Trial reportStem cell research & therapy2016
Characteristics of responders to autologous bone marrow cell therapy for no-option critical limb ischemia.
Trial report in Stem cell research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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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
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Autologous cells derived from different sources and administered using different regimens for 'no-option' critical lower limb ischaemia patients.The Cochrane database of systematic reviews · 2018Pooled it
- Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience.Stem cell research & therapy · 2020Trial
- Exhaustion of the bone marrow progenitor cell reserve is associated with major events in severe limb ischemia.Angiogenesis · 2019Trial
- Predictors of responders to mononuclear stem cell-based therapeutic angiogenesis for no-option critical limb ischemia.Stem cell research & therapy · 2019Trial
- A nature-derived, strong adhesive hydrogel microsphere for wet tissue repair: Multifunctional and clinical potential.Bioactive materials · 2026Article
- Late Bone Marrow Mononuclear Cell Transplantation in Rats with Sciatic Nerve Crush: Analysis of a Potential Therapeutic Time Window.International journal of molecular sciences · 2024Article
- Angiogenic properties and intercellular communication of differentiated porcine endothelial cells in vascular therapy.Scientific reports · 2024Article
- [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
- Modalities to Deliver Cell Therapy for Treatment of Chronic Limb Threatening Ischemia.Advances in wound care · 2024Review
- Article
- Cell Therapy of Vascular and Neuropathic Complications of Diabetes: Can We Avoid Limb Amputation?International journal of molecular sciences · 2023Article
- Cell Therapy of Severe Ischemia in People with Diabetic Foot Ulcers-Do We Have Enough Evidence?Molecular diagnosis & therapy · 2023Article
- Current and Novel Emerging Medical Therapies for Peripheral Artery Disease: A Literature Review.Advanced pharmaceutical bulletin · 2023Review
- Return to work after cell transplantation in patients with angiitis-induced critical limb ischaemia and factors related: a single-centre retrospective cohort study.Stem cell research & therapy · 2022Article
- Comparison of the impact of autologous cell therapy and conservative standard treatment on tissue oxygen supply and course of the diabetic foot in patients with chronic limb-threatening ischemia: A randomized controlled trial.Frontiers in endocrinology · 2022Article
- Review
- Cell Therapy for Critical Limb Ischemia: Advantages, Limitations, and New Perspectives for Treatment of Patients with Critical Diabetic Vasculopathy.Current diabetes reports · 2021Review
- Current Status of Angiogenic Cell Therapy and Related Strategies Applied in Critical Limb Ischemia.International journal of molecular sciences · 2021Review
- Vascular Regeneration in Peripheral Artery Disease.Arteriosclerosis, thrombosis, and vascular biology · 2020Review
- Applicability of Transcutaneous Oxygen Tension Measurement in the Assessment of Chronic Limb-Threatening Ischemia.Angiology · 2020Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe present study investigated factors associated with therapeutic benefits after autologous bone marrow cell (BMC) therapy in patients with "no-option" critical limb ischemia (CLI). METHODS AND
resultsSixty-two patients with advanced CLI (Rutherford category 5 or 6) not eligible for revascularization were randomized to treatment with 40 ml of autologous BMCs (SmartPreP2) by local intramuscular (n = 32) or intra-arterial (n = 30) application. The primary endpoint was limb salvage and wound healing at 12 months. Seven patients (11 %) died during the follow-up from reasons unrelated to stem cell therapy. The BMC product of patients with limb salvage and wound healing (33/55) was characterized by a higher CD34(+) cell count (p = 0.001), as well as a higher number of total bone marrow mononuclear cells (BM-MNCs) (p = 0.032), than that of nonresponders (22/55). Patients with limb salvage and wound healing were younger (p = 0.028), had lower C-reactive protein levels (p = 0.038), and had higher transcutaneous oxygen pressure (tcpO2) (p = 0.003) before cell application than nonresponders. All patients with major tissue loss at baseline (Rutherford 6 stage of CLI, n = 5) showed progression of limb ischemia and required major limb amputation. In the multiple binary logistic regression model, the number of applied CD34(+) cells (p = 0.046) and baseline tcpO2 (p = 0.031) were independent predictors of limb salvage and wound healing. The number of administrated BM-MNCs strongly correlated with decreased peripheral leukocyte count after 6 months in surviving patients with limb salvage (p = 0.0008).
conclusionPatients who benefited from autologous BMC therapy for "no-option" CLI were treated with high doses of CD34(+) cells. The absolute number of applied BM-MNCs correlated with the improvement of inflammation. We hypothesize that the therapeutic benefit of cell therapy for peripheral artery disease is the result of synergistic effects mediated by a mixture of active cells with regenerative potential. Patients at the most advanced stage of CLI do not appear to be suitable candidates for cell therapy.
trial registrationThe study was approved and registered by the ISRCTN registry.
trial registrationISRCTN16096154 . Registered: 26 July 2016.
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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.