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Trial record 2 of 27 for:    stem cells AND cerebral palsy

Outcomes of Stem Cells for Cerebral Palsy Related to Neonatal Jaundice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier:
NCT03123562
First received: April 17, 2017
Last updated: NA
Last verified: April 2017
History: No changes posted
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal jaundice

Condition Intervention Phase
Cerebral Palsy Combination Product: Stem cell transplantation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Official Title: Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy Related to Neonatal Jaundice: An Open-label Uncontrolled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Vinmec Research Institute of Stem Cell and Gene Technology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change in Muscle tone [ Time Frame: Time Frame: Baseline and 6 months after transplantation ]
    Muscle tone are assessed by Modified Ashworth Scale

  • 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


Enrollment: 40
Actual Study Start Date: April 1, 2014
Study Completion Date: October 31, 2016
Primary Completion Date: September 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy related to neonatal Jaundice at Vinmec International Hospital, Hanoi, Vietnam
  Eligibility

Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cerebral palsy of any types caused by Neonatal Jaundice

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03123562

Locations
Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology
Investigators
Principal Investigator: Liem T Nguyen, MD., PhD Vinmec Research Institute of Stem Cell and Gene Technology
  More Information

Publications:
Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT03123562     History of Changes
Other Study ID Numbers: VinmecRISCGT68
Study First Received: April 17, 2017
Last Updated: April 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
Cerebral palsy
Stem cell
Jaundice

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Pathologic Processes
Jaundice
Jaundice, Neonatal
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Hyperbilirubinemia
Skin Manifestations
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 21, 2017