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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
University of Miami
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • University of Miami Health Systems

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 27, 2022
Last Updated
September 21, 2023
Sponsor
University of Miami
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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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