Clinical Trial: Autologous Bone Marrow Stem Cell Therapy for Autism

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

Official Title: Autologous Bone Marrow Stem Cell Therapy for Autism: An Open Label Uncontrolled Clinical Trial

Brief Summary: The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

Detailed Summary: The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam
Sponsor: Vinmec International Hospital

Current Primary Outcome:

• Change in Total Score of Childhood Autism Rating Scale (CARS) [ Time Frame: 3 months and 6 months after transplantation ]
  CARS
• Number of adverse events [ Time Frame: Through study completion, an average of 6 months ]
  Examples of adverse events to look for: vomiting, increased hyperactivity, fever, bleeding, hematoma, seizures and neurological deficits

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Vinmec International Hospital

Dates:
Date Received: December 7, 2015
Date Started: April 2014
Date Completion:
Last Updated: December 8, 2015
Last Verified: December 2015