Trial reportStem cell research & therapy2026
Mesenchymal stromal cells as add-on therapy to anti-CD25 antibodies for treating gastrointestinal-involved steroid-refractory acute graft-versus-host disease: a multicenter, single-arm, pivotal clinical trial.
Trial report in Stem cell research & therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundSteroid-refractory acute graft-versus-host disease (SR-aGVHD) is the predominant cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT), with gastrointestinal involvement (SR-GI-aGVHD) remaining a key obstacle. We conducted a multicenter, single-arm, pivotal trial to assess the efficacy and safety of hUC-MSC PLEB001, a human umbilical cord-derived mesenchymal stromal cells (MSCs) product, plus anti-CD25 monoclonal antibody as second-line therapy for SR-GI-aGVHD.
methodsEligible patients with grade II or higher SR-GI-aGVHD received hUC-MSC PLEB001 with protocol-defined anti-CD25 monoclonal antibody therapy. hUC-MSC PLEB001 was infused at a dose of 10
resultsFifty-four patients (median age 43, range 14-68) were enrolled. The number of Grade II-IV SR-aGVHD patients was 21, 16, 17, respectively. Thirty-seven patients were GI-involved only, 15 patients were GI and skin involved, and 2 patients were GI and liver involved. The ORR at day 28 was 63.0% (95% CI 48.7%, 75.7%), with a CR rate of 55.6% (41.4%, 69.1%). The 28-day durable complete response rate (DCR) was 51.9% (37.8%, 65.7%). The ORR and CR rate at day 56 was 51.9% (37.8%, 65.7%) and 50.0% (36.1%, 63.9%), respectively. The overall survival (OS) for full analysis set (FAS) at day 28, 56, 100, 360 for the entire cohort were 94.4% (83.8%, 98.2%), 88.9% (76.9%, 94.9%), 79.6% (66.2%, 88.2%), 65.8% (51.1%, 77.0%) respectively. Treatment was well tolerated, and no infusion-related toxicity or treatment-related serious adverse events were observed.
conclusionsIn this multicenter single-arm study, hUC-MSC PLEB001 plus anti-CD25 monoclonal antibody therapy was associated with clinically meaningful response rates and an acceptable safety profile in patients with SR-GI-aGVHD. These findings support further evaluation of MSC-based approaches within multimodal treatment algorithms for this challenging condition.
trial registrationRegistry: Chinese Clinical Trial Registry, TRN: ChiCTR2300073965, Registration date: 2023-07-26 (retrospectively registered).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.