Actively Recruiting
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
Led by Paul Szabolcs · Updated on 2026-01-13
8
Participants Needed
2
Research Sites
554 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether a lung transplantation prior to bone marrow transplantation (BMT) would allow for restoration of pulmonary function prior to BMT, allowing to proceed to BMT, to restore hematologic function.
CONDITIONS
Official Title
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be able to understand and provide informed consent
- Male or female, aged 18 through 60 years at consent
- Meet criteria for UNOS listing for lung transplantation
- Have evidence of end-stage lung disease such as pulmonary fibrosis or COPD/emphysema
- Have evidence of bone marrow failure with low blood cell counts in at least one hematopoietic line, including unexplained neutropenia, thrombocytopenia, or anemia confirmed by repeat testing
- Kidney function (GFR) of 45 mL/min/1.73 m2 or higher
- Liver function tests: AST and ALT less than 4 times upper limit of normal, total bilirubin 2.5 mg/dL or less, normal INR, albumin greater than 3.0 g/dL
- Cardiac ejection fraction 40% or greater or shortening fraction 26% or greater
- Negative pregnancy test for females unless surgically sterilized
- Females of childbearing potential and sexually active males must agree to use FDA-approved birth control for up to 24 months after BMT or while taking medications harmful to pregnancy
- Counseling provided on infertility risks and options for sperm banking or oocyte harvesting
You will not qualify if you...
- Unable or unwilling to provide written informed consent or follow study protocol
- Presence of underlying malignant conditions
- Non-malignant conditions not requiring bone marrow transplant
- HIV positive by serology or PCR, or HTLV positive by serology unless NAT confirms negative
- Females who are pregnant or breastfeeding
- Allergy to DMSO or any ingredient in the stem cell product
- Uncontrolled lung infection causing clinical deterioration
- Uncontrolled infection confirmed by imaging or testing
- Receipt of any live attenuated vaccine within 4 weeks prior to transplant
- Any other medical problems or findings that increase risk, interfere with participation, or affect data quality as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
S
Shawna H McIntyre, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here