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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02192736
• Date of registration: 14/07/2014
• Prospective Registration: No
• Primary sponsor: Translational Biosciences
• Public title: Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
• Scientific title: Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
• Date of first enrolment: July 2014
• Target sample size: 20
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02192736
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Panama

Contacts

• Name: Moises Zebede, MD
• Affiliation: Punta Pacifia Hospital in Panama City, Panama

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Biological: Trophic factors from umbilical cord mesenchymal stem cells

Primary Outcome(s)

Number of patients with adverse events [Time Frame: 1 month]

Secondary Outcome(s)

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]

Secondary ID(s)

TBS-MTFAS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors