Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Patients are screened foe enrollment in the study if both clinal signs and laboratory tests meet the diagnosis standards recommended by International Classification of Diseases-10 about hypoxic ischemic encephalopathy. Exclusion Criteria: Exclusion Criteria are any clinically significant diseases in liver,kidney,and heart. additional exclusion criteria are no pregnancy,no immunosuppressive medication, no tumor, no viral diseases or diseases associated with immunodeficiency. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | the First Hospital of Hebei Medical University | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Hebei Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | National Institutes of Health Stroke Scale (NIHSS) scores. | The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). | 180 days | No |
Secondary | The Barthel Index | The Barthel Index measures 10 activities of daily living and mobility. A score of 100 is best (able to live at home with a degree of independence), 0 is worst. | before treatment and post cell transplantation:15,90,180 days | No |
Secondary | The Mini-Mental State Examination (MMSE) | The Mini-Mental State Examination (MMSE) is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. | before treatment and post cell transplantation:15,90,180 days | No |
Secondary | The Montreal Cognitive Assessment(MoCA) | The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment. | before treatment and post cell transplantation:15,90,180 days | No |
Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) | The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability. | before treatment and post cell transplantation:15,90,180 days. | No |
Secondary | adverse reaction | adverse reaction include temperature changes,the change of blood pressure,anaphylaxis,seizure,renal dysfunction,or hepatic injury by monitoring blood routine, urinalysis, ALT,AST,Urea,Crea and electrocardiogram etc. | post cell transplantation:15,90,180 days | Yes |
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