Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Myocardial Infarction

NCT04056819 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ES-CMSC01-A1101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment emergent adverse event (TEAE) as presented by MedDRA coding system

  TEAE incidences over the study period

  from visit 2 to 12-month follow-up period

• Incidence of Serious adverse event (SAE) as presented by MedDRA coding system

  SAE incidences over the study period

  from visit 2 to 12-month follow-up period

• Incidence of Suspected and unexpected serious adverse reaction (SUSAR) as presented by MedDRA coding system

  SUSAR incidences over the study period

  from visit 2 to 12-month follow-up period

Secondary Outcomes (15)

• New York Heart Association (NYHA) Classification

  12 weeks

• Incidence of major adverse cardiovascular events (MACE)

  from screen visit to 12-month follow-up period

• Serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)

  52 weeks

• Pulmonary function test

  52 weeks

• Echocardiogram

  52 weeks

Other Outcomes (2)

• Cardiac Positron emission tomography (CPET) to demonstrate perfusion-metabolism mismatch

  52 weeks

• Tl-201 single photon emission computed tomography (SPECT) scan to determine myocardial infarction occurrence

  52 weeks

Study Arms (1)

UMSC01

EXPERIMENTAL

UMSC01 cells mixed with normal saline will be administered to patients after the onset of heart attack.

Biological: Allogeneic umbilical cord mesenchymal stem cells

Interventions

Allogeneic umbilical cord mesenchymal stem cells BIOLOGICAL

UMSC01 cells will be one single IC infusion followed by one single IV infusion with 12 months of follow up after treatment.

UMSC01

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• HIV-II
• 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)
• West Nile virus (WNV) NAT
• Pregnant women are with increased risk for Creutzfeldt-Jakob disease (CJD) if you have received a non-synthetic dura mater transplant, human pituitary-derived growth hormone, or have one or more blood relatives diagnosed with CJD.
• Pregnant women had spent three months or more cumulatively in the United Kingdom from the beginning of 1980 through the end of 1996; or had received any transfusion of blood or blood components in the U.K. or France between 1980 and the present; or lived 5 years or more cumulatively in Europe.
• Pregnant women or her sexual partners were born or lived in certain countries in Africa (Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria) after 1977 (risk factor for HIV group O).

Sponsors & Collaborators

• Ever Supreme Bio Technology Co., Ltd.: lead

Study Sites (1)

China Medical University Hospital

Taichung, Non-US, 404, Taiwan

Location

Related Publications (1)

• Hsiao LC, Lin YN, Shyu WC, Ho M, Lu CR, Chang SS, Wang YC, Chen JY, Lu SY, Wu MY, Li KY, Lin YK, Tseng WI, Su MY, Hsu CT, Tsai CK, Chiu LT, Chen CL, Lin CL, Hu KC, Cho DY, Tsai CH, Chang KC, Jeng LB. First-in-human pilot trial of combined intracoronary and intravenous mesenchymal stem cell therapy in acute myocardial infarction. Front Cardiovasc Med. 2022 Aug 9;9:961920. doi: 10.3389/fcvm.2022.961920. eCollection 2022.

  PMID: 36017096 BACKGROUND

Related Links

• First-in-human pilot trial of combined intracoronary and intravenous mesenchymal stem cell therapy in acute myocardial infarction

Study Officials

• Woei Shyu

  Ever Supreme Bio Technology Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 14, 2019
• Study Start: May 27, 2019
• Primary Completion: August 2, 2021
• Study Completion: December 17, 2021
• Last Updated: September 19, 2024

Record last verified: 2022-03

Locations

TW (1)