Ignite Creation Date:
2025-12-18 @ 8:35 AM
Ignite Modification Date:
2025-12-23 @ 6:58 PM
Study NCT ID:
NCT00953485
Status:
None
Last Update Posted:
2009-08-20 00:00:00
First Post:
2009-08-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)
Sponsor:
None
Organization:
Study Overview
Official Title:
Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase Ⅰ/Ⅱ
Status:
None
Status Verified Date:
2009-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* 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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: