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

NCT02192736 | Unknown Phase 1 DMC

• 1 other identifier: TBS-MTFAS-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; umbilical cord; mesenchymal; stem cells; trophic factors

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  Evaluated 1 month after the final treatment

  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

  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

  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

  a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month

Study Arms (1)

Intra-nasal infusion of MTF

OTHER

Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally

Biological: Trophic factors from umbilical cord mesenchymal stem cells

Interventions

Trophic factors from umbilical cord mesenchymal stem cells BIOLOGICAL

Intra-nasal infusion of MTF

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Biosciences: lead

Study Sites (1)

Punta Pacifica Hospital

Panama City, Panama

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Moises Zebede, MD

  Punta Pacifia Hospital in Panama City, Panama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 17, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

PA (1)