Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)
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ClinicalTrials.gov Identifier: NCT00962923 |
Recruitment Status : Unknown
Verified August 2009 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was: Recruiting
First Posted : August 20, 2009
Last Update Posted : August 20, 2009
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Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Tracking Information | |||
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First Submitted Date ICMJE | August 19, 2009 | ||
First Posted Date ICMJE | August 20, 2009 | ||
Last Update Posted Date | August 20, 2009 | ||
Study Start Date ICMJE | August 2009 | ||
Estimated Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
mRSS score,HRQOL score, SF-36 score for SSc patients [ Time Frame: monthly ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc) | ||
Official Title ICMJE | Not Provided | ||
Brief Summary | This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant to multiple standard treatments. The underlying hypothesis is that the SSc condition is caused by an abnormal immune homeostasis that can be restored by MSCT. | ||
Detailed Description |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)
Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).
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Study Arms ICMJE | Not Provided | ||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Unknown status | ||
Estimated Enrollment ICMJE |
20 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date ICMJE | December 2011 | ||
Estimated Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years to 65 Years (Child, Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | China | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00962923 | ||
Other Study ID Numbers ICMJE | NJGLYY003 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
Study Sponsor ICMJE | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
Verification Date | August 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |