Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND) (EXPAND)
Primary Purpose
Acute Ischemic Stroke, Mesenchymal Stem Cells, Stroke, Acute
Status
Temporarily not available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Allogeneic human mesenchymal stem cells (Allo-hMSCs)
Sponsored by
About this trial
This is an expanded access trial for Acute Ischemic Stroke focused on measuring Allogeneic Mesencyhmal Stem cells, Acute Ischemic Stroke, Cell Therapy, Regenerative Therapy, Intravenous
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 < 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.
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
- 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
Sites / Locations
- University of Miami Health Systems
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05522569
First Posted
August 27, 2022
Last Updated
September 21, 2023
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT05522569
Brief Title
Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)
Acronym
EXPAND
Official Title
Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (Allo-hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Temporarily not available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Allogeneic human mesenchymal stem cells (Allo-hMSCs)
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
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 < 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.
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dileep Yavagal, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)
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