Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01590628
Eligibility Criteria:
Inclusion Criteria:
* Must be 2 - 45 years of age and at least 10 kg
* Must have clinically severe SCD (SS, SC or SBeta0 Thal) or thalassemia major and be eligible for myeloablative SCT
* Must have two partially HLA-matched CBUs for part 1; and one partially HLA-matched CBU for part 2
* Back-up autologous stem cells harvested from bone marrow
* Adequate Karnofsky Performance score or Lansky Play-Performance scale
* Sufficient physiological reserves
* Signed written informed consent
Exclusion Criteria:
* HLA-matched related donor able to donate
* Severe alloimmunization with inability to guarantee a supply of adequate PRBC donors
* Prior allogeneic hematopoietic SCT within the last 12 months or reduced-intensity transplant within the past 6 months
* Human immunodeficiency virus (HIV) infection
* Active or uncontrolled infection
* Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
45 Years
Study:
NCT01590628
Study Brief:
Protocol Section:
NCT01590628