Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypoxic Ischemic Encephalopathy
- Sponsor
- Hebei Medical University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- National Institutes of Health Stroke Scale (NIHSS) scores.
- Last Updated
- 12 years ago
Overview
Brief Summary
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.
Detailed Description
To date,hypoxic ischemic encephalopathy is refractory, including after carbon monoxide poisoning, cardiopulmonary resuscitation,hemorrhagic shock and cerebral infarction etc. We used Mesenchymal Stem Cells via portal vein infusion method to treat hypoxic ischemic encephalopathy. With different durations of follow-up, we cleared therapeutic effect, the quality of life and prognostic implications of the cord blood stem cell infusion on hypoxic ischemic encephalopathy, and evaluated the adverse reactions, through the neurological function score (NIHSS，Barthel Index), cognitive score (MoCA, MMSE),and the international uniform Parkinson Rating Scale score (UPDRS). Here, we seek new means for the treatment of hypoxic ischemic encephalopathy, and provide the basis for clinical for further application of umbilical cord blood derived Mesenchymal stem cells. On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect. The neurological function score (NIHSS score, Barthel Index) was observed in patients with the ability to live independently and prognosis; MoCA, MMSE were used in the evaluation of cognitive function ；UPDRS was used in the evaluation of extrapyramidal tract function.
Investigators
Quanhai Li
Director of Cell Thearpy Center, the First Hospital of HeibeiMU
Hebei Medical University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
National Institutes of Health Stroke Scale (NIHSS) scores.
Time Frame: 180 days
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).
Secondary Outcomes
- The Barthel Index(before treatment and post cell transplantation:15,90,180 days)
- The Mini-Mental State Examination (MMSE)(before treatment and post cell transplantation:15,90,180 days)
- The Montreal Cognitive Assessment(MoCA)(before treatment and post cell transplantation:15,90,180 days)
- Unified Parkinson's Disease Rating Scale (UPDRS)(before treatment and post cell transplantation:15,90,180 days.)
- adverse reaction(post cell transplantation:15,90,180 days)