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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

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 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: 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.

Do I qualify?Apply below to find out