Efficacy of Autologous Bone Marrow Mononuclear Cell Therapy in Patients with Peripheral Arterial Disease

Wang, Zheng-Xu; Li, Duo; Cao, Jinglin; Liu, Yi-Shan; Wang, Min; Zhang, Xiaoyan; Li, Junli; Wang, Haibo; Liu, Jinlong; Xu, Beilei

doi:10.5551/jat.23374

Cited by 37 publications

(38 citation statements)

References 37 publications

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“…The administration of BM‐MNCs, PB‐MNCs and BM‐MSCs in diabetic CLI patients has resulted in significant improvements in limb perfusion and ulcer healing rates, reductions in amputation rates, and angiographic analysis has demonstrated significant new vessel and collateral circulation formation . These results are consistent with those of meta‐analyses of studies in CLI patients where diabetic patients comprised a significant percentage . Although results so far seem promising, large placebo‐controlled RCT are still needed.…”

Section: Peripheral Artery Disease In the Diabetic Footmentioning

confidence: 99%

The diabetic foot in 2015: an overview

Markakis

Bowling

Boulton

2016

Diabetes Metabolism Res

103

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In 2015, it can be said that the diabetic foot is no longer the Cinderella of diabetic complications. Thirty years ago there was little evidence-based research taking place on the diabetic foot, and there were no international meetings addressing this topic. Since then, the biennial Malvern Diabetic Foot meetings started in 1986, the American Diabetes Association founded their Foot Council in 1987, and the European Association for the Study of Diabetes established a Foot Study Group in 1998. The first International Symposium on the Diabetic Foot in The Netherlands was convened in 1991, and this was soon followed by the establishment of the International Working Group on the Diabetic Foot that has produced useful guidelines in several areas of investigation and the management of diabetic foot problems. There has been an exponential rise in publications on diabetic foot problems in high impact factor journals, and a comprehensive evidence-base now exists for many areas of treatment. Despite the extensive evidence available, it, unfortunately, remains difficult to demonstrate that most types of education are efficient in reducing the incidence of foot ulcers. However, there is evidence that education as part of a multi-disciplinary approach to diabetic foot ulceration plays a pivotal role in incidence reduction. With respect to treatment, strong evidence exists that offloading is the best modality for healing plantar neuropathic foot ulcers, and there is also evidence from two randomized controlled trials to support the use of negative-pressure wound therapy in complex post-surgical diabetic foot wounds. Hyperbaric oxygen therapy exhibits the same evidence level and strength of recommendation. International guidelines exist on the management of infection in the diabetic foot. Many randomized trials have been performed, and these have shown that the agents studied generally produced comparable results, with the exception of one study in which tigecycline was shown to be clinically inferior to ertapenem ± vancomycin. Similarly, there are numerous types of wound dressings that might be used in treatment and which have shown efficacy, but no single type (or brand) has shown superiority over others. Peripheral artery disease is another major contributory factor in the development of ulceration, and its presence is a strong predictor of non-healing and amputation. Despite the proliferation of endovascular procedures in addition to open revascularization, many patients continue to suffer from severely impaired perfusion and exhaust all treatment options. Finally, the question of the true aetiopathogenesis of Charcot neuroarthropathy remains enigmatic, although much work is currently being undertaken in this area. In this area, it is most important to remember that a clinically uninfected, warm, insensate foot in a diabetic patient should be considered as a Charcot foot until proven otherwise, and, as such, treated with offloading, preferably in a cast.

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Section: Peripheral Artery Disease In the Diabetic Footmentioning

confidence: 99%

The diabetic foot in 2015: an overview

Markakis

Bowling

Boulton

2016

Diabetes Metabolism Res

103

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“…Benoit et al (2011), evaluated randomized controlled trials involving bone marrow derived stem and progenitor cells (n=295) and found that the amputation rates between the control arms and treatment arms was statistically significant (25.4% vs.14.8% p=0.02) demonstrating that bone marrow derived cells do improve outcomes in CLI patients [23]. Furthermore, Wang et al analysed 31 published Randomized Controlled Trials (RCTs) and non-RCTs, having a total of 1,214 patients, and advantageous effects of autologous bone-marrow cell therapy was reported, where majority of severe adverse events (SAEs) were associated with hospitalization for disease process-related complications and not related to cell therapy [24]. Ponemone et al evaluated the safety and therapeutic effectiveness of intra-muscular injections of a BMC in 17 no-option CLI patients.…”

