Back to resultsSafety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
Primary Purpose
Asthma
Status
Unknown status
Phase
Phase 1
Locations
Panama
Study Type
Interventional
Intervention
Trophic factors from umbilical cord mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, umbilical cord, mesenchymal, stem cells, trophic factors
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
Sites / Locations
- Punta Pacifica Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intra-nasal infusion of MTF
Arm Description
Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally
Outcomes
Primary Outcome Measures
Number of patients with adverse events
Evaluated 1 month after the final treatment
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02192736
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Biosciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, umbilical cord, mesenchymal, stem cells, trophic factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra-nasal infusion of MTF
Arm Type
Other
Arm Description
Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally
Intervention Type
Biological
Intervention Name(s)
Trophic factors from umbilical cord mesenchymal stem cells
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
Evaluated 1 month after the final treatment
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of patients with a change in pulmonary function from baseline as measured by Forced Expiratory Volume (FEV1) following American Thoracic Society (ATS) guidelines
Description
After first treatment
After final treatment
Time Frame
a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
Title
Number of patients with a change in pulmonary function from baseline as measured by Forced Vital Capacity (FVC) following American Thoracic Society (ATS) guidelines
Description
After first treatment
After final treatment
Time Frame
a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh
Title
Number of patients with a change in quality of life from baseline as measured by the University of Pittsburgh Medical Center (UPMC) Asthma Questionnaire
Description
After first treatment
After last treatment
Time Frame
a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moises Zebede, MD
Organizational Affiliation
Punta Pacifia Hospital in Panama City, Panama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Punta Pacifica Hospital
City
Panama City
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
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