Trial reportStem cell research & therapy2025
Salvage treatment of steroid-refractory acute GVHD with the off-the-shelf product of human umbilical cord mesenchymal stromal cells: a multicenter, open label, phase Ib/IIa trial.
Trial report in Stem cell research & therapy, 2025. 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
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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.
- 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.Stem cell research & therapy · 2026Trial
- Stem Cell Therapy for Inflammatory Diseases: Progress, Challenges, and Future Directions.MedComm · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAcute graft-versus-host disease (aGVHD) is a life-threatening complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), particularly if treatment is refractory. Mesenchymal stromal cells (MSCs) have demonstrated promising therapeutic effects in aGVHD, due to their well-described immunomodulatory properties. Based on the importance of maternal-fetal interface immune tolerance, the umbilical cord may provide a superior tissue source of MSC. This study aimed to investigate the safety and efficacy of human umbilical cord derived MSCs (hUC-MSCs) delivered as salvage therapy for steroid-refractory (SR)-aGVHD.
methodsThis phase Ib/IIa, multicenter, open-label clinical trial of a third-party, off-the-shelf preparation of hUC-MSCs enrolled grades II to IV SR-aGVHD patients. This trial consist of 2 parts: a phase Ib dose escalation part using a standard 3 + 3 design, which planed twice weekly i.v. infusions of hUC-MSCs, at 0.5 × 10
resultsThe study enrolled 25 patients with SR-aGVHD who received different doses of hUC-MSCs treatment. Safety analysis showed that no dose-limiting toxicity was observed in all dose groups. An ORR of 80.0% was achieved by day 28, with a complete response rate of 40.0% and a partial response rate of 40.0%. The incidence, severity, and type of adverse events (AEs) were similar across different dose groups, showing no obvious correlation with dose. The RP2D was determined to be 1.0 × 10
conclusionsThe remarkable efficacy and favorable safety profile of hUC-MSCs offer a promising salvage therapy for patients with severe SR-aGVHD.
trial registrationCTR20221330. Registered 06 June 2022, http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml .
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