This study is a first-in-human assessment of safety of using umbilical cord mesenchymal stem cells (UCMSCs) in patients with Acute Ischemic Stroke via a combination of intra arterial (IA) and intravenous (IV) stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IA and IV had never been conducted in humans, there may be unknown risks to humans not predicted from the preclinical studies. However, the risk to patients in this trial will be minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and concentration of stem cells, standardized techniques of stem cell infusion, and intensive patient monitoring during and after stem cell infusion.
Each year about 700,000 people experience a new or recurrent stroke in the United States.Stroke is a leading cause of death, along with cancer and coronary heart disease, and the most common cause of physical disability in adults. Moreover, stroke causes a greater loss of healthy life years, as measured in disability adjusted life years, than other diseases. This product is a new cell therapy product for treating Stroke and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. For animal studies, UMSC01 has been demonstrated its effectiveness for acute myocardial infarction (AMI) and stroke. The UMSC01 has been demonstrated its effective effect in the animal models of stroke in the current studies. The acute stroke rats receiving intracerebral UMSC01 transplantation showed significantly improved neurological function compared to vehicle-treated control rats.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
There will be one dose of IV administration in patients with acute ischemic stroke, or one dose of IV administration followed by low or high doses of IA infusion for acute ischemic stroke with or without bridging therapy (i.e. Intravenous rt-PA thrombolysis or intraarterial thrombectomy) with 12 months of follow up after the first treatment.
China Medical University Hospital
Taichung, Non-US, Taiwan
SAE incidences over the study period
Incidence of SAEs will be presented by coding system. The coding system used will be the MedDRA
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
SUSAR incidences over the study period
Incidence of SUSARs will be presented by coding system. The coding system used will be the MedDRA.
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
TEAE incidences over the study period
Incidence of TEAEs will be presented by coding system. The coding system used will be the MedDRA
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Changes of Glasgow Coma Scale (GCS; Score range: Max.15, Min. 3) from Baseline Visit (Visit 1) to subsequent scheduled visits
Net change of Glasgow Coma Scale (Score Range: 3\~15; the higher score the better outcome) from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Changes in National Institute of Health Stroke Scale (NIHSS; Score Range: 0~42; the higher score the worsen outcome) from Baseline Visit (Visit 1) to subsequent scheduled visits
Net change of NIHSS (Score Range: 0\~42; the higher score the worsen outcome) from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Changes in mRS from Baseline Visit (Visit 1) to subsequent scheduled visits.
The transition (improved, stable, and worsened) from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Changes in FMT from Baseline Visit (Visit 1) to subsequent schedules visits
Net change of FMT from baseline visit to subsequent visits will be summarized by descriptive statistics.
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Changes in BI from Baseline Visit (Visit 1) to subsequent schedules visits
Net change of BI from baseline visit to subsequent visits will be summarized by descriptive statistics
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Change and ratios of MRI image from baseline to subsequent scheduled visits
Net change of infarcted area in the brain will be summarized by descriptive statistics.
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Change and ratios of SPECT perfusion image from baseline to subsequent scheduled visits
Net change of mean transit time (MTT) presented in second and the ratio of MTT between the affected and unaffected hemispheres will be summarized by descriptive statistics
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Change and ratios of SPECT perfusion image from baseline to subsequent scheduled visits
Net change of cerebral blood flow (CBF)(presented in ml/100g/min) and the ratio of CBF between the affected and the unaffected hemisphere will be summarized by descriptive statistics.
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Change and ratios of SPECT perfusion image from baseline to subsequent scheduled visits
Net change of cerebral blood volume (CBV)(present in mL/100g) and the ratio of CBV between the affected and the unaffected hemisphere will be summarized by descriptive statistics.
Time frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.