Discarded Bone Marrow for Hematology Research

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Dec 15, 2020

Keywords

ClinConnect Summary

This clinical trial, titled "Discarded Bone Marrow for Hematology Research," aims to collect and study bone marrow samples from individuals with blood disorders known as hemoglobinopathies, like sickle cell disease and β-thalassemia. By doing this, researchers hope to learn more about how to use advanced techniques, such as gene therapy, to treat these conditions. The goal is to create a valuable resource of samples that can be analyzed in future studies to improve treatments and understand how these bone marrow cells function.

To participate in this trial, patients of any age must be undergoing orthopedic surgery that involves the removal of bone marrow-containing bone. Eligible patients include those diagnosed with certain types of hemoglobinopathies, as long as they are not experiencing severe complications or infections. Participants in the study can expect to provide their discarded bone marrow samples for research, which may lead to new treatments for these blood disorders. It's important to note that pregnant women and individuals with specific health issues, like low blood counts or a history of excessive bleeding, will not be eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of any age receiving orthopedic surgery for clinical management that involve bone marrow containing bone discard.
• * Patients receiving orthopedic surgery for clinical management will be considered for this study if they have the following diagnosis and criteria:
• • Homozygous S/S disease or doubly heterozygous for S and β thalassemia who are two years or older are eligible.
• • HbE-β- thalassemia or homozygous (severe) β-thalassemia. including those who are transfusion dependent (major) or severely anemic but relatively transfusion independent (intermedia). Diagnostic criteria include standard hematological parameters, red cell indices, hemoglobin electrophoresis and quantitative determination of HbF and HbA2.
• Exclusion Criteria:
• • Active, acute manifestations of sickle cell disease including painful crisis, acute chest syndrome, cerebrovascular events or active infection.
• • Pregnant women will not be eligible for study enrollment
• • Inability or unwillingness of the research participant or legal guardian/representative to give written informed consent will preclude enrollment on this research protocol.
• • Platelet count \< 150,000/mm\^3
• • Neutrophil count \< 2000/mm\^3
• • Neutrophil count \< 1000/mm\^3 for patients on hydroxyurea therapy
• • Prothrombin Time \> 17 seconds
• • Partial thromboplastin Time \> 43 seconds
• • History of excessive bleeding in the context of previous procedures including surgery and dental extractions