Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke

NCT04097652 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: UMC119-06-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical study with UMC119-06 is designed to investigate the safety in patients with acute ischemic stroke ("AIS"). This will be a dose escalation, open-label, single-center study in adult with acute ischemic stroke. UMC119-06 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for treatment of acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• The incidence and frequency of adverse events related to administration of UMC119-06.

  * Incidence of Treatment-Emergent Adverse Events (TEAEs). * Incidence of withdrawals due to AEs.

  3 months from the day of administration

Secondary Outcomes (4)

• Changes in Modified Rankin Score (mRS)

  15 months from the day of administration

• Changes in National Institute of Health Stroke Scale (NIHSS)

  15 months from the day of administration

• Changes in Barthel Index (BI)

  15 months from the day of administration

• Changes in Brain MRI

  15 months from the day of administration

Study Arms (1)

UMC119-06

EXPERIMENTAL

Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.

Biological: UMC119-06

Interventions

UMC119-06 BIOLOGICAL

Cohort 1: Low does of UMC119-06；Cohort 2: Medium does of UMC119- 06；Cohort 3: High does of UMC119-06

UMC119-06

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of age between ≥ 20 through ≤ 80 years.
• Subjects who had an onset of ischemic stroke within 48 to 168 hours before start of treatment.
• Subjects with occurrence of an ischemic stroke with clear motor or speech deficit documented by National Institutes of Health Stroke Scale (NIHSS) score of 5 to 20 (at the baseline assessment) that did not change by ≥4 points from the screening to the baseline assessment.
• Subjects who had an onset of ischemic stroke with large-artery atherosclerosis or cardioembolism.
• Subjects with confirmation of hemispheric cortical infarct with brain magnetic resonance imaging (MRI) including diffusion-weighted imaging demonstrating an acute lesion measuring \<100 mL.
• Subjects modified Rankin score of 0 or 1, reported by subject or family, prior to the onset of symptoms of the current stroke.
• Subjects with body weight of 50 to 90 kgs.
• Subject or legal guardian is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
• Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, UNLESS they meet the following criteria:
• (1) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels \> 40mIU/mL, OR; (2) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy

You may not qualify if:

• Subjects with occurrence of a hemorrhagic transformation of ischemic stroke as evidenced by computerized tomography.
• Subjects with a lacunar a lesion of ≤ 1.5 cm of longest diameter or a brainstem infarct on MRI as the etiology of current stroke symptoms.
• Subjects with reduced level of consciousness (score of 3 for item 1a of NIHSS).
• Subjects who experienced seizures since the onset of ischemic stroke.
• Subjects with significant head trauma (GCS=3\~8) or prior stroke within previous 3 months (except transient ischemic attack (TIA)).
• Subjects with uncontrolled hypertension despite antihypertensive treatments (persistent systolic blood pressure \>180 mm Hg or diastolic \>110 mm Hg).
• Subjects with blood glucose concentration \<50 mg/dL or \>400 mg/dL.
• Subjects with uncorrected coagulopathy including, but not limited to:
• International normalized ratio (INR) \>1.4; or
• Activated partial thromboplastin time (aPTT) \< 28sec or \> 50sec ; or
• Platelet (PLT) count \<100,000/ mm3 or \> 700,000/ mm3.
• Subjects with history of any type of malignancy.
• Subjects with major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within previous 30 days.
• Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
• Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:

Sponsors & Collaborators

• Meridigen Biotech Co., Ltd.: lead

Study Sites (1)

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.

New Taipei City, 23561, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Claire Liao, MS

CONTACT

+886-2-8978-7777; claire.liao@meridigen.com

Joseph Chen, MS

CONTACT

+886-2-8978-7777; joseph.chen@meridigen.com

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: September 17, 2019
• First Posted: September 20, 2019
• Study Start: December 5, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: December 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)