The Effects of Human Umbilical Cord Mesenchymal Stem Cell Therapy on Neurological Function for Cerebral Infarction Patients in Convalescent Period.
Overview
- Phase
- Phase 1
- Status
- Suspended
- Sponsor
- Sclnow Biotechnology Co., Ltd.
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Motor function analysis
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Experimental group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells
Intervention: Allogeneic umbilical cord mesenchymal stem cell (Biological)
Experimental group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells
Intervention: Aspirin Enteric-coated Tablets & Atorvastatin Calcium (Drug)
Control group
Basic medication：Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo：saline
Intervention: Aspirin Enteric-coated Tablets & Atorvastatin Calcium (Drug)
Outcomes
Primary Outcomes
Motor function analysis
Time Frame: 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 Outcomes
- Limb motor function analysis(6 months)
- Barthel Index analysis(6 months)
- Neurological deficits analysis(6 months)