Clinical trial NCT02192736: Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
Official title: Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Asthma
Keywords: asthma
umbilical cord
mesenchymal
stem cells
trophic factors
Lead sponsor: Translational Biosciences
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Number of patients with a change in pulmonary function from baseline as measured by Forced Expiratory Volume (FEV1) following American Thoracic Society (ATS) guidelines
timeFrame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
measure: Number of patients with a change in pulmonary function from baseline as measured by Forced Vital Capacity (FVC) following American Thoracic Society (ATS) guidelines
timeFrame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh
measure: Number of patients with a change in quality of life from baseline as measured by the University of Pittsburgh Medical Center (UPMC) Asthma Questionnaire
timeFrame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Punta Pacifica Hospital
Study officials:
affiliation: Punta Pacifia Hospital in Panama City, Panama
name: Moises Zebede, MD
role: PRINCIPAL_INVESTIGATOR
References: