NCT01962233

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 14, 2013

Status Verified

September 1, 2013

Enrollment Period

3 months

First QC Date

September 11, 2013

Last Update Submit

October 10, 2013

Conditions

Hypoxic Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • The Barthel Index

    before treatment and post cell transplantation:15,90,180 days

  • The Mini-Mental State Examination (MMSE)

    before treatment and post cell transplantation:15,90,180 days

  • The Montreal Cognitive Assessment(MoCA)

    before treatment and post cell transplantation:15,90,180 days

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    before treatment and post cell transplantation:15,90,180 days.

  • adverse reaction

    post cell transplantation:15,90,180 days

Study Arms (1)

mesenchymal stem cells

EXPERIMENTAL

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

Biological: mesenchymal stem cells

Interventions

mesenchymal stem cellsBIOLOGICAL

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

mesenchymal stem cells

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Baoyong Yan, Doctor

    The First Hospital of Hebei Medical University

    STUDY CHAIR

  • Ping Gu, Doctor

    The First Hospital of Hebei Medical University

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Gu, Doctor

CONTACT

86-311-85917297gpwh2000@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cell Thearpy Center, the First Hospital of HeibeiMU

Study Record Dates

First Submitted

September 11, 2013

First Posted

October 14, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

October 14, 2013

Record last verified: 2013-09

Locations

CN(1)