AsthmaPhase 1/2NCT02192736
Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
A Phase 1/2 study testing Trophic factors from umbilical cord mesenchymal stem cells in people with Asthma, run by Translational Biosciences at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Trophic factors from umbilical cord mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePanama
- Study dates
- Jul 2014to 23 May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Trophic factors from umbilical cord mesenchymal stem cells
- Keywords
- asthma, umbilical cord, mesenchymal, stem cells, trophic factors
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trophic factors from umbilical cord mesenchymal stem cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Intra-nasal infusion of MTF | Other | Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally Receives: Biological: Trophic factors from umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Evaluated 1 month after the final treatment
Measured: 1 month
Secondary outcomes (3)
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
Measured: 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
- After first treatment
- After final treatment
Measured: 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
- After first treatment
- After last treatment
Measured: a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion23 May 2024
- Study completion23 May 2024
Why it stopped: Did not meet recruitment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moises Zebede, MD, Principal investigator, Punta Pacifia Hospital in Panama City, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192736
- Sponsor's protocol ID
- TBS-MTFAS-001
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2014
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
- ClinicalTrials.gov ID
- NCT02192736
- Acronym / sponsor ID
- TBS-MTFAS-001
- Conditions
- Asthma
- Keywords
- asthma, umbilical cord, mesenchymal, stem cells, trophic factors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet recruitment goals
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Translational BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-nasal infusion of MTF | Other | Biological: Trophic factors from umbilical cord mesenchymal stem cellsTrophic factors from umbilical cord mesenchymal stem cells administered intra-nasally |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trophic factors from umbilical cord mesenchymal stem cells | Biological | Intra-nasal infusion of MTF |
Primary outcome
Number of patients with adverse events
Time frame: 1 month
Evaluated 1 month after the final treatment
3 secondary outcomes
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
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
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
Results and safety
The study was stopped early (reason given: Did not meet recruitment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moises Zebede, MD principal investigator
Punta Pacifia Hospital in Panama City, Panama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trophic factors from umbilical cord mesenchymal stem cells in people with Asthma, run by Translational Biosciences at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Did not meet recruitment goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.