The Aastrom experience

Bartel, Ronnda L.; Cramer, Caryn; Ledford, Kelly J; Longcore, Amy; Parrish, Christopher R.; Stern, Theresa; Watling, Sharon M.; Zeigler, Frank

doi:10.1186/scrt117

Cited by 26 publications

(54 citation statements)

References 19 publications

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“…Основу препарата состав-ляет увеличенная фракция двух ключевых типов монону-клеарных клеток: CD90+ мезенхимальных стволовых кле-ток и макрофагов CD45+ и CD14+ [32][33][34]. На основе экспериментальных работ было обнаружено, что препа-рат ixmyelocel-T обладает мультимодальным механизмом действия, в том числе локальным паракринным эффек-том [35]. Или CD90+, или CD14+ клетки в ixmyelocel-T секретируют в 10 раз больше противовоспалительных цитокинов (интерлейкин-1, интерлейкин-10, макрофа-гальный воспалительный протеин 1-альфа, фактор роста эндотелия сосудов и фактор роста гепатоцитов), чем в популяции МККК.…”

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Cell therapy for dilated cardiomyopathy: State-of-the-art

Safiullina¹,

Uskach²,

Терещенко³

et al. 2017

RHFJ

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Cell therapy for dilated cardiomyopathy: State-of-the-art

Safiullina¹,

Uskach²,

Терещенко³

et al. 2017

RHFJ

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“…Gupta and colleagues describe the use of mesenchymal stem cells for cartilage repair [9], while Donnelly and colleagues describe their experience using human neural stem cells to treat spinal cord injury [10]. In the same issue, Bartel and colleagues describe their efforts to manufacture an autologous differentiated cell product for the treatment of critical limb ischemia [11].We expect to continue this series over the coming months and will continue to showcase both the progress in and the challenges of reducing discoveries to practice and the innovative solutions that investigators have developed. Indeed, many challenges remain.…”

mentioning

confidence: 99%

mentioning

confidence: 99%

Stem Cells and Regenerative Medicine

McNiece¹

2012

J Regen Med

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The ability to make embryonic stem cells from human cells allowed us to examine early developmental events and study human disease with human models. In the short span of a decade, over 150 lines are now available in the embryonic stem cell registry maintained by the US government [1].The remarkable discovery that an embryonic stem celllike state can be induced in virtually every adult cell type changed the way we consider doing experiments. Ever since the remarkable discovery of induced pluripotent stem cells by Takahashi and Yamanaka [2], the field has continued to evolve -with exciting discoveries furthering our understanding of early development, the process of cellular reprogramming, acquisition and maintenance of pluripotency, the determination of cell fate, and enhancing our ability to model diseases in vitro [3]. These advances coupled with parallel advances in gene engineering and gene targeting have allowed for an unprecedented ability to manipulate, perturb and thereby understand human development [4,5].The remarkable pace of development is reflected in the speed with which discoveries are moving from the bench to the bedside [6,7]. In just about a decade, two companies have obtained US Food and Drug Administration approval to conduct cell-based trials with human embryonic stem cell-derived cells, and a much larger number of trials have commenced with adult stem cells. Screening with primary cells derived from embryonic stem cells or induced pluripotent stem cells has begun, and several groups have described the generation of disease-specific or rescued lines and have shown that panels of lines can be generated [8].We felt it was important to provide a common forum where such translational studies could be discussed in a single place. Stem Cell Research and Therapy therefore invited a series of articles that highlight the rapid pace of advance and illustrate the breadth and range of the efforts that are in progress.In the present issue you will see three articles that showcase work being performed using stem cells as cellbased therapy. Gupta and colleagues describe the use of mesenchymal stem cells for cartilage repair [9], while Donnelly and colleagues describe their experience using human neural stem cells to treat spinal cord injury [10]. In the same issue, Bartel and colleagues describe their efforts to manufacture an autologous differentiated cell product for the treatment of critical limb ischemia [11].We expect to continue this series over the coming months and will continue to showcase both the progress in and the challenges of reducing discoveries to practice and the innovative solutions that investigators have developed. Indeed, many challenges remain. These include issues related to cell manufacture, consent to obtain samples, and the difficulty in designing an appropriate business model to ensure that positive results become widely available and freely accessible.I encourage our readers to send their comments and to participate in an active discussion and share the results in this forum. I...

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“…A range of biological activities relevant to tissue repair and regeneration has been demonstrated reflecting the multicellular composition of ixmyelocel-T. [16][17][18] In addition, ixmyelocel-T was associated with improved ischemic ulcer healing and a reduction in the rate of amputation in a placebo-controlled phase 2 study in patients with critical limb ischemia. 19 We report here the results of 2 phase 2A clinical trials of intramyocardial delivery of ixmyelocel-T in patients with end-stage HF because of ischemic and nonischemic dilated cardiomyopathy (DCM).…”

mentioning

confidence: 99%

“…15,16 Ixmyelocel-T is an expanded multicellular therapy cultured from autologous BMMC comprised myeloid cells (ie, granulocytes, monocytes, and mixed myeloid progenitors) and lymphoid cell types (ie, T cells, B cells, and mixed lymphoid progenitors) that express CD45 + on the cell surface, as well as CD90…”

mentioning

confidence: 99%

Safety and Efficacy of Ixmyelocel-T

Henry

Traverse

Hammon

et al. 2014

Circulation Research

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Rationale: Ixmyelocel-T is associated with a wide range of biological activities relevant to tissue repair and regeneration. Objective: To evaluate the safety and efficacy of ixmyelocel-T in 2 prospective randomized phase 2A Trials administered via minithoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy (DCM) stratified by ischemic or nonischemic status. Methods and Results: In IMPACT-DCM, patients were randomized to either ixmyelocel-T or standard-of-care control in a 3:1 ratio (n=39); ixmyelocel-T was administered intramyocardially via minithoracotomy. In Catheter-DCM, patients were randomized to either ixmyelocel-T or standard of care control in a 2:1 ratio (n=22); ixmyelocel-T was administered intramyocardially using the NOGA Myostar catheter. Only patients randomized to ixmyelocel-T underwent bone marrow aspiration and injections. In the 2 studies, a total of 61 patients were randomized, and 59 were treated or received standard of care. Fewer ischemic patients treated with ixmyelocel-T experienced a major adverse cardiovascular event during follow-up when compared with control patients. A similar benefit was not seen in the nonischemic patients. Heart failure exacerbation was the most common major adverse cardiovascular event. Ixmyelocel-T treatment was associated with improved New York Heart Association class, 6-minute walk distance, and Minnesota Living with Heart Failure Questionnaire scores in the ischemic population relative to control; a similar trend was not observed in the nonischemic population. Conclusions: Intramyocardial injection with ixmyelocel-T reduces major adverse cardiovascular event and improves symptoms in patients with ischemic DCM but not in patients with nonischemic DCM.

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The Aastrom experience

Cited by 26 publications

References 19 publications

Cell therapy for dilated cardiomyopathy: State-of-the-art

Cell therapy for dilated cardiomyopathy: State-of-the-art

Stem Cells and Regenerative Medicine

Safety and Efficacy of Ixmyelocel-T

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