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

Study Overview
=================
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.

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

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Biological: Trophic factors from umbilical cord mesenchymal stem cells


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intra-nasal infusion of MTF<br>Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally | Biological: Trophic factors from umbilical cord mesenchymal stem cells<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | Evaluated 1 month after the final treatment | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a change in pulmonary function from baseline as measured by Forced Expiratory Volume (FEV1) following American Thoracic Society (ATS) guidelines | After first treatment After final treatment | a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month | 
| Number of patients with a change in pulmonary function from baseline as measured by Forced Vital Capacity (FVC) following American Thoracic Society (ATS) guidelines | After first treatment After final treatment | a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh | 
| Number of patients with a change in quality of life from baseline as measured by the University of Pittsburgh Medical Center (UPMC) Asthma Questionnaire | After first treatment After last treatment | a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, umbilical cord, mesenchymal, stem cells, trophic factors