At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bilateral Orthotopic Lung Transplant in Tandem With CD3+ and CD19+ Cell Depleted Bone Marrow Transplant From Partially HLA Matched Cadaveric Donors (RTB-003)
In Brief
A Phase 2 clinical trial evaluating CD3/CD19 neg allogeneic BMT for Primary Immunodeficiency and PID. Completed, enrolled 5 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether bilateral orthotopic lung transplantation (BOLT) followed by cadaveric partially-matched CD3+/CD19+ depleted bone marrow transplant (BMT) is safe and effective for individuals aged 10 through 45 years with the diagnosis of primary immunodeficiency (PID) and end-stage lung disease. The enrollment goal: 8 participants who receive both BOLT and BMT.
Study Details
Timeline
Interventions
Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection, and cryopreserved for later marrow transplantation. BMT conditioning and transplantation will start at least 8 weeks or more post lung transplant - once the participant is clinically judged suitable to undergo BMT conditioning and transplantion.