Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy

• ClinicalTrials.gov Identifier: NCT01962233
• Recruitment Status: Unknown
• First Posted: October 14, 2013
• Last Update Posted: October 14, 2013
• Sponsor: Hebei Medical University
• Information provided by (Responsible Party): Quanhai Li, Hebei Medical University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hypoxic Ischemic Encephalopathy	Biological: mesenchymal stem cells	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: September 2013
• Estimated Primary Completion Date: December 2013
• Estimated Study Completion Date: December 2014

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. The Barthel Index [ Time Frame: before treatment and post cell transplantation:15,90,180 days ]
   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.
2. The Mini-Mental State Examination (MMSE) [ Time Frame: before treatment and post cell transplantation:15,90,180 days ]
   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.
3. The Montreal Cognitive Assessment(MoCA) [ Time Frame: before treatment and post cell transplantation:15,90,180 days ]
   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.
4. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: before treatment and post cell transplantation:15,90,180 days. ]
   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.
5. adverse reaction [ Time Frame: post cell transplantation:15,90,180 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

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; The First Hospital of Hebei Medical University
• Study Director: Ping Gu, Doctor; The First Hospital of Hebei Medical University
• Principal Investigator: Yanyong Wang, Doctor; The First Hospital of Hebei Medical University
• Principal Investigator: Lina Zhang, Master; The First Hospital of Hebei Medical University
• Principal Investigator: Jun Zhang, Master; The First Hospital of Hebei Medical University

More Information

• 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
• First Posted: October 14, 2013
• Last Update Posted: October 14, 2013
• Last Verified: September 2013

Additional relevant MeSH terms:

Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hypoxia, Brain