Cord blood stem cells aim to tame transplant complication
NCT ID NCT03158896
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested whether stem cells from donated umbilical cords are safe for people with a serious condition called acute graft versus host disease (aGVHD), which can happen after a bone marrow transplant. Twenty-four adults received one of two doses of these stem cells. The main goal was to see if the treatment caused serious side effects, and researchers also looked for signs that it helped control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord stem cells (Wharton's jelly mesenchymal stem cells)
- What this could lead to
- If this works, it could point toward a new treatment option for a serious complication of bone marrow transplants, helping control the immune attack on the body.
- What could go wrong
- This is a very early, small phase 1 trial with only 24 people, so it is mainly checking safety, not effectiveness. The stem cells may not work, and there are risks of side effects from the infusion.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Kansas University Cancer Center
Kansas City, Kansas, 66160, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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