RECRUITING

Discarded Bone Marrow for Hematology Research

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to establish a mechanism to obtain discarded bone marrow-containing bone samples from hemoglobinopathy, as well as non-hemoglobinopathy individuals. The processing of samples will help to understand how best to manipulate HSPC's from hemoglobinopathy patients with gene therapy and gene technologies in the laboratory environment. It will also allow us to establish a reservoir of samples that can be studied in the future to assess cellular function and fitness for transplant. Secondary objectives * To develop gene transfer and gene editing strategies as potentially curative therapy for hemoglobinopathies (e.g. sickle cell disease (SCD) and β-thalassemia). * To develop a drug treatment strategy which elevates the expression of fetal hemoglobin to a potentially curative level for hemoglobinopathies. * To examine the biology of bone marrow cells isolated from patients with hemoglobinopathies.

Official Title

Discarded Bone Marrow for Hematology Research

Quick Facts

Study Start:2022-07-26
Study Completion:2035-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04671212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients of any age receiving orthopedic surgery for clinical management that involve bone marrow containing bone discard.
  2. * Patients receiving orthopedic surgery for clinical management will be considered for this study if they have the following diagnosis and criteria:
  3. * Homozygous S/S disease or doubly heterozygous for S and β thalassemia who are two years or older are eligible.
  4. * 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.
  1. * Active, acute manifestations of sickle cell disease including painful crisis, acute chest syndrome, cerebrovascular events or active infection.
  2. * Pregnant women will not be eligible for study enrollment
  3. * Inability or unwillingness of the research participant or legal guardian/representative to give written informed consent will preclude enrollment on this research protocol.
  4. * Platelet count \< 150,000/mm\^3
  5. * Neutrophil count \< 2000/mm\^3
  6. * Neutrophil count \< 1000/mm\^3 for patients on hydroxyurea therapy
  7. * Prothrombin Time \> 17 seconds
  8. * Partial thromboplastin Time \> 43 seconds
  9. * History of excessive bleeding in the context of previous procedures including surgery and dental extractions

Contacts and Locations

Study Contact

Shannon McKinney-Freeman, Ph.D.
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

Shannon McKinney-Freeman, Ph.D.
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Shannon McKinney-Freeman, Ph.D., PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-26
Study Completion Date2035-01

Study Record Updates

Study Start Date2022-07-26
Study Completion Date2035-01

Terms related to this study

Keywords Provided by Researchers

  • Bone samples
  • Bone marrow
  • Discarded
  • Hemoglobinopathies
  • Non-hemoglobinopathies

Additional Relevant MeSH Terms

  • Hemoglobinopathies