Trial reportStem cells translational medicine2012
A phase II trial of autologous transplantation of bone marrow stem cells for critical limb ischemia: results of the Naples and Pietra Ligure Evaluation of Stem Cells study.
Trial report in Stem cells translational medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease.
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 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
- [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
- Function and mechanism of mesenchymal stem cells in the healing of diabetic foot wounds.Frontiers in endocrinology · 2023Review
- Successful Revascularization of Infrapopliteal Chronic Total Occlusions Using the Plantar Arch as a Conduit and Retrograde Pedal Access.Ochsner journal · 2021Article
- Cord Lining Mesenchymal Stem Cells Have a Modest Positive Effect on Angiogenesis in Hindlimb Ischemia.Frontiers in cell and developmental biology · 2020Article
- One-Year Outcomes of Peripheral Endovascular Device Intervention in Critical Limb Ischemia Patients: Sub-Analysis of the LIBERTY 360 Study.Vascular health and risk management · 2020Observational
- Pro-inflammatory cytokines activate hypoxia-inducible factor 3α via epigenetic changes in mesenchymal stromal/stem cells.Scientific reports · 2018Article
- Improving the therapeutic efficacy of mesenchymal stromal cells to restore perfusion in critical limb ischemia through pulsed focused ultrasound.Scientific reports · 2017Article
- A Molecular and Clinical Review of Stem Cell Therapy in Critical Limb Ischemia.Stem cells international · 2017Review
- Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.Stem cells international · 2017Article
- Advances in the Treatment of Ischemic Diseases by Mesenchymal Stem Cells.Stem cells international · 2016Review
- Adipose tissue-derived stem cells as a therapeutic tool for cardiovascular disease.World journal of cardiology · 2015Review
- Intrastriatal transplantation of adult human neural crest-derived stem cells improves functional outcome in parkinsonian rats.Stem cells translational medicine · 2015Article
- Adult Stem Cells and Diseases of Aging.Journal of clinical medicine · 2014Article
- SIRT1 inhibition affects angiogenic properties of human MSCs.BioMed research international · 2014Article
- Prognostic significance of circulating and endothelial progenitor cell markers in type 2 diabetic foot.International journal of vascular medicine · 2014Article
- Intra-arterial allogeneic mesenchymal stem cells for critical limb ischemia are safe and efficacious: report of a phase I study.World journal of surgery · 2013Article
- Article
- Autologous bone marrow cell therapy for peripheral arterial disease.Stem cells and cloning : advances and applications · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Critical limb ischemia (CLI) is a vascular disease affecting lower limbs, which is going to become a demanding challenge because of the aging of the population. Despite advances in endovascular therapies, CLI is associated with high morbidity and mortality. Patients without direct revascularization options have the worst outcomes. To date, 25%-40% of CLI patients are not candidates for surgical or endovascular approaches, ultimately facing the possibility of a major amputation. This study aimed to assess the safety and efficacy of autologous bone marrow (BM) transplantation performed in "no-option" patients, in terms of restoring blood perfusion by collateral flow and limb salvage. A multicenter, prospective, not-controlled phase II study for no-option CLI patients was performed. Patients were subjected to intra-arterial infusion of autologous bone marrow and followed for 12 months after the treatment. Variation of blood perfusion parameters, evaluated by laser Doppler flowmetry or transcutaneous oximetry, was set as the primary endpoint at 12 months after treatment and amputation-free survival as the secondary endpoint. Sixty patients were enrolled and treated with BM transplantation, showing improvement in objective and subjective measures of perfusion. Furthermore, survival analysis demonstrated improved amputation-free survival rates (75.2%) at 12 months after the treatment. This study provides further evidence that autologous bone marrow transplantation is well tolerated by CLI patients without adverse effects, demonstrating trends toward improvement in perfusion and reduced amputation rate, confirming the feasibility and safety of the procedure.
Indexed as
Identifiers
What OpenQuestion holds
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.