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Completed

NCT Number: NCT02574923

Outcomes of Stem Cells for Cerebral Palsy

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

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Key information

Conditions

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

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vinmec International Hospital

Hanoi, Vietnam

About this study

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy 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 oxygen deprivation.

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

autologous bone marrow mononuclear cells

Biological

Transplantation of Autologous Bone Marrow Mononuclear Cells

Primary outcomes

  1. Change in Total Score of Gross Motor Function Measure (GMFM)-88

    Time frame: 3 months and 6 months after transplantation

    GMFM-88

  2. Change in Gross Motor Function Measure (GMFM)-66 Percentile

    Time frame: 3 months and 6 months after transplantation

    GMFM-66 percentile

Secondary outcomes

  1. Change in Muscle tone

    Time frame: 3 months 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: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy

  3. Change in Denver Developmental Score

    Time frame: 3 months and 6 months after transplantation

    Denver II

  4. Change in Quality of Life

    Time frame: 3 months and 6 months after transplantation

    Quality of life questionnaire for cerebral palsy (CPQOL)

Sponsors and collaborators

Lead sponsor

Vinmec Healthcare System

Other

Registry information

Official study title

Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 14, 2015
Registry last updated
May 7, 2018

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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