NCT04883320Active, not recruiting
Stem Cell Strategies for the Treatment of Chronic Asthma
Exploring the Role of Stem Cell Strategies for the Treatment of Chronic Asthma
Source: ClinicalTrials.gov · Last updated 20 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 30 Apr 2021
- Start date
- 31 Aug 2016
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Diseases
- Asthma
- NCT number
- NCT04883320
What you commit to
- Study type: Observational
- Planned participants: 15
- From 31 Aug 2016 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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).
- 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:
- 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.
- 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).
- 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:
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of North Midlands NHS Trust Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.