Acute Ischemic Stroke and Mesenchymal Stem Cells, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Mesenchymal Stem Cells, Stroke, Acute
- What is being tested?
- Allogeneic human mesenchymal stem cells (Allo-hMSCs)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- 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)
- Any hemodynamic instability at the time of consent (e.g., requiring continuous fluid resuscitation or ionotropic support).
- 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.
- Pregnancy or positive human chorionic gonadotropin (HCG) or lactating women
- Subjects participating in another interventional clinical trial of an investigational therapy within 30 days of screening
- Unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
- Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)
- Unable to undergo MRI or CT scan
- Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
- 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.
- Exclude Intra Arterial (IA) therapy use or if there is a planned or anticipated hemicraniectomy. Diagnostic angiograms are allowed
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Health Systems
Miami, Florida, 33136
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke, Mesenchymal Stem Cells, Stroke, Acute, Stroke/Brain Attack, Stroke, Ischemic
- Being tested
- Allogeneic human mesenchymal stem cells (Allo-hMSCs)
- Keywords
- Allogeneic Mesencyhmal Stem cells, Acute Ischemic Stroke, Cell Therapy, Regenerative Therapy, Intravenous
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dileep Raghvendra Yavagal, University of Miami
- Investigators
- Dileep Yavagal, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522569
- Sponsor's protocol ID
- 20201338
- Acronym
- EXPAND
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (Allo-hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)
- ClinicalTrials.gov ID
- NCT05522569
- Acronym / sponsor ID
- EXPAND / 20201338
- Conditions
- Acute Ischemic Stroke, Mesenchymal Stem Cells, Stroke, Acute, Stroke/Brain Attack, Stroke, Ischemic
- Keywords
- Allogeneic Mesencyhmal Stem cells, Acute Ischemic Stroke, Cell Therapy, Regenerative Therapy, Intravenous
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of MiamiUniversity, hospital or other
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic human mesenchymal stem cells (Allo-hMSCs)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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dileep Yavagal, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic human mesenchymal stem cells (Allo-hMSCs) in people with Acute Ischemic Stroke and Mesenchymal Stem Cells, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.