Mesenchymal Stem Cell Therapy for Lung Rejection
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT02181712
Sponsor Protocol Number: 14-000025
About this study
To assess the safety and feasibility of mesenchymal stem cells therapy in patients with transplant related bronchiolitis obliteran syndrome (BOS).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age range: 18 - 75 years
- Gender: Male of female
- Target disease or condition: Lung transplant recipients with treatment refractory moderate to severe o-CLAD. Patient must have diagnosis of treatment refractory o-CLAD Subject must have failed a standard immunosuppression regimen for lung transplant recipients and authorization for use of and disclosure of PHI.
Exclusion Criteria
- Patients with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the MSC infusion or complete the study.
- Patient should not have cancer not deemed to be in remission (superficial skin cancer shall not be deemed an exclusion criteria).
- Evidence or history of autoimmune disorders independent of o-CLAD.
- Pregnant or breast-feeding.
- Positive screening for HIV Hepatitis B and Hepatitis C.
- Evidence of liver dysfunction; Liver profile showing alkaline phosphatase higher than 345 u/L, total bilirubin greater than 1.65 mg/dL, ALT greater than 275 units/L and AST great than 240 units/L.
- Evidence of significant cardiac dysfunction.
- Septicemia with high fever and hemodynamic instability.
- History of CMV pneumonitis.
- Patients who received any experimental therapy (drug or biologic) for any indication within 12 months of the study enrollment.
More information
Publications
Publications are currently not available