Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis

Exclusion Criteria

• •1. Poor performance status (ECOG \> or =2) at the time of entry, unless due to disease.
• •2. Significant end organ damage such as:
• •1. LVEF \<40% or deterioration of LVEF during exercise test on MUGA or echocardiogram
• •2. Untreated life-threatening arrhythmia
• •3. Active ischemic heart disease or heart failure
• •4. DLCO less than 45% of predicted value, unless due to disease.
• •5. Pulmonary hypertension (estimated systolic pulmonary arterial pressure \>40 mmHg by Doppler echocardiography or 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
• •3. HIV positive
• •4. 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
• •5. 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.
• •6. 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
• •7. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
• •8. Inability to give informed consent
• •9. Age \<18 or \> 55 years old
• •1. Age \> 50 years old or \<18 years old
• •2. HIV positive
• •3. Active ischemic heart disease or heart failure
• •4. Acute or chronic active hepatitis
• •5. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the donor to tolerate stem cell collection
• •6. 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.
• •7. Positive pregnancy test
• •8. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
• •9. Major hematological abnormalities such as platelet count less than 100,000/ul, ANC less than 1000/ul
• •10. If donor is sibling must collect a minimum of 2. 106CD34+ cells/kg to proceed to transplant
• •11. If donor is cord blood unit(s) then a minimum number of nucleated cells available must be more than 2 x 107 /kg. To achieve this number of nucleated cells, two units of HLA matched cord blood may be utilized. (Wagner JE Blood. 2005 Feb 1;105(3):1343-7)