Clinical Trial: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia

Brief Summary: The Hereditary Ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and often associated with poor coordination of hands, speech, and eye movements. Current treatments for Hereditary Ataxias are mainly pharmacological, rehabilitative, or psychological treatments，while no effective treatment available. Stem Cell therapy is a novel and promising therapeutic strategy for Hereditary Ataxias treatment. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with Hereditary Ataxias.

Detailed Summary: This Study is designed to evaluate the the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation in patients with Hereditary Ataxias.
Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.

Current Primary Outcome:

  • scores of International Cooperative Ataxia Rating Scale （ICARS） scale and Berg Scale [ Time Frame: 1 year after treatment ]
  • the volume of Cerebellum of Brain Magnetic Resonance Imaging （MRI） Scan [ Time Frame: 1 year after treatment ]


Original Primary Outcome:

  • scores of ICARS scale and Berg Scale [ Time Frame: 1 year after treatment ]
  • the volume of Cerebellum of Brain MRI Scan [ Time Frame: 1 year after treatment ]


Current Secondary Outcome:

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year after treatment ]
  • Number of Participants with Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year after treatment ]


Original Secondary Outcome: Same as current

Information By: Shenzhen Beike Bio-Technology Co., Ltd.

Dates:
Date Received: May 23, 2011
Date Started: January 2010
Date Completion: December 2013
Last Updated: November 26, 2012
Last Verified: November 2012