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NCT03158896 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease
A Phase 1 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03158896: Completed Phase 1 study, sponsored by University of Kansas Medical Center.
NCT03158896 is a Phase 1 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03158896, a Phase 1 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study evaluates the safety and effectiveness of two different doses of umbilical cord derived, ex-vivo cultured and expanded Wharton's jelly mesenchymal stem cells (MSCTC-0010) in the treatment of acute Graft versus Host Disease (aGVHD). The first 5 participants enrolled in the study will receive a lower dose of MSCTC-0010. If none of the first 5 participants have treatment-related serious adverse events (TRSAEs) for 42 days, then the next 5 participants will receive a slightly higher dose of MSCTC-0010.
Primary Outcome
TRSAE is defined as a serious adverse event (SAE) that has a "probable" or "definite" relation to the MSCTC-0010 infusion. This study will use the descriptions and grading scales from Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) for hematologic and non-hematologic toxicities.
Interventions
- BIOLOGICAL MSCTC-0010 Dose Escalation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2025-12-08 |
| Phase | Phase 1 |
What the finished NCT03158896 record still lists
NCT03158896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which MSCTC-0010 Dose Escalation is the first listed.
NCT03158896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03158896 about?
NCT03158896 is a clinical study titled "Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease". This study evaluates the safety and effectiveness of two different doses of umbilical cord derived, ex-vivo cultured and expanded Wharton's jelly mesenchymal stem cells (MSCTC-0010) in the treatment of acute Graft versus Host Disease (aGVHD). The first 5 participants enrolled in the study will recei...
What is the current status of trial NCT03158896?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-07-09. Estimated completion is 2025-12-08.
What interventions are being tested in trial NCT03158896?
The interventions under investigation include: MSCTC-0010 Dose Escalation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03158896?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03158896's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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