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Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962923
First Posted: August 20, 2009
Last Update Posted: August 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  Purpose
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.

Condition Intervention Phase
Systemic Sclerosis Mesenchymal Stem Cells Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • mRSS score,HRQOL score, SF-36 score for SSc patients [ Time Frame: monthly ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)
    Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962923


Contacts
Contact: Lingyun Sun, MD +86-25-83105219 lingyunsun2001@yahoo.com.cn

Locations
China, Jiangsu
the Affiliated Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Yitao Ding, MD    +86-25-83106666 ext 66866    yitaoding@hotmail.com   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT00962923     History of Changes
Other Study ID Numbers: NJGLYY003
First Submitted: August 19, 2009
First Posted: August 20, 2009
Last Update Posted: August 20, 2009
Last Verified: August 2009

Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Systemic sclerosis
Mesenchymal Stem Cells
Transplantation

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases