Cerebral Infarction
Conditions
Keywords
cerebral Infarction, umbilical cord mesenchymal stem cells
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.
Interventions
Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
DRUGAspirin Enteric-coated Tablets & Atorvastatin Calcium
Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.
Sponsors
Sclnow Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor function analysis | 6 months | Based on Activity of Daily Living Scale (ADL) to analysis efficacy of cell treatment.The score of patient with upper limb \>60, and total score \>90 is considered good recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological deficits analysis | 6 months | According to Chinese scale of clinical neurologic deficit to analysis, the result as follow: * Excellent: after treatment, patient with consciousness, and clinical symptoms improved; * Effective: vital signs and main symptoms in remission; * Inefficient: no obvious improvement or condition worsened. |
| Limb motor function analysis | 6 months | Using fugl-meyer assessment evaluate motor function. Mild movement disorder: 96 - 99; Moderate movement disorder: 85 - 95; Obvious movement disorder: 50 - 84; Serious movement disorder: \< 50 |
| Barthel Index analysis | 6 months | Obvious effective: Barthel Index score between 96 - 99, patient with self care ability. Effective:Barthel Index score between 70 - 89, patient with condition improved. Invalid: The effect do not meet above standards. |
Countries
China
Contacts
STUDY_DIRECTORWulan
Inner Mongolia International Mongolian Hospital
STUDY_CHAIRLei Guo, Dr
China-Japan Union Hospital, Jilin University
Outcome results
None listed