Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma

Exclusion Criteria

• •Poor performance status Eastern Cooperative Oncology Group (ECOG 2) at the time of entry.
• •Significant end organ damage such as:
• •1. Left Ventricular Ejection Fraction (LVEF) \< 40% or deterioration of LVEF during exercise test on Multiple Gated Acquisition (MUGA) or echocardiogram.
• •2. Untreated life-threatening arrhythmia.
• •3. Active ischemic heart disease or heart failure.
• •4. End-stage lung disease characterized by total lung capacity (TLC) \<45% of predicted value.
• •5. Pulmonary hypertension (systolic pulmonary arterial pressure \> 40 mmHg or mean pulmonary arterial pressure (PAP) \> 25 mmHG measurement by pulmonary arterial catheter).
• •6. Serum creatinine \> 2.0 mg/dl.
• •7. Liver cirrhosis, transaminases \> 3x of normal limits or bilirubin \> 2.0 unless due to Gilberts disease.
• •8. Pericardial effusion\> 200ml unless successful pericardiocentesis
• •9. Tricuspid annular peak systolic excursion (TAPSE) ≤ 1.9 cm
• •10. MRI of heart showing D sign (intraventricular flattering)
• •Human immunodeficiency virus (HIV) positive.
• •Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment.
• •Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as (but not limited to) head and neck cancer, or stage I or II breast cancer will be considered on an individual basis.
• •Positive pregnancy test, inability or unable to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
• •Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
• •Inability to give informed consent.
• •Major hematological abnormalities such as platelet count \< 100,000/ul or absolute neutrophil count (ANC) \< 1000/ul.
• •Patients with duration of disease \> 5 years.
• •Exclude if \> than 6 prior monthly IV cyclophosphamide treatments.