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Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

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ClinicalTrials.gov Identifier: NCT00962923
Recruitment Status : Unknown
Verified August 2009 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : August 20, 2009
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tracking Information
First Submitted Date  ICMJE August 19, 2009
First Posted Date  ICMJE August 20, 2009
Last Update Posted Date August 20, 2009
Study Start Date  ICMJE August 2009
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
mRSS score,HRQOL score, SF-36 score for SSc patients [ Time Frame: monthly ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
  • Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria [ Time Frame: every three month ]
  • SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4 [ Time Frame: every three month ]
  • Change of peripheral blood B and T cells [ Time Frame: every three month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)
Official Title  ICMJE Not Provided
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Systemic Sclerosis
  • Mesenchymal Stem Cells
Intervention  ICMJE Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)
Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 19, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00962923
Other Study ID Numbers  ICMJE NJGLYY003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP