Status:
UNKNOWN
Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Sjogren's Syndrome
Mesenchymal Stem Cells
Eligibility:
All Genders
15-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
* 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 patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00953485
Start Date
June 1 2009
End Date
December 1 2011
Last Update
August 20 2009
Active Locations (1)
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1
the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008