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Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT00962923
First received: August 19, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria [ Time Frame: every three month ] [ Designated as safety issue: Yes ]
  • SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4 [ Time Frame: every three month ] [ Designated as safety issue: Yes ]
  • Change of peripheral blood B and T cells [ Time Frame: every three month ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: August 19, 2009
Last Updated: August 19, 2009
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013