2 United States sites
18 to 65 Years
18 Years - 65 Years
Patients must have confirmed and measurable Sickle Cell Disease, defined by SS or Sβ thalassemia confirmed by hemoglobin fractionation.
≥ 18 to 65 years of age
Patient must have a ECOG performance status ≤2 or Karnofsky score > 70%
Patients must have acceptable organ and marrow function as defined below:
WBC ≥ 3,000/μL
ANC ≥ 1,500/μL
Hemoglobin ≥ 6 gm/dL
Calculated creatinine clearance ≥ 60ml/min * *Using the Cockcroft-gault equation [140 – Age(yrs)] [Weight(kg)] x 0.85 if Female 72 [Serum Creatinine (mg/dL]
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Each patient must be willing to participate as a research subject and must sign an informed consent form.
Patients who are:
Receiving or received treatment with an investigational agent within 4 weeks prior to entering the study OR
have not recovered from adverse events due to agents administered more than 4 weeks earlier as determined by the treating physician.
Patients with ALT(SGPT) > 2.5 X upper limit of normal
Patients with a creatinine clearance of < 60 ml/min Patients who have uncontrolled illness including, but not limited to: Ongoing or active infection Emergency room admission or hospitalization in the past 14 days Major surgery in the past 30 days Medical/psychiatric illness/social situations that would limit compliance with study requirements as determined by the treating physician. Female patients who are pregnant or breast-feeding Patients with active hepatitis B, hepatitis C, or HIV infection Patients with poor cardiac function as defined by an ejection fraction < 40% are excluded due to potential poor tolerance of the fluid shifts with leukapheresis (only for patients enrolled on second phase of protocol for Leukapheresis).