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

Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Combination product: Stem cell transplantation

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Vinmec Research Institute of Stem Cell and Gene Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stem cell transplantation; Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward	Combination product: Stem cell transplantation; Transplantation of Autologous Bone Marrow Mononuclear Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle tone	Muscle tone are assessed by Modified Ashworth Scale	Time Frame: Baseline and 6 months after transplantation
Number of adverse events	Examples of adverse events to look for: fever, infections, vomit, epilepsy	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Stem cells; Cerebral palsy; Neonatal icterus
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Skin Manifestations; Hyperbilirubinemia; Cerebral Palsy; Paralysis; Jaundice
• Other Study ID Numbers: VinmecRISCGT68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No