Status:
UNKNOWN
Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Systemic Sclerosis
Mesenchymal Stem Cells
Eligibility:
All Genders
15-65 years
Phase:
PHASE1
PHASE2
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 ...
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 ass...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00962923
Start Date
August 1 2009
End Date
December 1 2011
Last Update
August 20 2009
Active Locations (1)
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1
the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008