Observational studyCardiovascular diabetology2022
Results of a prospective observational study of autologous peripheral blood mononuclear cell therapy for no-option critical limb-threatening ischemia and severe diabetic foot ulcers.
Observational study in Cardiovascular diabetology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Autologous cell therapy for ischemic diabetic foot: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome.Acta diabetologica · 2025Pooled it
- Cutaneous endothelial cells and their roles in wound healing.JID innovations : skin science from molecules to population health · 2026Review
- Autologous Cell Therapy for Chronic Limb Threatening Ischemia: Towards Personalized Medicine.Angiology · 2026Review
- Long-term outcomes of autologous cell therapy in patients with ischaemic diabetic foot ulcers and no-option chronic limb threatening ischaemia.Acta diabetologica · 2026Observational
- Predictive factors of major amputation in patients with diabetic foot ulcers treated by peripheral blood mononuclear cells.Acta diabetologica · 2025Article
- Efficacy of autologous cell therapy on limb salvage in patients with chronic limb-threatening ischemia: 16-year single-center experience.Stem cell research & therapy · 2025Article
- Effectiveness of autologous mononuclear cells as adjuvant therapy in patients with ischaemic diabetic foot ulcers receiving indirect lower limb revascularization.Acta diabetologica · 2025Observational
- Peripheral Arterial Disease in Diabetic Foot: One Disease with Multiple Patterns.Journal of clinical medicine · 2025Review
- Emerging Strategies for Revascularization: Use of Cell-Derived Extracellular Vesicles and Artificial Nanovesicles in Critical Limb Ischemia.Bioengineering (Basel, Switzerland) · 2025Review
- The Immune-Centric Revolution Translated into Clinical Application: Peripheral Blood Mononuclear Cell (PBMNC) Therapy in Diabetic Patients with No-Option Critical Limb-Threatening Ischemia (NO-CLTI)-Rationale and Meta-Analysis of Observational Studies.Journal of clinical medicine · 2024Review
- The Use of Autologous Cell Therapy in Diabetic Patients with Chronic Limb-Threatening Ischemia.International journal of molecular sciences · 2024Review
- [The application of cell products for the treatment of critical limb ischemia in patients with diabetes mellitus: a review of the literature].Problemy endokrinologii · 2024Review
- One-Year Analysis of Autologous Peripheral Blood Mononuclear Cells as Adjuvant Therapy in Treatment of Diabetic Revascularizable Patients Affected by Chronic Limb-Threatening Ischemia: Real-World Data from Italian Registry ROTARI.Journal of clinical medicine · 2024Article
- Successful wound healing by autologous peripheral blood mononuclear cell therapy in a diabetic patient on hemodialysis with no-option critical limb ischemia: a case report.Journal of nephrology · 2024Article
- Cell Therapy of Severe Ischemia in People with Diabetic Foot Ulcers-Do We Have Enough Evidence?Molecular diagnosis & therapy · 2023Article
- Peripheral Blood Mononuclear Cells: A New Frontier in the Management of Patients with Diabetes and No-Option Critical Limb Ischaemia.Journal of clinical medicine · 2023Article
- The Sweet Side of HIPK2.Cancers · 2023Review
- HIPK2 in Angiogenesis: A Promising Biomarker in Cancer Progression and in Angiogenic Diseases.Cancers · 2023Review
- Macromolecular Crowding Supports the Generation of Basal Membrane-Rich Pericyte-Based Cell Sheets Useful for Cell Therapy of Diabetic Wounds.Cell transplantationArticle
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCell therapy with autologous peripheral blood mononuclear cells (PB-MNCs) may help restore limb perfusion in patients with diabetes mellitus and critical limb-threatening ischemia (CLTI) deemed not eligible for revascularization procedures and consequently at risk for major amputation (no-option). Fundamental is to establish its clinical value and to identify candidates with a greater benefit over time. Assessing the frequency of PB circulating angiogenic cells and extracellular vesicles (EVs) may help in guiding candidate selection.
methodsWe conducted a prospective, non-controlled, observational study on no-option CLTI diabetic patients that underwent intramuscular PB-MNCs therapy, which consisted of more cell treatments repeated a maximum of three times. The primary endpoint was amputation rate at 1 year following the first treatment with PB-MNCs. We evaluated ulcer healing, walking capability, and mortality during the follow-up period. We assessed angiogenic cells and EVs at baseline and after each cell treatment, according to primary outcome and tissue perfusion at the last treatment [measured as transcutaneous oxygen pressure (TcPO
results50 patients were consecutively enrolled and the primary endpoint was 16%. TcPO
conclusionsIn no-option CLTI diabetic patients, PB-MNCs therapy led to an improvement in tissue perfusion, a high rate of healing, and back-to-walk. Coupling circulating cellular markers of angiogenesis could help in the identification of patients with a better clinical benefit over time.
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