Mesenchymal Stem Cell Therapy for Lung Rejection

Overview

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

David Erasmus, M.B., Ch.B., M.D.

Open for enrollment

Contact information:

Dana Kontras D.N.P., M.S.N., R.N., C.C.R.C.

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available