ArticleStem cell reviews and reports2020
A Phase I Study to Evaluate Two Doses of Wharton's Jelly-Derived Mesenchymal Stromal Cells for the Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease.
Article in Stem cell reviews and reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
29 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- Current status of clinical trials assessing mesenchymal stem cell therapy for graft versus host disease: a systematic review.Stem cell research & therapy · 2022Pooled it
- Trial
- Human umbilical cord-derived mesenchymal stromal cells for the treatment of steroid refractory grades III-IV acute graft-versus-host disease with long-term follow-up.Frontiers in immunology · 2024Trial
- [Mechanisms and clinical research progress of mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Review
- Stem Cell Therapy for Inflammatory Diseases: Progress, Challenges, and Future Directions.MedComm · 2026Review
- A phase 1b study on the safety of Wharton's jelly mesenchymal stromal cells in the treatment of acute graft-versus-host disease.Cytotherapy · 2026Article
- Therapeutic impact of mesenchymal stem cells on idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell transplantation.International journal of hematology · 2025Article
- Remestemcel-L-rknd (Ryoncil): the first approved cellular therapy for steroid-refractory acute GVHD.Blood · 2025Review
- Large-scale manufacturing of immunosuppressive extracellular vesicles for human clinical trials.Cytotherapy · 2025Article
- Mesenchymal stem cells in treating human diseases: molecular mechanisms and clinical studies.Signal transduction and targeted therapy · 2025Review
- Extracellular Vesicles for Clinical Diagnostics: From Bulk Measurements to Single-Vesicle Analysis.ACS nano · 2025Review
- Mesenchymal Stromal Cells and Graft-versus-Host Disease: Preclinical and Clinical Studies.Stem cell reviews and reports · 2025Review
- Comparison of the chondrogenic potential of eBMSCs and eUCMSCs in response to selected peptides and compounds.BMC veterinary research · 2025Article
- Umbilical Cord Matrix (Wharton Jelly) Mesenchymal Stem Cells in Next-generation Myocardial Repair and Regeneration: Mechanisms and Pre-clinical Evidence.Current cardiology reviews · 2025Review
- Article
- Large Scale Manufacturing of Wharton's Jelly Mesenchymal Stromal Cells for Clinical Use.Stem cells international · 2025Article
- Umbilical cord blood and cord tissue banking as somatic stem cell resources to support medical cell modalities.Inflammation and regeneration · 2023Review
- The efficiency of human umbilical cord mesenchymal stem cells as a salvage treatment for steroid-refractory acute graft-versus-host disease.Clinical and experimental medicine · 2023Article
- Wharton's jelly mesenchymal stem cells: a concise review of their secretome and prospective clinical applications.Frontiers in cell and developmental biology · 2023Review
- Umbilical cord blood derived cellular therapy: advances in clinical development.Frontiers in oncology · 2023Review
Corrections and comments
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Authors and funding
15 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundBecause of their well-described immunosuppressive properties, allogeneic adult human mesenchymal stromal cells (MSC) derived from bone marrow have demonstrated safety and efficacy in steroid refractory acute graft versus host disease (SR aGVHD). Clinical trials have resulted in variable success and an optimal source of MSC has yet to be defined. Based on the importance of maternal-fetal interface immune tolerance, extraembryonic fetal tissues, such as the umbilical cord, may provide an superior tissue source of MSC to mediate immunomodulation in aGVHD.
methodsA two-dose cohort trial allogeneic Wharton's Jelly-derived mesenchymal stromal cells (WJMSC, referred to as MSCTC-0010, here) were tested in 10 patients with de novo high risk (HR) or SR aGVHD post allogeneic hematopoietic stem cell transplantation (allo-HCT). Following Good Manufacturing Practices isolation, expansion and cryostorage, WJMSC were thawed and administered via intravenous infusions on days 0 and 7 at one of two doses (low dose cohort, 2 × 10
resultsSafety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed. Clinical response was suggested at day 28: the overall response rate (ORR) was 70%, 4 of 10 patients had a complete response (CR) and 3 had a partial response (PR). By study day 90, the addition of escalated immunosuppressive therapy was necessary in 2 of 9 surviving patients. Day 100 and 180 post infusion survival was 90% and 60%, respectively. Serum biomarker REG3α decreased, particularly in the high dose cohort, and with REG3α decrease correlated with clinical response.
conclusionsTreatment of patients with de novo HR or SR aGVHD with low or high dose MSCTC-0010 was safe: the infusion was well-tolerated, and no TRAEs or ectopic tissue formation was observed. A clinical improvement was seen in about 70% patients, with 4 of 10 showing a complete response that may have been attributable to MSCTC-0010 infusions. These observations indicate safety of two different doses of MSCTC-0010, and suggest that the 10 × 10
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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.