Allogeneic Human Cells (hMSC) Via Intravenous Delivery in Patients With Mild Asthma

Stopped early · Phase 1

Conditions studied: Asthma

In brief

A Phase 1 investigation will be performed to test the safety of two doses of bone marrow-derived MSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.

Key facts

Study ID

NCT03137199

Run by

Marilyn Glassberg

People needed

3

Starts

2017-06-22

Expected to finish

2020-04-29

Last updated by the study team

2020-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent
• be between 18 and 65 years at the time of signing the Informed Consent
• have a clinical diagnosis of asthma prior to screening in accordance with the guidelines of the American Thoracic Society/European Respiratory Society
• ACQ over 1.25
• have a smoking history of less than 10 pack-years total and have not been smoking for at least the last 12 months
• Perform a positive methacholine challenge at screening and repeat positive methacholine challenge at baseline visit (14 days later)
• Have normal or mild obstructive spirometry
• Have normal right heart function as documented by Doppler echo or right heart catheterization
• If female, be surgically sterile, post-menopausal (more than 1 year), or practice double barrier methods of birth control
• Subjects may receive non-drug therapies including oxygen supplementation no greater than 2L/minute, and pulmonary rehabilitation
• Subjects may be on standard of care asthma medications including inhaled corticosteroids-long acting beta agonist at a dose not greater than 1 mg of a fluticasone equivalent

You may not qualify if…

• Have any active infection that is not treated
• Be unable to perform any of the assessments required for endpoint analysis.
• currently receive (or have received within four weeks of screening) experimental agents for the treatment of asthma
• be actively listed (or expecting to be listed in the near future) for transplant of any organ
• Have clinically important abnormal screening laboratory values : blood screening tests (Hematology, Chemistry, CBC including Eosinophil count) results that are not within normal limits (according to UMHC Laboratory Reference Ranges) 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 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
• Have a non-pulmonary condition that limits lifespan to less than a year.
• Have a history of drug or alcohol abuse within the past 24 months.
• Be serum positive for HIV, hepatitis BsAg or Viremia hepatitis C
• Be currently participating (or have participated within the previous 30 days) in an investigational therapeutic or device trial.
• Have hypersensitivity to dimethyl sulfoxide (DMSO)
• Have a resting oxygen saturation (SpO2) on room air of more than 93% at sea level or more than 88% at an altitude above 5,000 feet above sea level (1524 meters)

Where it is running

• University of Miami Miller School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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