UnknownPhase 1/2

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

China20 participantsStarted 2009-06

Plain-language 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 multiple standard treatments. The underlying hypothesis is that the pSS condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

Who can participate

Age range

15 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sjögren's syndrome disease activity index

Timeframe: Monthly

Trial details

NCT IDNCT00953485

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12

Contact for this trial

Lingyun Sun, MD

+86-25-83105219 lingyunsun2001@yahoo.com.cn

View on ClinicalTrials.gov More Sjogren's Syndrome trials