NCT03123562

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

April 17, 2017

Last Update Submit

December 22, 2017

Conditions

Cerebral Palsy

Keywords

Cerebral palsyStem cellsNeonatal icterus

Outcome Measures

Primary Outcomes (1)

  • GMFM-88 and GMFM-66 Percentile

    Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile

    Time Frame: Baseline and 6 months after transplantation

Secondary Outcomes (2)

  • Change in Muscle tone

    Time Frame: Baseline and 6 months after transplantation

  • Number of adverse events

    Through study completion, an average of 6 months

Study Arms (1)

Stem cell transplantation

EXPERIMENTAL

Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Combination Product: Stem cell transplantation

Interventions

Stem cell transplantationCOMBINATION_PRODUCT

Transplantation of Autologous Bone Marrow Mononuclear Cells

Stem cell transplantation

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cerebral palsy of any types caused by neonatal icterus

You may not qualify if:

  • Epilepsy
  • Hydrocephalus with ventricular drain
  • Coagulation disorders
  • Allergy to anesthetic agents
  • Severe health conditions such as cancer, failure of heart, lung, liver or kidney
  • Active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

Location

Related Publications (4)

  • Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.

    PMID: 28403842RESULT

  • Jasovic M, Kamenica S, Draganic M, Vasovic P, Nikolajevic A. [Differential diagnosis between mediastinal tumors and aneurysms of the thoracic aorta]. Srp Arh Celok Lek. 1977 Jan;105(1):39-45. No abstract available. Serbian.

    PMID: 905874RESULT

  • Than UTT, Nguyen LT, Nguyen PH, Nguyen XH, Trinh DP, Hoang DH, Nguyen PAT, Dang VD. Inflammatory mediators drive neuroinflammation in autism spectrum disorder and cerebral palsy. Sci Rep. 2023 Dec 18;13(1):22587. doi: 10.1038/s41598-023-49902-8.

    PMID: 38114596DERIVED

  • Thanh LN, Trung KN, Duy CV, Van DN, Hoang PN, Phuong ANT, Ngo MD, Thi TN, Viet AB. Improvement in gross motor function and muscle tone in children with cerebral palsy related to neonatal icterus: an open-label, uncontrolled clinical trial. BMC Pediatr. 2019 Aug 22;19(1):290. doi: 10.1186/s12887-019-1669-2.

    PMID: 31438885DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Liem T Nguyen, MD., PhD

    Vinmec Research Institute of Stem Cell and Gene Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 21, 2017

Study Start

April 1, 2014

Primary Completion

September 30, 2016

Study Completion

October 31, 2016

Last Updated

December 26, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)