Last updated on April 2020

Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Lung Allograft Dysfunction (CLAD) | Chronic Lung Allograft Dysfunction
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Bilateral lung transplant recipients aged 18 years and at least 6 months post-transplant. Patients with other organs transplanted (eg heart, liver, kidney) or those who have undergone lobar transplantation, or re-transplantation, are potentially eligible.
  2. New-onset CLAD (defined as a persistent (3weeks apart) fall in FEV1 of at least 20% from the mean of the two best post-transplant values taken at least 3 weeks apart) in the 12 months prior to the screening visit. Other causes of a fall in FEV1 (acute cellular or humoral rejection, active infection, anastomotic stenosis etc.) must be excluded as per international guidelines.
  3. Stable immunosuppression regimen, as assessed by the investigator, in the 8 weeks prior to the screening visit.
  4. Available for all specified assessments at the study site through the completion of the study, including the protocol bronchoscopies.
  5. Provision of written informed consent.

Exclusion Criteria:

  1. Any condition that in the opinion of the Investigator may interfere with the safety of the patient, his / her completion of required follow-up visits or evaluation of the study objectives
  2. Untreated cellular or humoral rejection
  3. Clinically meaningful and untreated viral, bacterial or fungal infection
  4. Use of azithromycin or another macrolide antibiotic, if commenced within 8 weeks of the screening visit
  5. Intravenous pulsed methylprednisolone, within 4 weeks of the screening visit
  6. Use of extracorporeal photopheresis, within 4 weeks of the screening visit
  7. Use of total lymphoid irradiation, within 4 weeks of the screening visit
  8. Poor functional status not expected to survive 6 months
  9. Allergy to beef products
  10. Women who are pregnant, breast-feeding or unwilling to use adequate contraception
  11. Patients who are currently participating in another interventional clinical trial

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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