Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country20 target enrollmentAugust 2009

ConditionsSystemic Sclerosis Mesenchymal Stem Cells

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Systemic Sclerosis
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment: 20
Locations: 1
Primary Endpoint: mRSS score,HRQOL score, SF-36 score for SSc patients
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant to multiple standard treatments. The underlying hypothesis is that the SSc condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

Detailed Description

* To test a new approach using allogeneic derived mesenchymal stem cell based therapy (MSCT) to treat refractory SSc * To determine the disease-free survival in SSc patients treated with MSCT * To assess adverse events of allogeneic MSC transplantation * To assess the association of remission for organ function, clinical score and SSc serology levels at baseline with disease-free survival

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 2011

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility Criteria

Inclusion Criteria

•All patients fulfilled the American College of Rheumatology (former American Rheumatism Association - ARA) for SSc
•Rapidly progressive disease \<2 years duration with a modified Rodnan skin score(mRSS) above 20, plus ESR \>25 mm/first h and/or Hb \<11 g/dL, not explained by other causes than active SSc
•lung involvement: with a vital capacity (VC) or DLCO below 70% predicted, or a mean pulmonary artery pressure (PAP) above 40 mmHg (measured by echocardiography)
•digestive tract involvement: with serum albumin ,25 g/L or weight loss exceeding 10% body weight in the preceding year
•kidney involvement: with 24-h urinary protein above 0.5 g or serum creatinine above 120 mmol/L

Exclusion Criteria

•Uncontrolled arrhythmia, echocardiographic left ventricular ejection fraction (LVEF) \<50% or mean PAP \>50 mmHg, DLCO\<45% of predicted
•Creatinine clearance \<20 ml/min
•Platelets\<80 000/mm3, haemorrhagic cystitis
•(4) HIV or HTLV1 seropositivity, malignancy, pregnancy, a cardiac or vascular prosthesis, and no vascular access

Outcomes

Primary Outcomes

mRSS score,HRQOL score, SF-36 score for SSc patients

Time Frame: monthly

Secondary Outcomes

Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria(every three month)
SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4(every three month)
Change of peripheral blood B and T cells(every three month)