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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Sjogren's Syndrome
Mesenchymal Stem Cells
 Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase Ⅰ/Ⅱ

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • Sjögren's syndrome disease activity index [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)
    Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).
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 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
  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953485

Contacts
Contact: Lingyun Sun, MD +86-25-83105219 lingyunsun2001@yahoo.com.cn

Locations
China, Jiangsu
the Affiliated Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
Principal Investigator: Lingyun Sun, MD the Affiliated Drum Tower Hospital of Nanjing University Medical School
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT00953485     History of Changes
Other Study ID Numbers: NJGLYY002
Study First Received: August 4, 2009
Last Updated: August 19, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Sjogren's Syndrome
Mesenchymal Stem Cells
Transplantation

Additional relevant MeSH terms:
Sjogren's Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
 Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013