Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma

Translational Biosciences

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Asthma

Treatments

Biological: Trophic factors from umbilical cord mesenchymal stem cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT02192736

TBS-MTFAS-001

Details and patient eligibility

About

Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) administered intra-nasally to 20 patients is a safe and useful procedure for inducing improvements in pulmonary function and quality of life in patients with asthma.

Full description

The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic UC-MSC-derived MTF administered to patients with asthma. Each patient will receive intra-nasal MTF once per week for a period of 4 weeks.

Enrollment

20 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed consent form by the subject
Male or female
Between 18 and 65 years old and capability to comprehend this trial.
Asthma diagnosed by a physician at least 1 year prior to study enrollment
Poorly-controlled asthma at study enrollment. Poorly controlled asthma is defined as: chronic symptoms, episodic exacerbations, persistent and variable airways obstruction despite a continued requirement for short-acting beta 2-agonists despite the use of high doses of inhaled steroids.
Nonsmokers (stopped smoking at least 1 year ago) and limited life-time history of smoking (less than a 3 pack year history).
Body mass index 19-40
On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry or had to use a rescue dose during the last 4 weeks.
FEV1 >50% predicted

Exclusion criteria

Pregnant or lactating women
Cognitively impaired adults
Systemic steroids within the 4 weeks prior to enrollment
Non-steroidal anti-inflammatory drugs (NSAIDs) for arthritis
Current diagnosis of polyposis or sinusitis.
Infection treated by antibiotics within the 4 weeks prior to enrollment
Immunization within the 4 weeks prior to enrollment
Lung pathology other than asthma
Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction <50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum creatinine >3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
Illicit drug use within the past year
Current/active upper respiratory infection (URI) (if active URI, wait until asymptomatic for 1 week to enroll)
Asthma exacerbation within the 4 weeks prior to enrollment (includes ER, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months prior to enrollment will be allowed to participate)
Clinically significant abnormalities present on screening 12-lead electrocardiogram
Women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study
Participation in another clinical study within 4 weeks prior to enrollment
Subject does not sign informed consent