Clinical Trial: Outcomes of Stem Cells for Cerebral Palsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.
Sponsor: Vinmec International Hospital

Current Primary Outcome:

• Change in Total Score of Gross Motor Function Measure (GMFM)-88 [ Time Frame: 3 months and 6 months after transplantation ]
  GMFM-88
• Change in Gross Motor Function Measure (GMFM)-66 Percentile [ Time Frame: 3 months and 6 months after transplantation ]
  GMFM-66 percentile

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Muscle tone [ Time Frame: 3 months 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: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy

Original Secondary Outcome: Same as current

Information By: Vinmec International Hospital

Dates:
Date Received: October 9, 2015
Date Started: November 2015
Date Completion:
Last Updated: October 15, 2015
Last Verified: October 2015