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

June 25, 2018 updated by: Translational Biosciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama
        • Punta Pacifica Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: 1 month
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
Time Frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
  1. After first treatment
  2. 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
Time Frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh
  1. After first treatment
  2. 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
Time Frame: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
  1. After first treatment
  2. After last treatment
a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Biosciences

Investigators

  • Principal Investigator: Moises Zebede, MD, Punta Pacifia Hospital in Panama City, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBS-MTFAS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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