AsthmaNCT04883320
Stem Cell Strategies for the Treatment of Chronic Asthma
An observational study of Asthma, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2016to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
Official title: Exploring the Role of Stem Cell Strategies for the Treatment of Chronic Asthma
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).
Read the detailed description
Asthma is a significant global health challenge with the prevalence of allergic asthma increasing by 1% each year. Atopic asthma is a complex disorder driven by cellular mechanisms in response to allergens. The response is two-fold; a chronic inflammatory response accompanied by remodelling of the respiratory airways. Airway remodelling is characterised by smooth muscle hypertrophy (and mucous gland) and hyperplasia, fibrosis of the sub-epithelium and reticular basement thickening, and epithelial damage. Over time the airway suffers remodelling due to thickening of the smooth muscle component which is in turn accompanied by irreversible fibrotic changes and a tendency towards treatment unresponsiveness. The inflammatory response on the other hand is characterised by IgE activation of mucous mast cells, infiltration of eosinophils, increased CD4+Th2 lymphocytes, and Type 2 cytokine secretion (e.g. IL13). The primary challenge in the development of new asthma treatments is to deliver long-lasting relief to the inflammatory response and also to 'repair' the remodelling associated with repeated asthmatic events. Mesenchymal stem cells (MSC), derived primarily from the bone marrow, have a multipotent differentiation potential (primarily bone, fat, and cartilage) and are currently in clinical trial for over 350 diseases and disorders. These include diverse areas such as ischemic stroke, graft vs. host disease, Crohns disease, and type 1 diabetes alongside anticipated applications related to the musculoskeletal system. Their application into the treatment of musculoskeletal damage relies primarily on functional incorporation (differentiation into the damaged tissue to repair in situ). In contrast their application in many other instances is due to their unique inherent characteristic, namely their immunomodulatory role. MSC secrete a wide range of growth factors and cytokines (the secretome) which have the capacity to silence immune reactions preventing T cell activation. In addition to this property the MSC secretome has also been shown to reverse the remodelling associated with fibrotic disease.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described | |
| participants with severe asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through to study completion, average of one year
Secondary outcomes (1)
Develop in virto models
Our secondary objective is to develop in vitro models derived from patient materials obtained by brush and biopsied airway epithelium and bronchial airway cells via BAL from patients with established history of asthma and atopy and commercially sourced MSCs.
Measured: Through to study completion, average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start31 Aug 2016
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883320
- Sponsor's protocol ID
- 1175
- Status last verified
- Feb 2025
- First submitted
- 30 Apr 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Stem Cell Strategies for the Treatment of Chronic Asthma
- ClinicalTrials.gov ID
- NCT04883320
- Acronym / sponsor ID
- 1175
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Asthma is a significant global health challenge with the prevalence of allergic asthma increasing by 1% each year. Atopic asthma is a complex disorder driven by cellular mechanisms in response to allergens. The response is two-fold; a chronic inflammatory response accompanied by remodelling of the respiratory airways. Airway remodelling is characterised by smooth muscle hypertrophy (and mucous gland) and hyperplasia, fibrosis of the sub-epithelium and reticular basement thickening, and epithelial damage. Over time the airway suffers remodelling due to thickening of the smooth muscle component which is in turn accompanied by irreversible fibrotic changes and a tendency towards treatment unresponsiveness. The inflammatory response on the other hand is characterised by IgE activation of mucous mast cells, infiltration of eosinophils, increased CD4+Th2 lymphocytes, and Type 2 cytokine secretion (e.g. IL13). The primary challenge in the development of new asthma treatments is to deliver long-lasting relief to the inflammatory response and also to 'repair' the remodelling associated with repeated asthmatic events. Mesenchymal stem cells (MSC), derived primarily from the bone marrow, have a multipotent differentiation potential (primarily bone, fat, and cartilage) and are currently in clinical trial for over 350 diseases and disorders. These include diverse areas such as ischemic stroke, graft vs. host disease, Crohns disease, and type 1 diabetes alongside anticipated applications related to the musculoskeletal system. Their application into the treatment of musculoskeletal damage relies primarily on functional incorporation (differentiation into the damaged tissue to repair in situ). In contrast their application in many other instances is due to their unique inherent characteristic, namely their immunomodulatory role. MSC secrete a wide range of growth factors and cytokines (the secretome) which have the capacity to silence immune reactions preventing T cell activation. In addition to this property the MSC secretome has also been shown to reverse the remodelling associated with fibrotic disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall aim of this proposal is to determine the effects of adult stem cell products on asthmatic respiratory epithelium.
Time frame: Through to study completion, average of one year
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.
1 secondary outcome
Develop in virto models
Time frame: Through to study completion, average of one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall aim of this proposal is to determine the effects of adult stem cell products on asthmatic respiratory epithelium. (time frame: Through to study completion, average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.