Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Ischemic Stroke

NCT04434768 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ES-CMSC01-B1101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (3)

• SAE incidences over the study period

  Incidence of SAEs will be presented by coding system. The coding system used will be the MedDRA

  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.

  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

  From "baseline visit, prior to the investigational product administration" to "24 weeks"

Secondary Outcomes (9)

• 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 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"

• 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 in FMT from Baseline Visit (Visit 1) to subsequent schedules 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"

Study Arms (1)

UMSC01

EXPERIMENTAL

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

Biological: UMSC01

Interventions

UMSC01 BIOLOGICAL

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.

UMSC01

Eligibility Criteria

• Age: 20 Years - 80 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 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.

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)
• 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 (U.K) 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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chon-Haw Tsai, MD

  Attending Physician of study site

  PRINCIPAL INVESTIGATOR

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: May 5, 2020
• First Posted: June 17, 2020
• Study Start: December 2, 2020
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)