Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.
- Conditions
- Cerebral Infarction
- Interventions
- Biological: Allogeneic umbilical cord mesenchymal stem cell
- Registration Number
- NCT03176498
- Lead Sponsor
- Sclnow Biotechnology Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 40
- proved cerebral infarction by CT or MRI.
- no cerebrovascular disease before
- signed informed consent form
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Aspirin Enteric-coated Tablets & Atorvastatin Calcium Basic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells Experimental group Allogeneic umbilical cord mesenchymal stem cell Basic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium； Allogeneic umbilical cord mesenchymal stem cells Control group Aspirin Enteric-coated Tablets & Atorvastatin Calcium Basic medication：Aspirin Enteric-coated Tablets \& Atorvastatin Calcium; Placebo：saline
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.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.
Trial Locations
- Locations (1)
Inner Mongolia International Mongolian Hospital
🇨🇳Hohhot, Inner Mongolia, China