Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

Safety and Efficacy Investigation of Patients With Hypoxic Ischemic Encephalopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01962233
• Other study ID #: 12276102D-Neurologic Disorder
• Status: Recruiting
• Phase: Phase 1
• First received: September 11, 2013
• Last updated: October 10, 2013
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2013
• Source: Hebei Medical University
• Contact: Ping Gu, Doctor
• Phone: 86-311-85917297
• Email: gpwh2000[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Ischemia

Intervention

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

Locations

Country	Name	City	State
China	the First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale (NIHSS) scores.	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).	180 days	No
Secondary	The Barthel Index	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.	before treatment and post cell transplantation:15,90,180 days	No
Secondary	The Mini-Mental State Examination (MMSE)	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.	before treatment and post cell transplantation:15,90,180 days	No
Secondary	The Montreal Cognitive Assessment(MoCA)	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.	before treatment and post cell transplantation:15,90,180 days	No
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)	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.	before treatment and post cell transplantation:15,90,180 days.	No
Secondary	adverse reaction	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.	post cell transplantation:15,90,180 days	Yes