Trial reportStem cell research & therapy2022
Novel topical allogeneic bone-marrow-derived mesenchymal stem cell treatment of hard-to-heal diabetic foot ulcers: a proof of concept study.
Trial report in Stem cell research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- The Efficacy of Stem Cells in Wound Healing: A Systematic Review.International journal of molecular sciences · 2024Pooled it
- Current trends in electrospun nanofibers combined with mesenchymal stem cells for diabetic foot ulcer repair and regenerative therapy.iScience · 2026Review
- The progress and challenges of mesenchymal stromal cell-based therapy for diabetes and its complications.Biological research · 2026Review
- FGFR2 is a Crucial Factor for Adipose-Derived Mesenchymal Stem Cells in Promoting Diabetic Foot Ulcer Healing Through Angiogenesis.Journal of cellular and molecular medicine · 2025Article
- Dimethyl sulfoxide in cryopreserved mesenchymal stromal cell therapy products: is there a safety risk to patients?Journal of translational medicine · 2025Review
- Targeting diabetic foot ulcer pathophysiology: altered signaling pathways and 3D scaffold as an emerging treatment strategy.3 Biotech · 2025Review
- Adipose-derived Stem Cells for Treatment of Diabetic Foot Ulcers: A Review.Current stem cell research & therapy · 2025Review
- The Potential of Mesenchymal Stem/Stromal Cells in Diabetic Wounds and Future Directions for Research and Therapy-Is It Time for Use in Everyday Practice?International journal of molecular sciences · 2024Review
- Inflammation-Modulating Biomedical Interventions for Diabetic Wound Healing: An Overview of Preclinical and Clinical Studies.ACS omega · 2024Review
- Current state of stem cell research in non-human primates: an overview.Medical review (2021) · 2023Review
- Progress and expectation of stem cell therapy for diabetic wound healing.World journal of clinical cases · 2023Review
- Mesenchymal stem cell therapy for non-healing diabetic foot ulcer infection: New insight.Frontiers in bioengineering and biotechnology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimThe aim of this study was to investigate safety of treating diabetic foot ulcers with a topically administered mesenchymal stem cell product.
methodIndividuals with diabetes, peripheral neuropathy, toe blood pressure > 39 mmHg and non-infected foot ulcers with duration of four to fifty-two weeks were screened. Participants were treated with a one-time application of a topically applied allogeneic cellular product containing CD362 enriched mesenchymal stem cells suspended in a collagen solution. Participants were subsequently followed for seven months to gather information on adverse event and serious adverse events. RESULTS/DISCUSSION: A total of sixteen individuals were screened, of whom two were included. The included participants incurred a total of seven adverse events and one serious adverse event. Increased exudation from the treated diabetic foot ulcer was observed for both participants and a connection to investigational medicinal product was suspected. The increased exudation was resolved within one week after application of investigational medicinal product, without any further complications. The serious adverse event consisted of a hospital admission due to neurological symptoms, which were assumed to be caused by hypoglycemia, with no suspected correlation to the investigational medicinal product. None of the other observed adverse events were suspected to be associated with the investigational medicinal product.
conclusionThis study presents data from two individuals with a diabetic foot ulcer treated with a novel topical mesenchymal stem cell product. An adverse event observed for both participants was suspected to be associated to the investigational medicinal product, i.e., increased exudation, which was resolved within one week, did not lead to further complications and can easily be remedied by choosing bandages with higher absorption capacity or increasing frequency of bandage changes. This study lays the groundwork for further large scale randomized clinical studies.
trial registrationEudraCT number 2015-005580-16. Registered 12/06-2018.
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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.