Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease

Completed · Phase 1

Conditions studied: Acute Graft Versus Host Disease

In brief

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.

Key facts

Study ID

NCT03158896

Run by

University of Kansas Medical Center

People needed

24

Starts

2018-07-09

Expected to finish

2025-12-08

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: ≥ 18 years of age and ≤ 75 years of age.
• Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.
• A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; OR
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment.
• NOTE: Acceptable forms of birth control are listed below:
• One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS
• Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T).
• Participant must have de novo HR or steroid refractory, Grade II-IV aGVHD as defined in Appendix 1. NOTE: Biopsy at screening only for evaluation of aGVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.
• Participant must have received an allogenic transplant at Kansas University Cancer Center/University of Kansas Medical Center (KUCC / KUMC).

You may not qualify if…

• Participants may not have received any other investigational agent used to treat acute GVHD for 30 days prior to enrollment.
• Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant.

Where it is running

• Kansas University Cancer Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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