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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
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Biological: Trophic factors from umbilical cord mesenchymal stem cells Phase 1 Phase 2

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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 1 month ]
    Evaluated 1 month after the final treatment


Secondary Outcome Measures :
  1. 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 ]
    1. After first treatment
    2. After final treatment

  2. 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 ]
    1. After first treatment
    2. After final treatment

  3. 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 ]
    1. After first treatment
    2. After last treatment


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Panama
Punta Pacifica Hospital
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
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Principal Investigator: Moises Zebede, MD Punta Pacifia Hospital in Panama City, Panama
More Information
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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
Keywords provided by Translational Biosciences:
asthma
umbilical cord
mesenchymal
stem cells
trophic factors
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases