NCT05522569No Longer Available不适用
Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (Allo-hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •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.
排除标准
- •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.
- •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
研究者
Dileep Raghvendra Yavagal
Professor of Clinical Medicine
University of Miami
研究点 (2)
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