Status:
UNKNOWN
Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
Lead Sponsor:
Translational Biosciences
Conditions:
Asthma
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
PHASE2
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 induc...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02192736
Start Date
July 1 2014
End Date
October 1 2020
Last Update
June 26 2018
Active Locations (1)
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1
Punta Pacifica Hospital
Panama City, Panama