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Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT00953485
First received: August 4, 2009
Last updated: August 19, 2009
Last verified: August 2009

August 4, 2009
August 19, 2009
June 2009
December 2010   (final data collection date for primary outcome measure)
Sjögren's syndrome disease activity index [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00953485 on ClinicalTrials.gov Archive Site
  • pSS Serology (ANA, dsDNA, SS-A, SS-B) [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Improvement of salivary gland function (measured as stimulated saliva flow rate) [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)
Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase Ⅰ/Ⅱ

This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of primary Sjögren's Syndrome (pSS) who have been resistant to multiple standard treatments. The underlying hypothesis is that the pSS condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

  • To test a new approach using allogeneic derived mesenchymal stem cell based therapy (MSCT) to treat refractory primary Sjögren's Syndrome (pSS)
  • To determine the disease-free survival in pSS patients treated with MSCT in terms of disease activity index, pSS serology and salivary gland function
  • To assess adverse events of allogeneic MSC transplantation
  • To assess the association of disease activity index, pSS serology levels, and saliva flow rate at baseline with disease-free survival
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sjogren's Syndrome
  • Mesenchymal Stem Cells
Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)
Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients fulfilled the international classification criteria (2002) for primary Sjögren's Syndrome, man or woman aged from 15 to 70 years old, Sjögren's Syndrome Disease Activity Index (SSDAI)≥8.
  • Stimulated whole saliva flow rate less than 1~6ml/6min.
  • Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
  • Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial and for 12 months following treatment. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.

Exclusion Criteria:

  • End-stage renal failure.
  • Severe cardiopulmonary compromise, or other system failure.
  • Active, uncontrolled infections.
  • Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
Both
15 Years to 70 Years
No
Contact: Lingyun Sun, MD +86-25-83105219 lingyunsun2001@yahoo.com.cn
China
 
NCT00953485
NJGLYY002
Yes
the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Not Provided
Principal Investigator: Lingyun Sun, MD the Affiliated Drum Tower Hospital of Nanjing University Medical School
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP