Clinical trial NCT03186456: The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral Infarction
Official title: Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Cerebral Infarction
Keywords: acute cerebral infarction
umbilical cord mesenchymal stem cells
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).

Detailed description: This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.

Eligibility criteria: Inclusion Criteria:

* Patient within 2 weeks onset of symptoms.
* Symptoms and signs of clinically definite acute cerebral infarction patients.
* CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
* Signed informed consent after understanding all possible benefits and harm.

Exclusion Criteria:

* allergic to basic drug
* with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
* tumor, injury, and parasites caused cerebral embolism
* rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
* subject is processing thrombolytic therapy
* subject is pregnancy and of childbearing potential or breast feeding
* participate in any other clinical trial in last 3 months
* bleeding tendency patient; severe bleeding tendency in last 3 month
* with gastric duodenal ulcer
* participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
* participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs
* participants: alcoholism, drug addicted, or other situations may complicated the results
* under other therapy that possibly influence MSC security or efficacy
* investigator supposes not suitable to participate this clinical trail

Primary outcomes:
measure: Treatment related-adverse events counting
timeFrame: 26 weeks
Secondary outcomes:
measure: Modified Rankin Scale
timeFrame: 26 weeks
measure: Barthel activities of daily living (ADL) Index
timeFrame: 26 weeks
measure: NIH stroke scale (NIHSS)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Inner Mongolia International Mongolian Hospital
state: Inner Mongolia
Study officials:
affiliation: Inner Mongolia International Mongolian Hospital
name: Temuqile
role: STUDY_DIRECTOR
affiliation: China-Japan Union Hospital, Jilin University
name: Lei Guo, Dr.
role: STUDY_CHAIR
References: