Your session is about to expire
← Back to Search
Mesenchymal Stem Cells
Umbilical Cord Stem Cells for Graft-versus-Host Disease
Phase 1
Recruiting
Led By Joseph McGuirk, DO
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if two different doses of stem cells from umbilical cords can help people with aGVHD. The first 5 people will get a lower dose, and if there are no serious problems, the next 5 will get a higher dose.
Who is the study for?
Adults aged 18-75 with acute Graft versus Host Disease after an allogenic transplant at Kansas University Cancer Center. They must use two forms of contraception if of childbearing potential and cannot have used other investigational agents for aGVHD within the last 30 days. Those with medical or psychiatric conditions that could affect trial participation are excluded.
What is being tested?
The trial is testing two doses of Wharton's jelly mesenchymal stem cells (MSCTC-0010) for treating aGVHD. The first group receives a lower dose, and if safe, the next group gets a higher dose. Safety is monitored by looking out for serious adverse events over 42 days.
What are the potential side effects?
While specific side effects aren't listed, participants will be closely monitored for any serious adverse events related to the treatment during the initial phase before proceeding to higher doses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
proportion of participants who have a TRSAE after infusion of MSCTC 0010
Secondary study objectives
Occurrence of Formation of ectopic tissue foci at day 90
Occurrence of addition of escalated immunosuppressive therapy by day 90
Proportion of participants who achieve a complete response (CR) of aGVHD by study day 42
+1 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: MSCTC-0010 Dose EscalationExperimental Treatment1 Intervention
Cohort 1: First 5 participants will receive a lower dose of cord-blood derived Wharton's jelly mesenchymal stem cells (MSCTC-0010) and they will be observed for 42 days after the dose for treatment-related serious adverse events (TRSAE) and response.
Cohort 2: Second 5 participants will receive an increased dose of MSCTC-0010 and will be observed for 42 days after the dose for TRSAE and response.
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
517 Previous Clinical Trials
177,288 Total Patients Enrolled
Joseph McGuirk, DOPrincipal InvestigatorThe University of Kansas - Cancer Center