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Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Stem cell transplantation
Sponsored by
Vinmec Research Institute of Stem Cell and Gene Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Stem cells, Neonatal icterus

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cerebral palsy of any types caused by neonatal icterus

Exclusion Criteria:

  • 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

Sites / Locations

  • Vinmec Research Institute of Stem Cell and Gene Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell transplantation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Muscle tone
Muscle tone are assessed by Modified Ashworth Scale
Number of adverse events
Examples of adverse events to look for: fever, infections, vomit, epilepsy

Full Information

First Posted
April 17, 2017
Last Updated
December 22, 2017
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03123562
Brief Title
Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus
Official Title
Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus
Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Stem cells, Neonatal icterus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Intervention Type
Combination Product
Intervention Name(s)
Stem cell transplantation
Intervention Description
Transplantation of Autologous Bone Marrow Mononuclear Cells
Primary Outcome Measure Information:
Title
GMFM-88 and GMFM-66 Percentile
Description
Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile
Time Frame
Time Frame: Baseline and 6 months after transplantation
Secondary Outcome Measure Information:
Title
Change in Muscle tone
Description
Muscle tone are assessed by Modified Ashworth Scale
Time Frame
Time Frame: Baseline and 6 months after transplantation
Title
Number of adverse events
Description
Examples of adverse events to look for: fever, infections, vomit, epilepsy
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cerebral palsy of any types caused by neonatal icterus Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, MD., PhD
Organizational Affiliation
Vinmec Research Institute of Stem Cell and Gene Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28403842
Citation
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.
Results Reference
result
PubMed Identifier
905874
Citation
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.
Results Reference
result
PubMed Identifier
31438885
Citation
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.
Results Reference
derived

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Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

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