Clinical trial for Idiopathic Pulmonary Fibrosis
Official title Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
ClinicalTrials.gov ID: NCT03500731
What this study is testing
What is CD3/CD19 negative hematopoietic stem cells?
CD3/CD19 negative hematopoietic stem cells is an investigational medicine, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether doing a lung transplant first can restore lung function enough to allow a later bone‑marrow transplant and improve blood‑cell health.
- Who it's for
- Adults who have idiopathic pulmonary fibrosis or emphysema/COPD and are candidates for a bone‑marrow transplant.
- What's involved
- Participants will receive a lung transplant, then later a bone‑marrow transplant, with medical visits and tests to monitor lung and blood‑cell recovery.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Subject must be able to understand and provide informed consent.
- Male or female, 18 through 60 years old, inclusive, at the time of informed consent.
- Meet criteria for UNOS listing for lung transplantation.
- Pulmonary Fibrosis
- COPD/Emphysema
You likely can't join if
- Individuals who meet any of these criteria are not eligible for this study.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Patients who have underlying malignant conditions.
- Patients who have non-malignant conditions not requiring BMT.
- HIV positive by serology or PCR, HTLV positive by serology. If HTLV serology is positive, it will be confirmed by nucleic acid testing (NAT).
- Females who are pregnant or who are lactating.
See the full eligibility criteria
- Subject must be able to understand and provide informed consent.
- Male or female, 18 through 60 years old, inclusive, at the time of informed consent.
- Meet criteria for UNOS listing for lung transplantation.
- Pulmonary Fibrosis
- COPD/Emphysema
- Unexplained, non-drug induced neutropenia with absolute neutrophils counts of \<1500/µL the previous year, confirmed by repeat testing
- Unexplained, non-drug induced thrombocytopenia with mean platelets counts of \<100,000/µL the previous year, confirmed by repeat testing
- Unexplained, non-hemolytic anemia, with a hemoglobin level of \< 12 g/dL the previous year, confirmed by repeat testing
- GFR ≥45 mL/min/1.73 m2.
- AST, ALT ≤4x upper limit of normal, total bilirubin ≤ 2.5 mg/dL, normal INR, albumin \>3.0 g/dL
- Cardiac ejection fraction ≥ 40% or shortening fraction ≥26%.
- Negative pregnancy test for females, unless surgically sterilized.
- All females of childbearing potential and sexually active males must agree to use a FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a...
- Subject will also be counseled regarding the potential risks of infertility following BMT and advised to discuss sperm banking or oocyte harvesting.
- Individuals who meet any of these criteria are not eligible for this study.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Patients who have underlying malignant conditions.
- Patients who have non-malignant conditions not requiring BMT.
- HIV positive by serology or PCR, HTLV positive by serology. If HTLV serology is positive, it will be confirmed by nucleic acid testing (NAT).
- Females who are pregnant or who are lactating.
- Allergy to DMSO or any other ingredient used in the manufacturing of the stem cell product.
- Uncontrolled pulmonary infection, as determined by radiographic findings and/or significant clinical deterioration.
- Uncontrolled infection, as determined by the appropriate imaging and/or confirmatory testing e.g. blood cultures, PCR testing, etc.
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of transplant.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.