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.
Stroke is the second most important cause of mortality and morbidity in the world. Currently, the standard treatment for ischemic stroke is an intravenous tissue plasminogen activator(tPA; alteplase) and/or endovascular thrombectomy. However, the therapeutic time window for these treatments is narrow. Besides, endovascular thrombectomy requires specialized stroke expertise and endovascular skills. Less than 5% of ischemic stroke patients are treated by these therapy and not all patients achieve good outcomes. There is still a lack of therapy for the reduction disability from stroke. In 2018, at least 40 clinical trials intent to treat ischemic stroke using cell therapy. In particular, MSCs have shown great potential in the reduction disability from acute ischemic stroke (AIS). Meridigen is developing UMC119-06, a mesenchymal stem cell derived from human umbilical cord for the treatment of AIS disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Cohort 1: Low does of UMC119-06;Cohort 2: Medium does of UMC119- 06;Cohort 3: High does of UMC119-06
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
New Taipei City, Taiwan
RECRUITINGThe 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.
Time frame: 3 months from the day of administration
Changes in Modified Rankin Score (mRS)
Improvement in clinical function as assessed by change in Modified Rankin Score (mRS)
Time frame: 15 months from the day of administration
Changes in National Institute of Health Stroke Scale (NIHSS)
Improvement in clinical function as assessed by change in National Institute of Health Stroke Scale (NIHSS)
Time frame: 15 months from the day of administration
Changes in Barthel Index (BI)
Improvement in clinical function as assessed by change in Barthel Index (BI)
Time frame: 15 months from the day of administration
Changes in Brain MRI
Improvement in clinical function as assessed by change in Brain MRI
Time frame: 15 months from the day of administration
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