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

Marilyn Glassberg

Status and phase

Terminated

Phase 1

Conditions

Asthma

Treatments

Biological: hMSCs

Study type

Interventional

Funder types

Other

Identifiers

NCT03137199

20160350

Details and patient eligibility

About

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.

Full description

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 peripheralintravenous infusion.

Group 1: 3 subjects will receive a single administration of allogeneic hMSCs: 20 million cells delivered via peripheral intravenous infusion Group 2: 3 subjects will receive a single administration of allogeneic hMSCs: 100 million cells delivered via peripheral intravenous infusion Interim safety analysis will be performed four weeks after the 1st subject is enrolled in each cohort. Continued safety and tolerability with review of adverse events (AEs) will be assessed at each visit. Efficacy parameters (pulmonary function tests, diffusing capacity (DLCO), lung volumes, 6-minute walk test (6MWT), and dyspnea/quality of life [QOL] questionnaires) will be assessed every 12 weeks until study completion. Clinical laboratory tests to assess safety will be performed at every visit.

Enrollment

3 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)