Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.

Detailed Description

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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.

Conditions

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Hypoxic Ischemic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesenchymal stem cells

Umbilical Cord Derived Mesenchymal Stem Cells at a dose of 100-800 million by intravenous infusion

Group Type EXPERIMENTAL

mesenchymal stem cells

Intervention Type BIOLOGICAL

Procedure: 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.

Intravenous infusion of umbilical cord derived mesenchymal stem cells

Interventions

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mesenchymal stem cells

Procedure: 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.

Intravenous infusion of umbilical cord derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Quanhai Li

Director of Cell Thearpy Center, the First Hospital of HeibeiMU

Responsibility Role PRINCIPAL_INVESTIGATOR