Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System

Venkatesh, Ponemone; Gupta, Sachin; Sethi, Divya; Suthar, Manish; Sharma, Monika B.; Powell, Richard J.; Harris, Kenneth L.; Jungla, Nungshi; Arambam, Priyadarshini; Kaul, Upendra; Seth, Ashok; Bukhari, Suhail

doi:10.1155/2017/4137626

Cited by 21 publications

(30 citation statements)

References 78 publications

(97 reference statements)

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“…Ponemone et al evaluated the safety and therapeutic effectiveness of intra-muscular injections of a BMC in 17 no-option CLI patients. Their results showed a significant improvement in ABI, TcPO 2 and rest pain with major amputation free survival rate of 70.6% [25]. Similar results were observed in the CLI patients treated with intra-muscular injections of BMC harvested and processed using the rapid point-of-care device, Res-Q™ 60 BMC system.…”

Section: Discussionsupporting

confidence: 65%

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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Section: Discussionsupporting

confidence: 65%

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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“…Our approach of intra-arterial plus intramuscular administration was very different from currently clinically tested intramuscular or intra-arterial approaches [6,7]. We chose the combined approach to bring the cells to the circulation and allow access from the endothelial side for cell to cell interaction and secretion of paracrine factors [19,20].…”

Section: Discussionmentioning

confidence: 99%

“…The different properties of the cell mixture of bone marrow versus mesenchymal stromal cells offer opportunities in particular with respect to immunomodulation and/or regeneration [23]. Despite the evolving evidence for clinical effectiveness of autologous bone marrow derived treatment [7], the preparation of bone marrow and the selection of subgroups of cells from bone marrow warrants further studies [4].…”

Section: Discussionmentioning

confidence: 99%

“…A recent meta-analysis could not identify an approach that is clinically established neither with respect to cell type, dose route of application [6]. Mesenchymal stem cells offer a unique combination of anti-inflammatory and regenerative effects whereas endothelial stem cells may directly promote angiogenesis [7]. In animals with subacute ligated femoral arteries, neo-angiogenesis with restoration of the blood flow to the ischemic limb was reported to develop after injection of different kinds of stem cells [8][9][10][11][12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

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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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“…11 Clinical reports of BMC quickly followed in 2009 for application in multiple types of bone defect pathologies. 12 BMC is now used for critical limb ischemia, 13,14 ligament and tendon injuries, 15 bone regeneration, 16 articular cartilage repair, and relief of articular pain.…”

Section: Bone Marrow Concentratementioning

confidence: 99%

Biological Effects of Bone Marrow Concentrate in Knee Pathologies

et al. 2018

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With our aging population desiring to remain active, the incidence and costs associated with managing knee pain from both acute injury and symptomatic knee osteoarthritis continue to dramatically increase. Current treatment methods fall short with respect to their ability to improve the intra-articular environment and restore normal joint homeostasis. With increasing basic science and clinical evidence showing efficacy, cell-based therapies such as bone marrow concentrate (BMC) hold promise as a nonsurgical joint preserving treatment approach. BMC has inherent advantages over other treatments commonly used for various knee pathologies because it is a point-of-care orthobiologic product that uniquely and simultaneously delivers growth factors, anti-inflammatory proteins, and mesenchymal stem cells. There is increasing evidence for the use of BMC for repair of focal cartilage defects and for the treatment of generalized knee pain. However, continued high-quality studies are necessary for the clinical utility of BMC to be critically assessed with particular attention paid to appropriate patient selection, standardized aspiration, and processing and reporting of both functional and imaging-based outcomes.

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Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System

Cited by 21 publications

References 78 publications

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

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

Biological Effects of Bone Marrow Concentrate in Knee Pathologies

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