Cord blood cells join forces with drug to fight transplant complication
NCT ID NCT04744116
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This early study tests whether adding special cells from donated umbilical cord blood (called mesenchymal stromal cells) to the drug ruxolitinib can help control severe graft-versus-host disease (GVHD) that hasn't improved with steroids. GVHD is a serious complication where donor immune cells attack the patient's body after a stem cell transplant. The trial will enroll 24 people aged 12 to 80 and compare the combination therapy against ruxolitinib alone, looking at response rates and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cord blood tissue-derived mesenchymal stromal cells (cb-MSCs) combined with ruxolitinib
- What this could lead to
- If it works, this could point toward a better treatment for severe graft-versus-host disease that doesn't respond to steroids.
- What could go wrong
- This is a very early, small pilot study with only 24 people, so results may not apply widely. There is also a risk of side effects from the cell infusion or the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- 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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12 to 80 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants between the ages of 12 years and 80 years (inclusive). 2. Steroid refractory grades II-IV acute GVHD of the Lower GI tract or Liver (including those developing these manifestations after previous acute GVHD of skin) secondary to allogeneic HCT or donor lymphocyte infusion. (Grading, see Appendix I) GVHD with: No improvement after treatment with methylprednisolone at ≥ 2.0 mg/kg/day or equivalent for minimum 7 days, or progressive symptoms after minimum 3 days, or a flare in acute GVHD while on systemic steroids. Participants must have had a biopsy that suggests GVHD; a repeat biopsy to enroll on the study is not necessary. 3. Karnofsky/Lansky Performance score of at least 30 at the time of study entry. 4. Participants who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception 5. Participants (or legal representative where appropriate) must be capable of providing written informed consent, and assent if indicated. Exclusion Criteria: 1. De novo chronic GVHD 2. Isolated acute GVHD of skin 3. Secondary systemic therapy for acute GVHD ruxolitinib greater than 96 hours before initiation of therapy. 4. Primary treatment with agents other than alpha-1 antitrypsin (AAT) glucocorticoids and ruxolitinib. 5. Participants with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 6. Adult and pediatric patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures. 7. Participants with significant supplemental oxygen requirement defined as \>6 L oxygen by nasal cannula. 8. Participants with known allergy to bovine or porcine products.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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