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

Sclnow Biotechnology

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Cerebral Infarction

Treatments: Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Biological: Allogeneic umbilical cord mesenchymal stem cell

Study type: Interventional

Funder types: Industry

Identifiers

NCT03176498

SCLnow-IMIMH-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Experimental group

Experimental group

Description:

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

Treatment:

Biological: Allogeneic umbilical cord mesenchymal stem cell

Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Aspirin Enteric-coated Tablets & Atorvastatin Calcium