A Phase I, Open Label Study to Evaluate the Safety and to Explore Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With ST-elevation Acute Myocardial Infarction
Overview
- Phase
- Phase 1
- Intervention
- Allogeneic umbilical cord mesenchymal stem cells
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Ever Supreme Bio Technology Co., Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is a first-in-human assessment of safety of using UCMSC in patients with AMI via a combination of IC and IV stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IC 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
Cardiovascular disease is the leading cause of death in the developed world, with global deaths due to coronary artery disease estimated to increase from 7.3 million in 2008 to 25 million by 2020 WHO, 2011. The leading symptom that initiates the diagnostic and therapeutic cascade in patients with suspected acute coronary syndromes (ACS) is chest pain. Most patients will ultimately develop an ST elevation myocardial infarction (STEMI). The mainstay of treatment in these patients is immediate reperfusion by primary angioplasty or fibrinolytic therapy. Basically, STEMI comprises approximately 25% to 40% of myocardial infarction (MI) presentations. Acute STEMI is a major cause of morbidity, mortality, and disability. This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. For animal studies, UMSC01 has been demonstrated its effectiveness for AMI and stroke. The rats with coronary artery ligation receiving intravenous injection of UMSC01 showed significantly improved cardiac function.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women who are aged ≥ 20, \<50 years old on 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) (Note: If the pre-screened CMV result shows positive 8 weeks prior to umbilical cord acquirement will also be excluded.)
- •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 heart attack.
Intervention: Allogeneic umbilical cord mesenchymal stem cells
Outcomes
Primary Outcomes
Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system
Time Frame: from visit 2 to 12-month follow-up period
SUSAR incidences over the study period
Incidence of Serious adverse event (SAE) as presented by MedDRA coding system
Time Frame: from visit 2 to 12-month follow-up period
SAE incidences over the study period
Incidence of Treatment emergent adverse event (TEAE) as presented by MedDRA coding system
Time Frame: from visit 2 to 12-month follow-up period
TEAE incidences over the study period
Secondary Outcomes
- Incidence of major adverse cardiovascular events (MACE)(from screen visit to 12-month follow-up period)
- Echocardiogram(52 weeks)
- Cardiac MRI (cMRI) for baseline and efficacy evaluation(52 weeks)
- Serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)(52 weeks)
- Pulmonary function test(52 weeks)
- New York Heart Association (NYHA) Classification(12 weeks)