Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia
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|ClinicalTrials.gov Identifier: NCT01360164|
Recruitment Status : Unknown
Verified November 2012 by Shenzhen Beike Bio-Technology Co., Ltd..
Recruitment status was: Recruiting
First Posted : May 25, 2011
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Ataxia||Biological: human umbilical cord mesenchymal stem cells||Phase 1 Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
Experimental: Human umbilical cord mesenchymal stem cells transplantation
Participants will be given umbilical cord mesenchymal stem cells transplantation with a 1 year follow-up.
Biological: human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.
Other Name: Intervention Group
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360164
|Contact: Yun Xufirstname.lastname@example.org|
|Nanjing University Medical College Affiliated Drum Tower Hospital||Recruiting|
|Nanjing, Jiangsu, China|
|Contact: Yun Xu email@example.com|