Autologous bone marrow mononuclear cell therapy improves symptoms in patients with end-stage peripheral arterial disease and reduces inflammation-associated parameters

Malyar, Nasser; Radtke, Stefan; Malyar, Khalil; Arjumand, Jawed; Horn, Peter A.; Kröger, Knut; Freisinger, Eva; Reinecke, Holger; Giebel, Bernd; Brock, Franz-Eduard

doi:10.1016/j.jcyt.2014.05.001

Cited by 17 publications

(11 citation statements)

References 45 publications

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“…37-39 Thus, we chose to use the multiple-site (n=40) gastrocnemius injection method because it results in a cellular depot in the ischemic tissue. 38 In the present study, 23 patients were treated with ECEPCs and 17 were treated with BM-MNCs, and the absolute number of viable injected EPCPCs and BM-MNCs was comparable to that reported in other studies using the same source of cells and route of administration. 8,32,41, 42 However, it should be noted that the number of recovered CD34 + SC was in the order of 10 6 , compared with 10 9 CD14 + CD34 low cells, in both the BM-MNC and ECEPC suspensions.…”

Section: Comparison Of Instrumental Vascular Tests Between the Ecepc supporting

confidence: 88%

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Liotta

Annunziato

Castellani

et al. 2018

Circ J

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Section: Comparison Of Instrumental Vascular Tests Between the Ecepc supporting

confidence: 88%

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Liotta

Annunziato

Castellani

et al. 2018

Circ J

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“…17 In contrast, others have reported that patients with advanced CLI may not benefit from cell therapy. 18,29,47 This suggests that cell therapy should be evaluated at earlier stages of CLI and as an adjuvant therapy to surgical or endovascular procedures.…”

Section: Discussionmentioning

confidence: 99%

Autologous Bone Marrow Mononuclear Cell Implantation and Its Impact on the Outcome of Patients With Critical Limb Ischemia　― Results of a Randomized, Double-Blind, Placebo-Controlled Trial ―

Pignon

Sevestre²,

Kanagaratnam

et al. 2017

Circ J

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Background: Cell therapy is a therapeutic option for patients presenting with nonrevascularizable critical limb ischemia (CLI). However there is a lack of firm evidence on its efficacy because of the paucity of randomized controlled trials. Methods and Results:The BALI trial was a multicenter, randomized, controlled, double-blind clinical trial that included 38 patients. For all of them, 500 mL of bone marrow were collected for preparation of a BM-MNC product that was implanted in patients assigned to active treatment. For the placebo group, a placebo cell-free product was implanted. Within 6 months after inclusion, major amputations had to be performed in 5 of the 19 placebo-treated patients and in 3 of the 17 BM-MNC-treated patients. According to a classical logistic regression analysis there was no significant difference. However, when using the jackknife analysis, 6 months after inclusion BM-MNC implantation was associated with a lower risk of major amputation (odds ratio (OR): 0.55; 95% confidence interval (CI): 0.52-0.58; P<0.0001) and of occurrence of any event (major or minor amputation, or revascularization) (OR: 0.30; 95% CI: 0.29-0.31; P<0.0001). The secondary endpoints (i.e., pain, ulcers, TcPO2, and ankle-brachial index value) were not statistically different between groups. Conclusions:Our results suggested that cell therapy reduced the risk of major amputation in patients presenting with nonrevascularizable CLI.

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“…Although the studies described above have primarily evaluated the therapeutic effects of intramuscular administration of MNCs from either bone marrow or blood, the potential of intra-arterial MNC delivery is also being explored. 97–99 Intramuscular delivery is hypothesized to result in a transient cell depot directly within the ischemic tissue site to allow both local paracrine activity as well as incorporation of cells into the neovasculature. Intra-arterial delivery is thought to direct stem cells into viable peri-ischemic zones with sufficient oxygen and nutrient content for cell function support.…”

Section: Trials Of Cell-based Therapiesmentioning

confidence: 99%

“…97,103–105 In a randomized study of 27 no-option CLI patients, Van Tongeren et al 98 showed a nonsignificant trend toward lower amputation rates in the intramuscular+intra-arterial group compared with the intramuscular group. Hence, larger studies are need to clarify further the optimal route of therapeutic cell delivery.…”

Section: Trials Of Cell-based Therapiesmentioning

confidence: 99%

Modulating the Vascular Response to Limb Ischemia

Cooke

Losordo

2015

Circulation Research

190

151

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The age-adjusted prevalence of peripheral arterial disease in the US population has been estimated to approach 12%. The clinical consequences of occlusive peripheral arterial disease include pain on walking (claudication), pain at rest, and loss of tissue integrity in the distal limbs; the latter may ultimately lead to amputation of a portion of the lower extremity. Surgical bypass techniques and percutaneous catheter-based interventions may successfully reperfuse the limbs of certain patients with peripheral arterial disease. In many patients, however, the anatomic extent and distribution of arterial occlusion is too severe to permit relief of pain and healing of ischemic ulcers. No effective medical therapy is available for the treatment of such patients, for many of whom amputation represents the only hope for alleviation of symptoms. The ultimate failure of medical treatment and procedural revascularization in significant numbers of patients has led to attempts to develop alternative therapies for ischemic disease. These strategies include administration of angiogenic cytokines, either as recombinant protein or as gene therapy, and more recently, to investigations of stem/progenitor cell therapy. The purpose of this review is to provide an outline of the preclinical basis for angiogenic and stem cell therapies, review the clinical research that has been done, summarize the lessons learned, identify gaps in knowledge, and suggest a course toward successfully addressing an unmet medical need in a large and growing patient population.

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Autologous bone marrow mononuclear cell therapy improves symptoms in patients with end-stage peripheral arterial disease and reduces inflammation-associated parameters

Cited by 17 publications

References 45 publications

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Autologous Bone Marrow Mononuclear Cell Implantation and Its Impact on the Outcome of Patients With Critical Limb Ischemia　― Results of a Randomized, Double-Blind, Placebo-Controlled Trial ―

Modulating the Vascular Response to Limb Ischemia

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Autologous bone marrow mononuclear cell therapy improves symptoms in patients with end-stage peripheral arterial disease and reduces inflammation-associated parameters

Cited by 17 publications

References 45 publications

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia ― The SCELTA Trial ―

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia ― The SCELTA Trial ―

Autologous Bone Marrow Mononuclear Cell Implantation and Its Impact on the Outcome of Patients With Critical Limb Ischemia ― Results of a Randomized, Double-Blind, Placebo-Controlled Trial ―

Modulating the Vascular Response to Limb Ischemia

Contact Info

Product

Resources

About

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia　― The SCELTA Trial ―

Autologous Bone Marrow Mononuclear Cell Implantation and Its Impact on the Outcome of Patients With Critical Limb Ischemia　― Results of a Randomized, Double-Blind, Placebo-Controlled Trial ―