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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 belowSelect...
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:Select...
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)
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 moreAwards & 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
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.
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.
Find a Location
Who is running the clinical trial?
The Marcus FoundationOTHER
16 Previous Clinical Trials
1,521 Total Patients Enrolled
1 Trials studying Asthma
3 Patients Enrolled for Asthma
Emory UniversityLead Sponsor
1,705 Previous Clinical Trials
2,607,372 Total Patients Enrolled
12 Trials studying Asthma
2,908 Patients Enrolled for Asthma
Ossium Health, Inc.Industry Sponsor
9 Previous Clinical Trials
136 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My asthma started when I was a child.I have a history of eye issues or conditions worsened by steroids.I haven't taken oral or injectable steroids in the last two weeks.I am a woman using birth control or practicing abstinence.I have a lung condition that is not asthma.My asthma control has worsened, shown by tests or an asthma attack.You are currently smoking or using a vape.I do not have major health issues apart from asthma that would risk my participation in the study.You have had bad reactions to corticosteroids or certain types of inhalers in the past.You have a significant decrease in platelets, red blood cells, or white blood cells when checked by the doctor.I have moderate-to-severe asthma.I am on new asthma treatments and will be until 7 days after a specific infusion.You were born before 35 weeks of pregnancy.I am between 18 and 30 years old.I have been diagnosed with asthma by a doctor.I cannot participate in all required study activities.You are pregnant.My body has shown a reaction to certain transplant materials.You have a history of allergies, high levels of a specific antibody called IgE, or a high count of a type of white blood cell called eosinophils in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Infusion of γMSCs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.