Mesenchymal Stem Cell Therapy for Lung Rejection

NCT02181712 | Completed Phase 1 FDA Drug

• 1 other identifier: 14-000025
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and feasibility of mesenchymal stem cells therapy in patients with transplant related bronchiolitis obliteran syndrome (BOS)

Conditions

Lung Transplant Reject; Bronchiolitis Obliterans

Keywords

Bronchiolitis obliterans; lung transplant; mesenchymal stem cell; cell therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants with serious and non-serious adverse events

  Patients will be assessed for their capacity to tolerate IV infusion of MSC without acute clinical or physiological deterioration.

  Up to 2 weeks

• Changes in pulmonary function tests

  Vital signs, pulmonary function tests (FEV1 and FCV) and Borg Dyspnea Index will be evaluated. Chest Radiograph, CBC and serum chemistry will be performed.

  Up to 2 weeks

Study Arms (2)

Mesenchymal Stem cells

EXPERIMENTAL

Subjects who have never received Mesenchymal Stem Cells

Biological: Mesenchymal stem cell 0.5; Biological: Mesenchymal stem cell 1.0

Booster Mesenchymal Stem Cells

EXPERIMENTAL

Subjects who have previously received Mesenchymal Stem Cells

Biological: Mesenchymal stem cell 1.0

Interventions

Mesenchymal stem cell 0.5 BIOLOGICAL

0.5 million MSC per Kg will be infused intravenously. Product will be infused at the rate of 2 - 3 ml/minute during the first 15 minutes and may be adjusted up to 5ml/minutes if tolerable. It is anticipated that the infusion will be completed within approximately 3 hours.

Mesenchymal Stem cells

Mesenchymal stem cell 1.0 BIOLOGICAL

1 million MSC per Kg will be infused intravenously. Product will be infused at the rate of 2 - 3 ml/minute during the first 15 minutes and may be adjusted up to 5ml/minutes if tolerable. It is anticipated that the infusion will be completed within approximately 3 hours.

Booster Mesenchymal Stem Cells; Mesenchymal Stem cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. Note that subject may currently be receiving steroids or immunomodulators (see dosage requirements below) at the time of enrollment.
• The patient has persistent symptoms of BOS despite trials of other agents such asAzythromycin, anti-reflux therapy and others.
• 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.
• Subject must have adequate renal function; estimated glomerular filtrate rate of greater than 30 ml/min.
• Subject must be available for all specified assessments at the study site through the completion of the study.
• Subject must provide written ICF and authorization for use of and disclosure of PHI.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• David Erasmus, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: July 1, 2014
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Locations

US (1)