12 Participants Needed

MSC Therapy for Asthma

AF
Overseen ByAnne Fitzpatrick, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing the safety of using special stem cells to treat children and young adults with severe asthma that doesn't improve with regular treatments. The stem cells are given through an IV and may help reduce inflammation in the airways. The study aims to find out if this new treatment is safe and effective.

Do I need to stop my current medications for the trial?

The trial requires that you stop using oral or injectable corticosteroids and certain other medications that interact with corticosteroids at least two weeks before the screening visit. Nasal corticosteroids can be used during the trial, and you should not start new asthma therapies until 7 days after the γMSC infusion.

What data supports the effectiveness of the treatment Interferon gamma-primed mesenchymal stromal cells (MSCs) for asthma?

Research shows that low doses of interferon-gamma (a protein that helps regulate the immune system) can reduce inflammation in the airways of mice with asthma. This suggests that treatments involving interferon-gamma, like the one in the trial, might help manage asthma symptoms by reducing airway inflammation.12345

Is MSC therapy generally safe for humans?

The safety of mesenchymal stem cells (MSCs) for asthma treatment has not been confirmed in the studies reviewed, as they primarily focus on animal models and do not provide specific safety data for humans.678910

How is the treatment with Interferon gamma-primed mesenchymal stromal cells (MSCs) different from other asthma treatments?

This treatment is unique because it uses mesenchymal stromal cells (MSCs) that are primed with interferon gamma, which may help modulate immune responses in asthma by reducing inflammation and airway hyperreactivity, offering a novel approach compared to traditional asthma therapies that primarily focus on symptom relief.1341112

Research Team

EH

Edwin Horwitz, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for individuals aged 18-30 with moderate-to-severe persistent asthma diagnosed in childhood and evidence of atopy. Participants must not have other chronic lung diseases, be on new biologic asthma therapies, or have used oral/injectable corticosteroids within two weeks prior to screening. Women must use birth control if applicable.

Inclusion Criteria

My asthma started when I was a child.
I have moderate-to-severe asthma.
I am between 18 and 30 years old.
See 2 more

Exclusion Criteria

I have been on a stable allergy shot regimen for at least 3 months.
I haven't taken drugs like carbamazepine or erythromycin in the last two weeks.
I have a history of eye issues or conditions worsened by steroids.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive a single intravenous infusion of γMSCs at either 2x10^6 cells/kg or 5x10^6 cells/kg

1 day
1 visit (in-person)

Observation

Participants are observed for adverse reactions and safety assessments post-infusion

7 to 30 days
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lung function tests and analysis of inflammatory markers

1 year
Up to 12 visits (in-person)

Treatment Details

Interventions

  • Interferon gamma-primed mesenchymal stromal cells (MSCs)
Trial OverviewThe study tests the safety and optimal dose of two types of mesenchymal stromal cells (MSCs) treatments: one derived from cord tissue (cMSCs), another primed with interferon gamma from bone marrow (γMSCs). It's a Phase I trial with children receiving escalating doses to assess tolerance.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Infusion of γMSCsExperimental Treatment3 Interventions
Escalating doses Dose escalation design with two dose levels. The low dose level involves a single intravenous infusion of γMSCs at 2x106 cells/kg. The high dose level involves a single intravenous infusion of γMSCs at 5x106 cells/kg.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

The Marcus Foundation

Collaborator

Trials
19
Recruited
2,200+

Ossium Health, Inc.

Industry Sponsor

Trials
11
Recruited
200+

Findings from Research

Mucosal IFN-gamma gene transfer in a mouse model of allergic asthma significantly increases IFN-gamma expression in the lungs, which is crucial for combating airway inflammation.
This gene transfer method effectively reduces both eosinophilia and airway hyperreactivity caused by allergens and Th2 cells, indicating its potential as a novel therapy for allergic asthma.
Mucosal IFN-gamma gene transfer inhibits pulmonary allergic responses in mice.Li, XM., Chopra, RK., Chou, TY., et al.[2008]
In a double-blind study involving 30 patients with bronchial asthma, 20 injections of recombinant IFN-gamma significantly reduced skin wheal area, indicating potential anti-allergic effects.
However, IFN-gamma did not have any impact on allergic bronchoconstriction, suggesting that while it may help with skin reactions, it does not alleviate breathing difficulties associated with asthma.
[Effect of recombinant gamma interferon on allergic skin reaction and bronchoconstriction].Scholz, D., Brandt-Höfflin, K., Hahn, HL.[2011]
Low doses of exogenous interferon (IFN)-γ significantly reduced airway inflammation in an asthma model by decreasing inflammatory cell infiltration and Th2 cytokine production, as shown in a study with 42 mice.
The mechanism involves enhancing Fas/FasL-induced apoptosis in CD4(+) T cells, indicating that low doses of IFN-γ can effectively modulate immune responses in asthma without disrupting the Th1/Th2 balance.
Low doses of exogenous interferon-γ attenuated airway inflammation through enhancing Fas/FasL-induced CD4+ T cell apoptosis in a mouse asthma model.Yao, Y., Lu, S., Li, H., et al.[2021]

References

Mucosal IFN-gamma gene transfer inhibits pulmonary allergic responses in mice. [2008]
[Effect of recombinant gamma interferon on allergic skin reaction and bronchoconstriction]. [2011]
Low doses of exogenous interferon-γ attenuated airway inflammation through enhancing Fas/FasL-induced CD4+ T cell apoptosis in a mouse asthma model. [2021]
Inhaled delivery of recombinant interferon-lambda restores allergic inflammation after development of asthma by controlling Th2- and Th17-cell-mediated immune responses. [2023]
Long-Term Use of Maintenance Systemic Corticosteroids is Associated with Multiple Adverse Conditions in a Large, Real-World Cohort of US Adults with Severe Asthma. [2022]
Therapeutic administration of bone marrow-derived mesenchymal stromal cells reduces airway inflammation without up-regulating Tregs in experimental asthma. [2019]
Mesenchymal stem cell transfer suppresses airway remodeling in a toluene diisocyanate-induced murine asthma model. [2022]
Pollen-induced antigen presentation by mesenchymal stem cells and T cells from allergic rhinitis. [2020]
Mesenchymal stem cells abrogate experimental asthma by altering dendritic cell function. [2018]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Evaluation of Human MSCs Treatment Frequency on Airway Inflammation in a Mouse Model of Acute Asthma. [2021]
Inhaled delivery of Interferon-lambda restricts epithelial-derived Th2 inflammation in allergic asthma. [2020]
Interferon-alpha inhibits airway eosinophilia and hyperresponsiveness in an animal asthma model [corrected]. [2021]