Trial | NCT03176498  Report issue

Title

Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.
The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    40
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.
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.
Study Started
Dec 31
2023
Anticipated
Primary Completion
Jun 30
2024
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Apr 13
2023

Biological Allogeneic umbilical cord mesenchymal stem cell

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

Drug Aspirin Enteric-coated Tablets & Atorvastatin Calcium

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

Experimental group Experimental

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

Control group Placebo Comparator

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

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
No Results Posted