NCT03414697

Brief Summary

To preliminarily evaluate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSCs), and compare the efficacy of UC-MSCs administered through the intravenous, intrathecal, and intranasal routes, in the treatment of cerebral palsy in children.

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

January 22, 2018

Last Update Submit

January 26, 2018

Conditions

Cerebral Palsy

Keywords

umbilical cord-derived mesenchymal stem cellscerebral palsy

Outcome Measures

Primary Outcomes (1)

  • The Gross Motor Function Measure (GMFM)-88 item score

    a 4-point scale that is divided into five categories including lying and rolling, sitting, crawling and kneeling, standing, walking, running, and jumping. A score of 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes \< 10% of the activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of the activity); 3 indicates that the child completes the task (100%). The sum of score of the five categories is used as the evaluation outcome.It is used to evaluate gross motor function.

    12 months after 2 courses of treatment with UC-MSCs.

Secondary Outcomes (4)

  • Fine Motor Function Measure scale (FMFM) score

    1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs.

  • The Modified Ashworth scale (MAS) score

    1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs.

  • Gesell Development Schedule score

    1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs.

  • Incidence of adverse reactions

    1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs.

Study Arms (4)

Control group

OTHER

Routine rehabilitation treatments

Other: Control group

Intravenous UC-MSCs group

EXPERIMENTAL

Injection of UC-MSCs via the peripheral vein.

Procedure: UC-MSCs

Intrathecal UC-MSCs group

EXPERIMENTAL

Injection of UC-MSCs via the intrathecal route.

Procedure: UC-MSCs

Intranasal UC-MSCs group

EXPERIMENTAL

Injection of UC-MSCs via the nasal route.

Procedure: UC-MSCs

Interventions

Control groupOTHER

The control group received routine rehabilitation treatments including acupuncture, massage, Bobath therapy, and Vojat therapy.

Control group
UC-MSCsPROCEDURE

Injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) (at least 1Ă—10\^7), once every 2 weeks, one course of treatment including two injections within 4 weeks, a total of two courses of treatment.

Intranasal UC-MSCs groupIntrathecal UC-MSCs groupIntravenous UC-MSCs group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients diagnosed with hypoxic/ischemic cerebral palsy, primarily including birth asphyxia and premature children
  • Patients with spastic quadriplegia
  • Patients with moderate to severe cerebral palsy, GMFM scores of 2-3
  • Age at 2-18 years
  • Provision of signed informed consent by legal representatives of the child prior to start of the study

You may not qualify if:

  • Those with systemic diseases that likely interfere with the treatment or child's compliance
  • Those complicated by life-threatening diseases of any organ
  • Those with brain deformity
  • Those with uncontrolled epilepsy
  • Those with abnormal behavior or mood disorders
  • Those with allergies especially those who are allergic to blood products
  • Those are infected with infectious diseases
  • Those who had underwent a craniocerebral surgery in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jing Liu, Ph.D

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liu, Ph.D

CONTACT

86041184394568liujing.dlrmc@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 30, 2018

Study Start

April 1, 2018

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

CN(1)