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
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: 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)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Infusion of γMSCs
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: Interferon gamma-primed mesenchymal stromal cells (MSCs) · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 30 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor