Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
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ClinicalTrials.gov Identifier: NCT02192736 |
Recruitment Status : Unknown
Verified June 2018 by Translational Biosciences.
Recruitment status was: Active, not recruiting
First Posted : July 17, 2014
Last Update Posted : June 26, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Biological: Trophic factors from umbilical cord mesenchymal stem cells | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma |
Study Start Date : | July 2014 |
Estimated Primary Completion Date : | April 2020 |
Estimated Study Completion Date : | October 2020 |
Arm | Intervention/treatment |
---|---|
Intra-nasal infusion of MTF
Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally
|
Biological: Trophic factors from umbilical cord mesenchymal stem cells |
- Number of patients with adverse events [ Time Frame: 1 month ]Evaluated 1 month after the final treatment
- Number of patients with a change in pulmonary function from baseline as measured by Forced Expiratory Volume (FEV1) following American Thoracic Society (ATS) guidelines [ Time Frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month ]
- 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 [ Time Frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh ]
- 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 [ Time Frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month ]
- After first treatment
- After last treatment

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Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192736
Panama | |
Punta Pacifica Hospital | |
Panama City, Panama |
Principal Investigator: | Moises Zebede, MD | Punta Pacifia Hospital in Panama City, Panama |
Responsible Party: | Translational Biosciences |
ClinicalTrials.gov Identifier: | NCT02192736 |
Other Study ID Numbers: |
TBS-MTFAS-001 |
First Posted: | July 17, 2014 Key Record Dates |
Last Update Posted: | June 26, 2018 |
Last Verified: | June 2018 |
asthma umbilical cord mesenchymal stem cells trophic factors |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |