Actively Recruiting
Addition of Cord Blood Tissue-Derived Mesenchymal Stromal Cells to Ruxolitinib for the Treatment of Steroid-Refractory Acute Graft Versus Host Disease
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
24
Participants Needed
1
Research Sites
580 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This early phase I trial is to find out the effect of adding cord blood tissue-derived mesenchymal stromal cells (cb-MSCs) to ruxolitinib in treating patients with acute graft versus host disease that does not respond to steroid therapy (steroid-refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. cb-MSCs are a type of tissue helper cell that can be removed from donated umbilical cord blood tissue and grown into many different cell types that can be used to treat cancer and other disease, such as graft versus host disease. This trial aims to learn if adding cb-MSCs to ruxolitinib may help control steroid-refractory acute graft versus host disease.
CONDITIONS
Official Title
Addition of Cord Blood Tissue-Derived Mesenchymal Stromal Cells to Ruxolitinib for the Treatment of Steroid-Refractory Acute Graft Versus Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants between the ages of 12 years and 80 years (inclusive)
- Steroid refractory grades II-IV acute GVHD of the lower GI tract or liver after allogeneic HCT or donor lymphocyte infusion
- No improvement after methylprednisolone at ≥ 2.0 mg/kg/day for at least 7 days, or progressive symptoms after 3 days, or flare while on systemic steroids
- Biopsy suggesting GVHD (repeat biopsy not required for enrollment)
- Karnofsky/Lansky Performance score of at least 30 at study entry
- Women of childbearing potential must be non-pregnant, not breastfeeding, and use adequate contraception
- Male patients must use adequate contraception
- Ability to provide written informed consent (or assent if appropriate)
You will not qualify if you...
- De novo chronic GVHD
- Isolated acute GVHD of the skin
- Secondary systemic therapy for acute GVHD with ruxolitinib started more than 96 hours before study therapy
- Primary treatment with agents other than alpha-1 antitrypsin, glucocorticoids, or ruxolitinib
- Uncontrolled infections defined by signs of progression such as hemodynamic instability, new symptoms, worsening signs or imaging
- Cognitive impairments or serious unstable medical or psychiatric conditions affecting safety or consent
- Significant supplemental oxygen need (>6 L by nasal cannula)
- Known allergy to bovine or porcine products
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Partow Kebriaei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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