Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hebei Medical University
Sponsor:
Information provided by (Responsible Party):
Quanhai Li, Hebei Medical University
ClinicalTrials.gov Identifier:
NCT01962233
First received: September 11, 2013
Last updated: October 10, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Hypoxic Ischemic Encephalopathy
Biological: mesenchymal stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

Further study details as provided by Hebei Medical University:

Primary Outcome Measures:
  • National Institutes of Health Stroke Scale (NIHSS) scores. [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The Barthel Index [ Time Frame: before treatment and post cell transplantation:15,90,180 days ] [ Designated as safety issue: No ]
    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.

  • The Mini-Mental State Examination (MMSE) [ Time Frame: before treatment and post cell transplantation:15,90,180 days ] [ Designated as safety issue: No ]
    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.

  • The Montreal Cognitive Assessment(MoCA) [ Time Frame: before treatment and post cell transplantation:15,90,180 days ] [ Designated as safety issue: No ]
    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.

  • Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: before treatment and post cell transplantation:15,90,180 days. ] [ Designated as safety issue: No ]
    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.

  • adverse reaction [ Time Frame: post cell transplantation:15,90,180 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 10
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mesenchymal stem cells
Umbilical Cord Derived Mesenchymal Stem Cells at a dose of 100-800 million by intravenous infusion
Biological: 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


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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962233

Contacts
Contact: Ping Gu, Doctor 86-311-85917297 gpwh2000@126.com

Locations
China, Hebei
the First Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050031
Contact: Ping Gu, Doctor    86-311-85917297    gpwh2000@126.com   
Sponsors and Collaborators
Hebei Medical University
Investigators
Study Chair: Baoyong Yan, Doctor Hebei Medical University First Hospital
Study Director: Ping Gu, Doctor Hebei Medical University First Hospital
Principal Investigator: Yanyong Wang, Doctor Hebei Medical University First Hospital
Principal Investigator: Lina Zhang, Master Hebei Medical University First Hospital
Principal Investigator: Jun Zhang, Master Hebei Medical University First Hospital
  More Information

No publications provided

Responsible Party: Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HeibeiMU, Hebei Medical University
ClinicalTrials.gov Identifier: NCT01962233     History of Changes
Other Study ID Numbers: 12276102D-Neurologic Disorder
Study First Received: September 11, 2013
Last Updated: October 10, 2013
Health Authority: China: Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypoxia-Ischemia, Brain
Hypoxia, Brain
Brain Ischemia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on July 22, 2014