Section: Discussionmentioning

confidence: 99%

valuation of Safety and Preliminary Effectiveness of Point-of-Care Cell Processing System: An Observational Study

Gupta¹,

Suthar²,

Sethi³

et al. 2018

Stem Cells Regen Med

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The potential of cell therapy in treating incurable and irreversible diseases has been proven to be safe and feasible with varying degrees of success in medical fraternity. In the past decade, there has been a steady increase in the development of advanced point-of-care cell processing technologies and intra-operative procedures that integrate autologous cell-based therapy with conventional surgical procedure in a single sitting, have emerged as an exciting approach in regenerative medicine and cell therapy field. Point-of-care (POC) cell processing devices are automatic, closed systems that allow rapid processing of whole tissue to the desired cell population at the patient's bedside, at an affordable cost. This observational study evaluates the safety and feasibility of a rapid point-of-care technology, the Res-Q™ 60 system used for processing bone marrow and/or peripheral blood intraoperatively for treating patients with various clinical indications who were administered the cell therapy product either as a standalone treatment or in conjunction with standard-of-care treatment. The data from 254 patients treated using either Bone Marrow Concentrate (BMC) or Platelet Rich Plasma (PRP) produced by Res-Q™ 60 devices was observed and analysed for device performance including cellularity, sterility and safety. The cellular output from Res-Q™ 60 BMC and PRP devices showed a significantly high MNC recovery of 71.35% ± 2.10 (SD) and platelet recovery of 78.3% ± 3.0 (SD), respectively. All the samples were sterile with no bacterial or fungal growth and all the patients tolerated the device output i.e. BMC or PRP well with no related adverse events (SAEs/ AEs). Therefore, the Res-Q™ 60 BMC and PRP devices were found to be safe, feasible and preliminary effective for autologous cellular therapy at the point-of-care.

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“…Stem cell transplantation was established to induce promotion of repair of ischemic tissue partially through angiogenesis which has been shown in models of hind limb ischemia for example [1]. Stem cell therapies differ with respect to the origin of the cells, cell numbers and route of application [2][3][4][5]. Studies were for example performed with unfractionated bone marrow cells, endothelial progenitor cells and/or peripheral blood mononuclear cells which make comparison very difficult [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Different Doses of Human Autologous Adult Bone Marrow Stem Cell Transplantation on Angiogenesis in an Immune Deficient Rat Model with Hind Limb Ischemia

Kramer¹

2019

SRDT

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Background: Stem cell transplantation has been implied to facilitate angiogenesis by direct paracrine effects on signaling pathways. There are many different sources, types, dosages and routes of administration of stem cells under investigation. In this study we tested the concomitant intramuscular and intravenous administration of human mesenchymal and hematopoietic stem cells from bone marrow aspirates in three different dosages in order to establish an optimal dose for angiogenesis. For this purpose a nude T cell deficient rat model with hind limb ischemia was used as a model for angiogenesis which did not warrant immunosuppressive drugs. Methods and Results: Seven days after a surgical occlusion of the A. iliaca externa in the right hind limb, a baseline Digital Subtraction Angiography (DSA) was performed, and animals were intra arterially and intramuscularly injected with low, medium or high concentrations of human mesenchymal stem cells or with a saline 0.9% solution (vehicle). At day 35, DSA was repeated, and the images of both registrations were compared between the different concentration groups and the vehicle group. DSA clearly demonstrated the presence of occlusions, resulting in moderate to severe ischemia 7 days after ligation. Comparing Mean Gray Values at day 35 DSA versus day 7 DSA, the difference did show a natural decrease in the Vehicle-treated group, whereas

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Efficacy of Autologous Bone Marrow Mononuclear Cell Therapy in Patients with Peripheral Arterial Disease

Cited by 37 publications

References 37 publications

The diabetic foot in 2015: an overview

The diabetic foot in 2015: an overview

valuation of Safety and Preliminary Effectiveness of Point-of-Care Cell Processing System: An Observational Study

Efficacy of Different Doses of Human Autologous Adult Bone Marrow Stem Cell Transplantation on Angiogenesis in an Immune Deficient Rat Model with Hind Limb Ischemia

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