Mesenchymal Stem Cell Therapy for Lung Rejection

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes 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.
  • Site IRB
    • Jacksonville, Florida: 14-000025
    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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  1. Age range: 18 - 75 years
  2. Gender: Male of female
  3. Target disease or condition: Lung transplant recipients with treatment refractory moderate BOS. Patient must have diagnosis of treatment refractory BO/BOS Subject must have had, for each of the following three (3) treatment categories, either an inadequate or lost response (recurrence or persistence of symptoms) to a drug in that category within the past 24 months or documented intolerance to a drug in that category at any time. Note that subject may currently be receiving steroids or immunomodulators (see dosage requirements below) at the time of enrollment.
  4. Enhanced steroid therapy
  5. Enhanced immunosuppression
  6. Trial/failure to other therapies like Azythromycin, anti-reflux therapy and others.
  7. Informed consent form (ICF): Each patient will be required to sign an IRB approved ICF. Only subjects who have signed the ICF will be enrolled into the study. The ICF will include elements required by Mayo IRB and FDA in US 21CFR50.
  8. Subject must have adequate renal function; calculated creatinine clearance of greater than 30 ml/min.
  9. Subject must be available for all specified assessments at the study site through the completion of the study.
  10. Subject must provide written ICF and authorization for use of and disclosure of PHI.

Exclusion Criteria

  1. 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
  2. Evidence or history of malignancy
  3. Evidence or history of autoimmune disorders independent of BO/BOS
  4. Pregnant or breast-feeding
  5. Positive screening for HIV Hepatitis B and Hepatitis C
  6. 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.
  7. Evidence of significant cardiac dysfunction
  8. Septicemia with high fever and hemodynamic instability
  9. History of CMV pneumonitis
  10. Patients who received any experimental therapy (drug or biologic) for any indication within 3 months of the study enrollment

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Abba Zubair, M.D., Ph.D.

Closed for enrollment

Contact information:

Dana Kontras M.S.N., R.N.

(904)953-8557

Kontras.Dana@mayo.edu

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CLS-20119367

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