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Mesenchymal Stem Cells

MSCTC-0010 Dose Escalation 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
Age: ≥ 18 years of age and ≤ 75 years of age.
Has not undergone a hysterectomy or bilateral oophorectomy; OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have not had my uterus or both ovaries removed.
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I will not donate sperm during the study and for 3 months after.
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I use two forms of birth control, including a barrier method and spermicide.
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I have a certain type of acute graft-versus-host disease that hasn't responded well to initial treatments.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
proportion of participants who have a TRSAE after infusion of MSCTC 0010
Secondary outcome measures
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

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
459 Previous Clinical Trials
169,094 Total Patients Enrolled
Joseph McGuirk, DOPrincipal InvestigatorThe University of Kansas - Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the elderly population eligible for participation within this research endeavor?

"According to the trial's criteria, individuals between 18 and 75 are eligible for enrolment. There are 65 trials taking place for minors, and 147 studies being conducted on seniors over the age of 65."

Answered by AI

Has the MSCTC-0010 Dose Escalation regimen been cleared by federal regulators?

"Due to the preliminary nature of the data, MSCTC-0010 Dose Escalation received a safety score of 1. This is because this phase one trial has limited clinical evidence that supports both its efficacy and risk profile."

Answered by AI

Are there any restrictions on who may participate in this clinical experiment?

"This medical trial is recruiting 10 people diagnosed with GVHD within a specified age range (18-75). In order to meet the criteria, they must be using double contraception, have de novo HR or steroid refractory Grade II-IV aGVHD as outlined in Appendix 1 – though biopsy at screening is optional. Moreover, participants should have received an allogenic transplant from Kansas University Cancer Center/University of Kansas Medical Centre and cannot naturally postmenopausal for 12 consecutive months nor donate sperm while partaking in this study and 90 days after completing their treatment."

Answered by AI

What is the current sample size of this research?

"Affirmative. According to clinicaltrials.gov, this research endeavour first went public on July 9th 2018 and has since been altered as recently as June 6th 2022; presently the trial is recruiting a total of 10 participants from one site."

Answered by AI

Is the research currently in search of participants?

"According to the clinicaltrials.gov entry, this trial is actively enrolling participants as of June 6th 2022 and was first posted on July 9th 2018."

Answered by AI
~2 spots leftby Aug 2025