Phase Ib Open Clinical Trial to Assess the Safety of Autologous Mesenchymal Stem Cells for the Treatment of Nonrevascularizable Critical Lower Limb Ischemia

L, Riera del Moral; A, Salazar Álvarez; S, Stefanov Kiuri; Tong, Haijiang; L, Riera de Cubas; Garcı́a-Olmo, Damián; García-Arranz, Mariano

doi:10.4172/2157-7633.1000391

Cited by 4 publications

(2 citation statements)

References 22 publications

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“…Images will be centrally read by a blinded radiologist. b) Changes in disease severity according to RB category at 3, 6 and 12 months from baseline (33). This scale is usually used in patients with chronic arterial disease to classify chronic arterial disease into clinical categories (category 0: asymptomatic; category 1: mild claudication; category 2: moderate claudication; category 3: severe claudication; category 4: pain at rest; category 5: minor tissue loss; category 6; ulcer o gangrene).…”

Section: Outcome Measuresmentioning

confidence: 99%

Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in patients with critical limb ischemia and type 2 diabetes with no possibility of revascularization: Study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial).

Soria-Juan

García‐Arranz

Llanos

et al. 2021

Preprint

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Background: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. Methods: A multicenter, randomized double-blind, placebo-controlled trial has been designed. 90 eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: the control group (n=30), low cell dose treatment group (n=30), and high cell dose treatment group (n=30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. Discussion: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future.Trial registration: ClinicalTrials.gov NCT04466007. Registered on January 07, 2020.

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Section: Outcome Measuresmentioning

confidence: 99%

Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in patients with critical limb ischemia and type 2 diabetes with no possibility of revascularization: Study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial).

Soria-Juan

García‐Arranz

Llanos

et al. 2021

Preprint

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“…Pharmacologic treatment based on vasodilators and anticoagulation alone or in combination with immune modulators tends to be the first option in these cases, but sometimes this is not enough [1]. There is a growing body of evidence regarding the possible benefits of regenerative medicine based on the use of stem cells [3,4].…”

Section: Introductionmentioning

confidence: 99%

Allogeneic Adipose Mesenchymal Stem Cell Therapy in a Desperate Case of Forearm and Hand Ischemia

L¹,

Álvarez²

2018

IJST

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Cost-Effective, Safe, and Personalized Cell Therapy for Critical Limb Ischemia in Type 2 Diabetes Mellitus

et al. 2019

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Cell therapy is a progressively growing field that is rapidly moving from preclinical model development to clinical application. Outcomes obtained from clinical trials reveal the therapeutic potential of stem cell-based therapy to deal with unmet medical treatment needs for several disorders with no therapeutic options. Among adult stem cells, mesenchymal stem cells (MSCs) are the leading cell type used in advanced therapies for the treatment of autoimmune, inflammatory and vascular diseases. To date, the safety and feasibility of autologous MSC-based therapy has been established; however, their indiscriminate use has resulted in mixed outcomes in preclinical and clinical studies. While MSCs derived from diverse tissues share common properties depending on the type of clinical application, they markedly differ within clinical trials in terms of efficacy, resulting in many unanswered questions regarding the application of MSCs. Additionally, our experience in clinical trials related to critical limb ischemia pathology (CLI) shows that the therapeutic efficacy of these cells in different animal models has only been partially reproduced in humans through clinical trials. Therefore, it is crucial to develop new research to identify pitfalls, to optimize procedures and to clarify the repair mechanisms used by these cells, as well as to be able to offer a next generation of stem cell that can be routinely used in a cost-effective and safe manner in stem cell-based therapies targeting CLI.

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Phase Ib Open Clinical Trial to Assess the Safety of Autologous Mesenchymal Stem Cells for the Treatment of Nonrevascularizable Critical Lower Limb Ischemia

Cited by 4 publications

References 22 publications

Allogeneic Adipose Mesenchymal Stem Cell Therapy in a Desperate Case of Forearm and Hand Ischemia

Cost-Effective, Safe, and Personalized Cell Therapy for Critical Limb Ischemia in Type 2 Diabetes Mellitus

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