Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non-Cystic Fibrosis Bronchiectasis

Completed · Phase 1

Conditions studied: Bronchiectasis

In brief

To demonstrate the safety of bone marrow-derived allogeneic human Mesenchymal Stem Cells (hMSCs) in patients with bronchiectasis receiving standard of care therapy, and to explore treatment efficacy

Key facts

Study ID

NCT02625246

Run by

Marilyn Glassberg

People needed

6

Starts

2016-02-04

Expected to finish

2019-05-15

Last updated by the study team

2019-08-28

Who can join

Age: 30 and older, up to 87. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent,
• be between 30 and 87 years old at the time of signing the Informed Consent,
• weight over 45 and under 150 kg,
• have a clinical diagnosis of non-CF bronchiectasis prior to screening,
• Have had at least 2 exacerbations in the past year as documented by physician office or hospital visits (Use of antibiotics of at least one time in the last year),
• Show a baseline FEV1 between 25% and 85% predicted and over or equal to 1 L and a baseline diffusion capacity of lung for carbon monoxide (DLCO) over or equal to 30% (corrected for hemoglobin but not alveolar volume),
• Have a normal Right Ventricular function, as documented by Doppler echo or right heart catheterization,
• if a female of childbearing potential, agree to abide by contraception rules defined below.
• Subjects may receive nondrug therapies including oxygen supplementation not greater than 4 Liters per minute and pulmonary rehabilitation.
• Subjects may be on chronic macrolide or inhaled antibiotic treatment bronchiectasis

You may not qualify if…

• Have HRCT and or surgical lung biopsy results inconsistent with the diagnosis of non-CF bronchiectasis. (Exclusion of emphysema and or diffuse parenchymal disease)
• be unable to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform Pulmonary Function Tests (PFT) or HRCT, undergo blood draws, read and respond to questionnaire
• If a female of childbearing potential, have a follicle stimulating hormone (FSH) under 25.8 IU/L
• be actively treated for an acute infectious exacerbation of bronchiectasis
• Have an active infection that is not treated
• Have had active infections occurring within a minimum of 4 weeks of study treatment
• Be currently on treatment for NTM infections
• Have had positive sputum cultures for nontuberculous mycobacterial (NTM) within the past 6 months
• Have a history of drug or alcohol abuse within the past 24 months.
• Be currently receiving (or have received within four weeks of screening) experimental agents for the treatment of bronchiectasis or have been enrolled in clinical trials within the previous 30 days
• Be actively listed (or expect future listing) for transplant of any organ.
• Have clinically important abnormal screening laboratory values.
• Have a serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
• Have any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
• Have known allergies to penicillin or streptomycin.
• Be an organ transplant recipient.
• Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or cervical carcinoma.
• Have a non-pulmonary condition that limits lifespan to less than 1 year.
• Be serum positive for HIV, hepatitis BsAg (surface agent reactive) or Viremic hepatitis C.
• Have hypersensitivity to dimethyl sulfoxide (DMSO)
• Be unable to maintain saturated oxygen (SpO2) of more than 93% on room air at sea level at rest) or an SpO2 of more than 88% on room air over 5,000 feet (1524 meters) above sea level at rest.

Where it is running

• University of Miami Hospitals & Clinics — Miami, Florida, United States

Full record on ClinicalTrials.gov

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