<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02192736</url>
  </required_header>
  <id_info>
    <org_study_id>TBS-MTFAS-001</org_study_id>
    <nct_id>NCT02192736</nct_id>
  </id_info>
  <brief_title>Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma</brief_title>
  <official_title>Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Translational Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Translational Biosciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived&#xD;
      mesenchymal stem cells (UC-MSC) administered intra-nasally to 20 patients is a safe and&#xD;
      useful procedure for inducing improvements in pulmonary function and quality of life in&#xD;
      patients with asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic&#xD;
      UC-MSC-derived MTF administered to patients with asthma. Each patient will receive&#xD;
      intra-nasal MTF once per week for a period of 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>1 month</time_frame>
    <description>Evaluated 1 month after the final treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month</time_frame>
    <description>After first treatment&#xD;
After final treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh</time_frame>
    <description>After first treatment&#xD;
After final treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month</time_frame>
    <description>After first treatment&#xD;
After last treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Intra-nasal infusion of MTF</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Trophic factors from umbilical cord mesenchymal stem cells</intervention_name>
    <arm_group_label>Intra-nasal infusion of MTF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed consent form by the subject&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Between 18 and 65 years old and capability to comprehend this trial.&#xD;
&#xD;
          -  Asthma diagnosed by a physician at least 1 year prior to study enrollment&#xD;
&#xD;
          -  Poorly-controlled asthma at study enrollment. Poorly controlled asthma is defined as:&#xD;
             chronic symptoms, episodic exacerbations, persistent and variable airways obstruction&#xD;
             despite a continued requirement for short-acting beta 2-agonists despite the use of&#xD;
             high doses of inhaled steroids.&#xD;
&#xD;
          -  Nonsmokers (stopped smoking at least 1 year ago) and limited life-time history of&#xD;
             smoking (less than a 3 pack year history).&#xD;
&#xD;
          -  Body mass index 19-40&#xD;
&#xD;
          -  On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry&#xD;
             or had to use a rescue dose during the last 4 weeks.&#xD;
&#xD;
          -  FEV1 &gt;50% predicted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Cognitively impaired adults&#xD;
&#xD;
          -  Systemic steroids within the 4 weeks prior to enrollment&#xD;
&#xD;
          -  Non-steroidal anti-inflammatory drugs (NSAIDs) for arthritis&#xD;
&#xD;
          -  Current diagnosis of polyposis or sinusitis.&#xD;
&#xD;
          -  Infection treated by antibiotics within the 4 weeks prior to enrollment&#xD;
&#xD;
          -  Immunization within the 4 weeks prior to enrollment&#xD;
&#xD;
          -  Lung pathology other than asthma&#xD;
&#xD;
          -  Other significant non-pulmonary co-morbidities such as: coronary artery disease,&#xD;
             peripheral vascular disease, cerebrovascular disease, congestive heart failure with an&#xD;
             ejection fraction &lt;50%, liver disease or elevated liver enzymes at baseline,&#xD;
             malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum&#xD;
             creatinine &gt;3.0, or disorders requiring steroid treatment such as vasculitis, lupus,&#xD;
             rheumatoid arthritis&#xD;
&#xD;
          -  Illicit drug use within the past year&#xD;
&#xD;
          -  Current/active upper respiratory infection (URI) (if active URI, wait until&#xD;
             asymptomatic for 1 week to enroll)&#xD;
&#xD;
          -  Asthma exacerbation within the 4 weeks prior to enrollment (includes ER, urgent care,&#xD;
             or hospital visits due to asthma resulting in an increase in asthma-related&#xD;
             medications)&#xD;
&#xD;
          -  Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea&#xD;
             (patients on a stable treatment regimen for sleep apnea for the last 3 months prior to&#xD;
             enrollment will be allowed to participate)&#xD;
&#xD;
          -  Clinically significant abnormalities present on screening 12-lead electrocardiogram&#xD;
&#xD;
          -  Women of childbearing potential using oral contraceptives who are not willing to use a&#xD;
             second method of contraception during the study&#xD;
&#xD;
          -  Participation in another clinical study within 4 weeks prior to enrollment&#xD;
&#xD;
          -  Subject does not sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moises Zebede, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Punta Pacifia Hospital in Panama City, Panama</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Punta Pacifica Hospital</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Panama</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>June 25, 2018</last_update_submitted>
  <last_update_submitted_qc>June 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>umbilical cord</keyword>
  <keyword>mesenchymal</keyword>
  <keyword>stem cells</keyword>
  <keyword>trophic factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02192736
org study id: TBS-MTFAS-001
nct id: NCT02192736
lead sponsor: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with adverse events
time frame: 1 month
description: Evaluated 1 month after the final treatment
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
time frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
description: After first treatment
After final treatment
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
time frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh
description: After first treatment
After final treatment
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
time frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
description: After first treatment
After last treatment
arm group label: Intra-nasal infusion of MTF
arm group type: Other
description: Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally
intervention type: Biological
intervention name: Trophic factors from umbilical cord mesenchymal stem cells
arm group label: Intra-nasal infusion of MTF
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Moises Zebede, MD
role: Principal Investigator
affiliation: Punta Pacifia Hospital in Panama City, Panama
facility: 
country: Panama
responsible party type: Sponsor
mesh term: Asthma