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Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

Primary Purpose

Systemic Sclerosis, Mesenchymal Stem Cells

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Allogeneic Mesenchymal Stem Cells (AlloMSC)

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring Systemic sclerosis, Mesenchymal Stem Cells, Transplantation

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

the Affiliated Drum Tower Hospital of Nanjing University Medical SchoolRecruiting

Outcomes

Primary Outcome Measures

mRSS score,HRQOL score, SF-36 score for SSc patients

Secondary Outcome Measures

Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria

SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4

Change of peripheral blood B and T cells

Full Information

NCT ID

NCT00962923

First Posted

August 19, 2009

Last Updated

August 19, 2009

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1. Study Identification

Unique Protocol Identification Number

NCT00962923

Brief Title

Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

August 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Sclerosis, Mesenchymal Stem Cells

Keywords

Systemic sclerosis, Mesenchymal Stem Cells, Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Allogeneic Mesenchymal Stem Cells (AlloMSC)

Intervention Description

Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10^6 cells/kg body weight).

Primary Outcome Measure Information:

Title

mRSS score,HRQOL score, SF-36 score for SSc patients

Time Frame

monthly

Secondary Outcome Measure Information:

Title

Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria

Time Frame

every three month

Title

SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4

Time Frame

every three month

Title

Change of peripheral blood B and T cells

Time Frame

every three month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lingyun Sun, MD

Phone

+86-25-83105219

lingyunsun2001@yahoo.com.cn

Facility Information:

Facility Name

the Affiliated Drum Tower Hospital of Nanjing University Medical School

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yitao Ding, MD

Phone

+86-25-83106666

Ext

66866

yitaoding@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

19489103

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.

Results Reference

background

PubMed Identifier

19389752

Citation

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.

Results Reference

background

PubMed Identifier

19118507

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.

Results Reference

background

PubMed Identifier

17402368

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. doi: 10.1177/0961203306075793.

Results Reference

background

PubMed Identifier

28724445

Citation

Zhang H, Liang J, Tang X, Wang D, Feng X, Wang F, Hua B, Wang H, Sun L. Sustained benefit from combined plasmapheresis and allogeneic mesenchymal stem cells transplantation therapy in systemic sclerosis. Arthritis Res Ther. 2017 Jul 19;19(1):165. doi: 10.1186/s13075-017-1373-2.

Results Reference

derived

PubMed Identifier

22542159

Citation

Akiyama K, Chen C, Wang D, Xu X, Qu C, Yamaza T, Cai T, Chen W, Sun L, Shi S. Mesenchymal-stem-cell-induced immunoregulation involves FAS-ligand-/FAS-mediated T cell apoptosis. Cell Stem Cell. 2012 May 4;10(5):544-55. doi: 10.1016/j.stem.2012.03.007. Epub 2012 Apr 26.

Results Reference

derived

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Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

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