What side effects are associated with this type of intervention?

Common treatments for asthma, particularly those involving immunomodulation and tissue repair such as Allogeneic Cord Tissue Derived MSCs and Interferon-γ Primed Bone Marrow MSCs, can have side effects including hypersensitivity reactions, which may manifest as allergic responses. Other potential side effects include infection risks due to immunosuppression, and mild systemic allergic reactions. General asthma treatments, such as inhaled corticosteroids, can cause oral thrush, hoarseness, and in some cases, systemic effects like adrenal suppression and osteoporosis with long-term use.

What prior FDA approvals exist?

The FDA has approved several treatments for asthma that focus on immunomodulation and tissue repair. Notably, biologics such as omalizumab (Xolair), mepolizumab (Nucala), and dupilumab (Dupixent) target specific pathways in the immune system to reduce inflammation and improve asthma control. These biologics work by inhibiting IgE or interleukins like IL-5 and IL-4/IL-13, which are involved in the inflammatory process of asthma. While these treatments are not stem cell-based, they share the goal of modulating the immune response to manage asthma symptoms and prevent exacerbations.

What other types of research exist?

Promising novel alternatives for asthma treatment in 2024 include biologic therapies such as monoclonal antibodies targeting specific inflammatory pathways (e.g., IL-5, IL-4, and IL-13 inhibitors), gene therapy approaches aimed at correcting genetic defects associated with asthma, and advanced inhaled therapies delivering targeted anti-inflammatory or bronchodilatory agents. Additionally, personalized medicine approaches using patient-specific data to tailor treatments may also offer significant advancements.

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Mesenchymal Stromal Cells

MSC Therapy for Asthma

Phase 1

Recruiting

Led By Edwin Horwitz, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Onset of asthma during childhood

Moderate-to-severe persistent asthma as defined by the National Asthma Education and Prevention Program Expert Panel Report-4

Must not have

Receiving allergen immunotherapy other than an established maintenance regimen (continuous regimen for ≥ 3 months)*

Use of medications known to significantly interact with corticosteroid disposition within the two-week period prior to the screening visit, including but not limited to carbamazepine, erythromycin or other macrolide antibiotics, phenobarbital, phenytoin, rifampin, and ketoconazole*

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the infusion, during the observation interval after the infusion (2 hours postinfusion), one day after the infusion, and at 7 to 30 days after the infusion (study day 14 to 37)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions related to cell therapy such as immune responses, infusion-related reactions, and possible toxicity affecting different organs which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My asthma started when I was a child.

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I have moderate-to-severe asthma.

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I am between 18 and 30 years old.

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I have been diagnosed with asthma by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been on a stable allergy shot regimen for at least 3 months.

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I haven't taken drugs like carbamazepine or erythromycin in the last two weeks.

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I have a history of eye issues or conditions worsened by steroids.

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I am a woman using birth control or practicing abstinence.

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I have a lung condition that is not asthma.

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My asthma control has worsened, shown by tests or an asthma attack.

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I do not have major health issues apart from asthma that would risk my participation in the study.

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I cannot participate in all required study activities.

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My body has shown a reaction to certain transplant materials.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the infusion, during the observation interval after the infusion (2 hours postinfusion), one day after the infusion, and at 7 to 30 days after the infusion (study day 14 to 37)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the infusion, during the observation interval after the infusion (2 hours postinfusion), one day after the infusion, and at 7 to 30 days after the infusion (study day 14 to 37)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the infusion, during the observation interval after the infusion (2 hours postinfusion), one day after the infusion, and at 7 to 30 days after the infusion (study day 14 to 37) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of adverse events and severe adverse events post-intervention

Number of grade ≥3 adverse reaction attributable to the γMSC product

Secondary study objectives

Biophysical characteristics of the cell products and correlation with clinical outcome

Change in lung function test

Circulating inflammatory cells of MSC treatment

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Albuterol Sulfate

2002

Completed Phase 3

~770

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for asthma, such as Allogeneic Cord Tissue Derived MSCs and Interferon-γ Primed Bone Marrow MSCs, primarily function through immunomodulation and tissue repair. These treatments help control the inflammatory process and promote the repair of damaged lung tissue, which is crucial for asthma patients. By reducing inflammation and enhancing tissue repair, these therapies can potentially improve lung function and reduce asthma symptoms, leading to better overall disease management and quality of life for patients.

Application of modified mesenchymal stem cells transplantation in the treatment of liver injury.Lung Tissue Damage Associated with Allergic Asthma in BALB/c Mice Could Be Controlled with a Single Injection of Mesenchymal Stem Cells from Human Bone Marrow up to 14 d After Transplantation.