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

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · May 16, 2017

Keywords

ClinConnect Summary

This clinical trial is testing a treatment for a condition called acute Graft Versus Host Disease (aGVHD), which can happen after a stem cell transplant. The researchers are looking at how safe and effective two different doses of special stem cells—taken from umbilical cords—are for treating this condition. Initially, the first five participants will receive a lower dose of these stem cells. If they do not experience any serious side effects after 42 days, the next group of five will receive a higher dose.

To participate in this study, you need to be between 18 and 75 years old and have been diagnosed with a specific type of aGVHD that hasn’t responded well to standard treatments. You also need to have received a stem cell transplant at the Kansas University Cancer Center. Participants will need to follow certain guidelines, like using effective birth control methods during the study. If you join, you will be closely monitored to ensure your safety while receiving the stem cell treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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).
• Exclusion Criteria:
• • 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.