Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

Nanjing University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Systemic Sclerosis

Mesenchymal Stem Cells

Treatments

Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC)

Study type

Interventional

Funder types

Other

Identifiers

NCT00962923

NJGLYY003

Details and patient eligibility

About

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.

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No 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