Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.

NCT ID: NCT03176498

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief Summary

This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

Detailed Description

40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.

Conditions

Cerebral Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Basic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells

Group Type: EXPERIMENTAL

Allogeneic umbilical cord mesenchymal stem cell

Intervention Type: BIOLOGICAL

Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)

Aspirin Enteric-coated Tablets & Atorvastatin Calcium

Intervention Type: DRUG

Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

Control group

Basic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Placebo：saline

Group Type: PLACEBO_COMPARATOR

Aspirin Enteric-coated Tablets & Atorvastatin Calcium

Intervention Type: DRUG

Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

Interventions

Allogeneic umbilical cord mesenchymal stem cell

Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)

Intervention Type: BIOLOGICAL

Aspirin Enteric-coated Tablets & Atorvastatin Calcium

Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• proved cerebral infarction by CT or MRI.
• no cerebrovascular disease before
• signed informed consent form

Exclusion Criteria

• serious body and intracranial lesions (tumor, infection, etc.)
• patients repeated cerebral infarction attacks
• multi-foci of cerebral infarction
• history of drug dependence and mental disease
• disturbance of consciousness and non-compliance patients
• subjects who are HIV positive
• pregnant or lactation
• donor: HIV infected, Active hepatitis B/C infected, Syphilis antibody positive
• subjects/ donor: alcoholism, drug addicts or mental disease

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wulan

Role: STUDY_DIRECTOR

Inner Mongolia International Mongolian Hospital

Lei Guo, Dr

Role: STUDY_CHAIR

China-Japan Union Hospital, Jilin University

Locations

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, China

Countries

China

Other Identifiers

SCLnow-IMIMH-01

Identifier Type: -

Identifier Source: org_study_id