Clinical trial NCT01962233: Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy
Official title: Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypoxic Ischemic Encephalopathy
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) scores.
timeFrame: 180 days
Secondary outcomes:
measure: The Barthel Index
timeFrame: before treatment and post cell transplantation:15,90,180 days
measure: The Mini-Mental State Examination (MMSE)
timeFrame: before treatment and post cell transplantation:15,90,180 days
measure: The Montreal Cognitive Assessment(MoCA)
timeFrame: before treatment and post cell transplantation:15,90,180 days
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: before treatment and post cell transplantation:15,90,180 days.
measure: adverse reaction
timeFrame: post cell transplantation:15,90,180 days
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Baoyong Yan, Doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Ping Gu, Doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Yanyong Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Lina Zhang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Jun Zhang, Master
role: PRINCIPAL_INVESTIGATOR
References: