A Phase I, Open Label Study to Evaluate the Safety and to Explore the Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Acute Ischemic Stroke
Overview
- Phase
- Phase 1
- Intervention
- UMSC01
- Conditions
- Acute Stroke
- Sponsor
- Ever Supreme Bio Technology Co., Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- TEAE incidences over the study period
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women who are aged ≥ 20, \<50 years old on the date of consent.
- •Pregnant women who are willing to and has given her signed written informed consent.
- •Pregnant women whose gestation age ≥ 34 weeks and have intact placenta.
- •Pregnant women who have not had any complication of pregnancy.
- •Pregnant women who are willing to provide a personal and family medical history (as much available) of herself and the biologic father (as much available), prior to or following collection of the umbilical cord.
Exclusion Criteria
- •Pregnant women who have clinically severe and/or life threatening disease(s) such as uncontrolled diabetes mellitus (fasting sugar level \> 250 mg/dL) and malignant tumor.
- •Pregnant women who have been tested positive for the following tests within 7 days before or after umbilical cord acquirement:
- •Human immunodeficiency virus-1 (HIV-I): anti- HIV-I and nucleic acid test (NAT)
- •Hepatitis B virus (HBV): Hepatitis B surface antigen (HBsAg), anti- Hepatitis B core (HBc) and NAT
- •Hepatitis C virus (HCV): anti-HCV and NAT
- •Cytomegalovirus (CMV)
- •Treponema pallidum
- •Chlamydia trachomatis
- •Neisseria gonorrhea
- •Human T cell leukemia virus-I/II (HTLV-I/II)
Arms & Interventions
UMSC01
UMSC01 cells mixed with normal saline will be administered to patients after the onset of stroke.
Intervention: UMSC01
Outcomes
Primary Outcomes
TEAE incidences over the study period
Time Frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Incidence of TEAEs will be presented by coding system. The coding system used will be the MedDRA
SUSAR incidences over the study period
Time Frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Incidence of SUSARs will be presented by coding system. The coding system used will be the MedDRA.
SAE incidences over the study period
Time Frame: From "baseline visit, prior to the investigational product administration" to "24 weeks"
Incidence of SAEs will be presented by coding system. The coding system used will be the MedDRA
Secondary Outcomes
- Changes in mRS from Baseline Visit (Visit 1) to subsequent scheduled visits.(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(From "baseline visit, prior to the investigational product administration" to "24 weeks")
- Changes in BI from Baseline Visit (Visit 1) to subsequent schedules visits(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(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(From "baseline visit, prior to the investigational product administration" to "24 weeks")
- Changes in FMT from Baseline Visit (Visit 1) to subsequent schedules visits(From "baseline visit, prior to the investigational product administration" to "24 weeks")
- Change and ratios of MRI image from baseline to subsequent scheduled visits(From "baseline visit, prior to the investigational product administration" to "24 weeks")