Mesenchymal Stem Cell Therapy for Lung Rejection

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT02181712
• Date of registration: 02/07/2014
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Mesenchymal Stem Cell Therapy for Lung Rejection
• Scientific title: A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells to Induce Remission in Lung Transplant Patients Experiencing Treatment-refractory Moderate to Severe Lung Rejection
• Date of first enrolment: July 2014
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02181712
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David Erasmus, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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 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. Note that subject may currently be receiving steroids or immunomodulators
(see dosage requirements below) at the time of enrollment.

4. The patient has persistent symptoms of BOS despite trials of other agents such
asAzythromycin, anti-reflux therapy and others.

5. 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.

6. Subject must have adequate renal function; estimated glomerular filtrate rate of
greater than 30 ml/min.

7. Subject must be available for all specified assessments at the study site through the
completion of the study.

8. 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. 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

3. Pregnant or breast-feeding

4. Positive screening for HIV Hepatitis B and Hepatitis C

5. 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.

6. Evidence of significant cardiac dysfunction

7. Septicemia with high fever and hemodynamic instability

8. History of CMV pneumonitis

9. Patients who received any experimental therapy (drug or biologic) for any indication
within 12 months of the study enrollment



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bronchiolitis Obliterans

Lung Transplant Reject

Intervention(s)

Biological: Mesenchymal stem cell 0.5

Biological: Mesenchymal stem cell 1.0

Primary Outcome(s)

Changes in pulmonary function tests [Time Frame: Up to 2 weeks]

Number of Participants with serious and non-serious adverse events [Time Frame: Up to 2 weeks]

Secondary ID(s)

14-000025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors