NCT03005249

Brief Summary

To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 29, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

December 26, 2016

Last Update Submit

August 27, 2018

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • GMFM-88 score

    To evaluate change in gross motor function in children with cerebral palsy.

    changes of month 1, month 3, month 6, month 9 and month 12 after therapy

Secondary Outcomes (2)

  • Fine Motor Function Measure (FMFM) score

    changes of month 1, month 3, month 6, month 9 and month 12 after therapy

  • Modified Ashworth Scale score

    changes of month 1, month 3, month 6, month 9 and month 12 after therapy

Study Arms (2)

neural stem cells therapy group

EXPERIMENTAL

The patients will be assigned to neural stem cells therapy group for cerebral palsy.

Procedure: neural stem cells therapy group

the control group

EXPERIMENTAL

The patients will be assigned to the control group for cerebral palsy.

Other: the control group

Interventions

neural stem cells therapy groupPROCEDURE

The patients will be assigned to neural stem cells therapy group for cerebral palsy.

neural stem cells therapy group
the control groupOTHER

The patients will be assigned to the control group for cerebral palsy.

the control group

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia and premature infants);
  • Clinical manifestation of spastic tetraplegia;
  • With moderate to severe cerebral palsy, The Gross Motor Function; Classification System (GMFCS) levels IV-V;
  • Age 1-5 years, of either sex;
  • Provision of signed informed consent by one of his/her parents or legal guardians prior to commencement of this study;

You may not qualify if:

  • Systemic diseases that possibly influence treatment or patient's compliance;
  • Potentially life-threatening diseases involving various organ systems;
  • Brain deformity;
  • Abnormal behaviors or mood disorder;
  • Allergies from blood products;
  • Suffering from infectious disease;
  • Subjected to craniocerebral operations prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

Related Publications (1)

  • Lv Z, Li Y, Wang Y, Cong F, Li X, Cui W, Han C, Wei Y, Hong X, Liu Y, Ma L, Jiao Y, Zhang C, Li H, Jin M, Wang L, Ni S, Liu J. Safety and efficacy outcomes after intranasal administration of neural stem cells in cerebral palsy: a randomized phase 1/2 controlled trial. Stem Cell Res Ther. 2023 Feb 9;14(1):23. doi: 10.1186/s13287-022-03234-y.

    PMID: 36759901DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

December 26, 2016

First Posted

December 29, 2016

Study Start

December 1, 2016

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

August 29, 2018

Record last verified: 2018-02

Locations

CN(1)