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MSC Therapy for Asthma
Study Summary
This trial is designed to assess the safety and determine the maximal tolerated dose (MTD) of two different types of stem cells, allogenic cord tissue derived MSCs (cMSCs) and allogeneic, interferon-γ primed bone marrow MSCs (γMSCs). Each stratum is designed to independently accrue 3 children at a dose level 1 of 2x106 cells/kg and 6 children at dose level 2 of 10x106 cells/kg, resulting in 9 children in each stratum. The primary objectives are to determine the safety and toxicity of allogenic cord tissue derived MSCs and allogeneic
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Infusion of γMSCs
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any further opportunities to participate in this medical research?
"According to information on clinicaltrials.gov, this experiment is actively recruiting participants and was initially shared on March 16th 2022 before being amended July 21st of the same year."
To what purposes are Interferon gamma-primed mesenchymal stromal cells (MSCs) typically applied?
"Interferon gamma-primed mesenchymal stromal cells (MSCs) is a commonly utilized intervention for treating ulcerative colitis, while it can also be applied to address varicella-zoster virus acute retinal necrosis, cerebral issues and iritis."
What is the limit of participants enrolling in this clinical investigation?
"Affirmative. Per the details provided on clinicaltrials.gov, this medical trial's recruitment process is ongoing since its initiation on March 16th 2022. Currently 12 patients are being recruited from one single site and was most recently updated July 21st 2022."
What are the main goals of this research project?
"As the main measure of efficacy, this trial will assess Adverse Events and Severe AEs following infusion over a period of 7 days (study day 14). Secondary objectives involve assessing Circulating Inflammatory Cells via Flow Cytometry & AbSeq Analysis, Upper Airway Inflammation through small molecule constituents in Exhaled Breath Condensate, as well as gauging Biophysical Characteristics of γMSCs at MC3M."
Is it possible to participate in this clinical exploration?
"The requirements to join this study are specific. Candidates aged between 18 and 30 who were diagnosed with asthma in their youth, exhibit signs of atopy (elevated IgE levels or blood eosinophil counts) and have moderate-to-severe persistent asthma according to the National Asthma Education and Prevention Program Expert Panel Report-4 can apply for inclusion into the trial. A total of 12 such patients will be accepted."
What implications do Interferon gamma-primed mesenchymal stromal cells (MSCs) pose to patient safety?
"Our assessment at Power gauged the safety of Interferon gamma-primed mesenchymal stromal cells (MSCs) to be a 1 due to this being an exploratory phase with limited evidence in terms of efficacy and safety."
Have Interferon gamma-primed mesenchymal stromal cells (MSCs) been employed in other medical trials?
"At present, 384 clinical trials are being conducted on Interferon gamma-primed mesenchymal stromal cells (MSCs), with 95 of those in the third phase. Most notably, there is a concentration of studies centred around Duarte, California; yet globally 16600 medical facilities are running research into Interferon gamma-primed mesenchymal stromal cells (MSCs)."
Is the enrollment criteria for this trial age-specific or open to persons over thirty?
"The eligibility requirements of this trial stipulate that only individuals aged 18 to 30 can enroll. For those younger than 18, there are 180 clinical trials available and 522 for seniors over the age of 65."
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