Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

Systemic Sclerosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00962923
• Other study ID #: NJGLYY003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 19, 2009
• Last updated: August 19, 2009
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2009
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Lingyun Sun, MD
• Phone: +86-25-83105219
• Email: lingyunsun2001[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mesenchymal Stem Cells
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Biological:
• Allogeneic Mesenchymal Stem Cells (AlloMSC)
Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).

Locations

Country	Name	City	State
China	the Affiliated Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (4)

Liang J, Zhang H, Hua B, Wang H, Wang J, Han Z, Sun L. Allogeneic mesenchymal stem cells transplantation in treatment of multiple sclerosis. Mult Scler. 2009 May;15(5):644-6. doi: 10.1177/1352458509104590. — View Citation

Sun L, Akiyama K, Zhang H, Yamaza T, Hou Y, Zhao S, Xu T, Le A, Shi S. Mesenchymal stem cell transplantation reverses multiorgan dysfunction in systemic lupus erythematosus mice and humans. Stem Cells. 2009 Jun;27(6):1421-32. doi: 10.1002/stem.68. — View Citation

Sun LY, Zhang HY, Feng XB, Hou YY, Lu LW, Fan LM. Abnormality of bone marrow-derived mesenchymal stem cells in patients with systemic lupus erythematosus. Lupus. 2007;16(2):121-8. — View Citation

Zhou K, Zhang H, Jin O, Feng X, Yao G, Hou Y, Sun L. Transplantation of human bone marrow mesenchymal stem cell ameliorates the autoimmune pathogenesis in MRL/lpr mice. Cell Mol Immunol. 2008 Dec;5(6):417-24. doi: 10.1038/cmi.2008.52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRSS score,HRQOL score, SF-36 score for SSc patients		monthly	Yes
Secondary	Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria		every three month	Yes
Secondary	SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4		every three month	Yes
Secondary	Change of peripheral blood B and T cells		every three month	Yes