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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00953485
• Date of registration: 04/08/2009
• Prospective Registration: No
• Primary sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Public title: Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)
• Scientific title: Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase ?/?
• Date of first enrolment: June 2009
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00953485
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Lingyun Sun, MD

• Name: Lingyun Sun, MD
• Affiliation: the Affiliated Drum Tower Hospital of Nanjing University Medical School

Key inclusion & exclusion 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.



Age minimum: 15 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Mesenchymal Stem Cells

Intervention(s)

Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)

Primary Outcome(s)

Sjögren's syndrome disease activity index [Time Frame: Monthly]

Secondary Outcome(s)

Improvement of salivary gland function (measured as stimulated saliva flow rate) [Time Frame: Monthly]

pSS Serology (ANA, dsDNA, SS-A, SS-B) [Time Frame: Monthly]

Secondary ID(s)

NJGLYY002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors