Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00962923
• Date of registration: 19/08/2009
• Prospective Registration: No
• Primary sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Public title: Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)
• Date of first enrolment: August 2009
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00962923
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Lingyun Sun, MD

• Name: Yitao Ding, MD

Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Mesenchymal Stem Cells

Intervention(s)

Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)

Primary Outcome(s)

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

Secondary Outcome(s)

Change of peripheral blood B and T cells [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]

Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria [Time Frame: every three month]

Secondary ID(s)

NJGLYY003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors