Stem Cell Strategies for the Treatment of Chronic Asthma

NCT04883320 | Active Not Recruiting

• 1 other identifier: 1175
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a pilot/laboratory study comparing the effects of MSC conditioned media on samples of airway cells in 3 participant groups with mild/moderate asthma (5 participants), severe asthma (5 participants), or no asthma (5 participants).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• The overall aim of this proposal is to determine the effects of adult stem cell products on asthmatic respiratory epithelium.

  Our primary objective is to determine this with in vitro models, where we will explore the utility of the MSC secretome in abrogating IgE and Type 2 cytokine driven immune responses and in reversing airway remodelling.

  Through to study completion, average of one year

Secondary Outcomes (1)

• Develop in virto models

  Through to study completion, average of one year

Study Arms (3)

participants with no asthma

Have no evidence of any long term lung condition or any other disabling condition and they must not have had a chest infection in the preceding 4 weeks.

participants with mild/moderate asthma

participants with severe asthma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Trial participants will be identified from those attending respiratory medicine outpatient clinics at the Royal Stoke University Hospital. Participants will donate samples of upper airway cells during bronchoscopy by biopsy, brush biopsy and bronchoalveolar lavage (BAL)

You may qualify if:

• Men or women, age (18-70 years old), II. Lifelong never-smokers or ex-smokers (\< 10 pack years). (1 pack year= 20 cigarettes/day for 1 year).
• III. Must be competent to give written informed consent. IV. Female participants of child bearing potential must have a negative urine pregnancy test prior to bronchoscopy.
• V Potential participants must meet the safety criteria to have a Spirometry test where necessary.
• vi Must meet the safety criteria to have a bronchoscopy.
• Asthmatic participants:
• VI. Have a physician diagnosis of asthma. VII. All asthma patients will have either bronchodilator reversibility of ≥12% or 200 mL at screening, or historic data confirming bronchodilator reversibility or bronchial hyperreactivity to methacholine (PC20). Those without prior confirmed reversibility will have bronchodilator reversibility testing to salbutamol at screening and the asthma control questionnaire (ACQ) administered. Where reversibility to salbutamol is inconclusive a methacholine challenge will be performed.
• VIII. Must have stable disease with no recent flare-ups (within 4 weeks). IX. Oxygen saturations whilst breathing room air must be \> 90% (a measure of how well the lungs are providing oxygen to the body).
• X. When blowing forcefully into a tube (forced expiratory volume or FEV), the patient must be able to blow out at least one litre of air in the first second (FEV1 \> 1Litre).
• Non-asthmatic participants:
• XI. Have no physician diagnosis of asthma. XII. Have no evidence of any long term lung condition or any other disabling condition and they must not have had a chest infection in the preceding 4 weeks.

You may not qualify if:

• I. Significant smoking history (\>10 pack year). II. Significant lung co-morbidities III. Patient unable to give informed consent IV. History of myocardial infarction within the preceding 6 weeks V. Any subject with asthma who requires home oxygen will not be included for safety reasons

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Airway cells will be obtained from participants during bronchoscopy via biopsy, brush biopsy and bronchoalveolar lavage (BAL). To minimise discomfort the procedure will utilise the sedative midazolam and local anaesthetic lidocaine.

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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 12, 2021
• Study Start: August 31, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

GB (1)