Actively Recruiting
Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure
Led by Paul Szabolcs · Updated on 2026-01-13
8
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of performing a lung transplantation followed by a partially matched, CD3+/CD19+ depleted bone marrow transplantation from the same cadaveric donor in patients with bone marrow failure and end-stage lung disease. The study focuses on individuals with idiopathic pulmonary fibrosis and related conditions who cannot undergo standard lung transplantation. The goal is to restore lung function before bone marrow transplantation and then to recover blood cell function after the bone marrow transplant. Participants will receive a lung transplant using standard induction treatments tailored to their health status, possibly including rituximab and tacrolimus for immune system management. At least eight weeks after the lung transplant, they will undergo bone marrow transplantation with marrow processed to remove specific immune cells. The bone marrow is recovered from the same donor as the lung and prepared using specialized devices to reduce immune complications. During the study, participants will be closely monitored for up to two years after stem cell transplantation. Researchers will assess survival, success of bone marrow engraftment, lung function, immune cell presence, blood cell recovery without growth factors, and complications related to both lung and bone marrow transplants. The study will also evaluate long-term immune tolerance, the ability to reduce or stop immunosuppressive drugs, and the occurrence of transplant rejection or graft-versus-host disease.
CONDITIONS
Brief Title
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Male or female aged 18 through 60 years at the time of consent
- Meet criteria for UNOS listing for lung transplantation
- Have end-stage lung disease such as pulmonary fibrosis or COPD/emphysema
- Evidence of bone marrow failure with low blood cell counts not caused by drugs, including neutropenia, thrombocytopenia, or anemia confirmed by repeat testing
- Glomerular filtration rate (GFR) of at least 45 mL/min/1.73 m2
- Liver function tests (AST, ALT) no higher than 4 times upper limit of normal, total bilirubin ≤ 2.5 mg/dL, normal INR, albumin over 3.0 g/dL
- Cardiac ejection fraction ≥ 40% or shortening fraction ≥ 26%
- Negative pregnancy test for females unless surgically sterilized
- Agree to use FDA-approved birth control for 24 months after bone marrow transplant if of childbearing potential
- Counseled about infertility risks and options for sperm or egg banking
You will not qualify if you...
- Unable or unwilling to provide written informed consent or comply with study protocol
- Have malignant conditions
- Have non-malignant conditions not requiring bone marrow transplant
- HIV positive or HTLV positive by testing (with HTLV confirmed by nucleic acid testing)
- Pregnant or lactating females
- Allergy to DMSO or any ingredient in stem cell product manufacturing
- Uncontrolled pulmonary infection or infection determined by imaging or testing
- Recent receipt of any live attenuated vaccine within 4 weeks of transplant
- Medical problems or test findings that increase risk or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with recovery period
Participants undergo a cadaveric, partially HLA-matched lung transplantation using standard induction regimens based on their health conditions and immune sensitization.
Approximately 1 transplant procedure and multiple follow-up visits as needed
Duration - Begins no less than 8 weeks post lung transplantation with conditioning and transplantation phases
Participants receive CD3+/CD19+ depleted bone marrow transplantation from the same donor, starting no less than 8 weeks after lung transplantation, following transplantation conditioning with drugs such as rituximab, alemtuzumab, fludarabine, thiotepa, G-CSF, and hydroxyurea.
Multiple visits for conditioning and transplantation procedures
Duration - Up to 2 years post bone marrow transplant
Participants are monitored for safety, efficacy, immune tolerance, graft function, and long-term complications including immunosuppression withdrawal and independence from growth factors or transfusions.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 2 locations
1
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15214
Actively Recruiting
2
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
P
Paul Szabolcs, M.D.
S
Shawna H McIntyre, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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