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Completed

NCT Number: NCT03123562

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stem cell transplantation

Combination Product

Transplantation of Autologous Bone Marrow Mononuclear Cells

Primary outcomes

  1. GMFM-88 and GMFM-66 Percentile

    Time frame: Time Frame: Baseline and 6 months after transplantation

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

Secondary outcomes

  1. Change in Muscle tone

    Time frame: Time Frame: Baseline and 6 months after transplantation

    Muscle tone are assessed by Modified Ashworth Scale

  2. Number of adverse events

    Time frame: Through study completion, an average of 6 months

    Examples of adverse events to look for: fever, infections, vomit, epilepsy

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2017
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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