The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral Infarction

Sclnow Biotechnology

Status and phase: Suspended; Phase 1

Conditions: Cerebral Infarction

Treatments: Drug: Aspirin Tablet; Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03186456

SCLnow-IMIMH-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1\*10\^6/kg

Treatment:

Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Drug: Aspirin Tablet

Group 2

Placebo Comparator group

Description:

Aspirin Tablet, 100mg/d; Placebo

Treatment:

Drug: Aspirin Tablet