Leg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.

开始日期2018-08-01

申办/合作机构

McMaster University

[+1]

NCT01353937 / Withdrawn临床1期IIT

Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers

Diabetic foot ulcers, a complication of diabetes leading to 80.000 lower limb amputations annually in the US, are a significant burden to our health system, costing more than a billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells) from the bone marrow and traffic them toward the wound, increasing the blood supply that subsequently improves wound healing. Because we are using the human body's own resources to regenerate itself by targeting and correcting the underlying pathophysiology, we believe that this novel therapy yields great promise in the treatment of diabetic foot ulcers.

开始日期2014-04-01

申办/合作机构

NYU Langone Health

[+2]

NCT01235260 / CompletedN/A

A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration

The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.

开始日期2010-03-01

申办/合作机构

Johnson & Johnson Pharmaceutical Research & Development LLC

[+1]

100 项与贝卡普勒明相关的临床结果

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100 项与贝卡普勒明相关的转化医学

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100 项与贝卡普勒明相关的专利（医药）

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130

项与贝卡普勒明相关的文献（医药）

2024-10-11·ACS Pharmacology & Translational Science

Targeting Matrix Metalloproteinase-9 for Therapeutic Intervention in Diabetic Foot Ulcers

Review

作者: Chang, Mayland

Diabetic foot ulcers (DFUs) are a complication of diabetes that have long been neglected. To date, a single drug (becaplermin containing platelet-derived growth factor, PDGF) has been approved by the FDA 27 years ago; however, it is seldom used because of its modest efficacy. The standard-of-care for DFUs is debridement, off-loading, and infection control with antibiotics, with hyperbaric oxygen (HBO) therapy being the treatment of last recourse. The paucity of understanding what accelerates diabetic wound healing results in more than 150,000 lower-limb amputations in the United States every year. A new paradigm for treatment of DFUs is proposed based on the higher levels of active matrix metalloproteinase (MMP)-9 with the more severe and infected human DFUs, and the demonstrated detrimental role of MMP-9 and the beneficial repair role of MMP-8 in diabetic mice. Selective inhibition of MMP-9 with the small molecule (R)-ND-336 lowered inflammation, reduced reactive oxygen species (ROS), and increased angiogenesis, without affecting MMP-8 to allow the natural repair mechanisms to take place. (R)-ND-336 showed better efficacy than becaplermin in diabetic mice. Becaplermin (PDGF) and HBO therapy work by decreasing MMP-9, but they do not completely suppress MMP-9 activity.

2024-04-01·Biomaterials advances

Laminin mimetic angiogenic and collagen peptide hydrogel for enhance dermal wound healing

Article

作者: Singh, Sweta ; Varshney, Raunak ; Kumar, Rajnish ; Jha, Chandan B ; Tiwari, Anjani K ; Baidya, Anurag T K ; Mathur, Rashi ; Saklani, Meenakshi

Laminins are essential in basement membrane architecture and critical in re-epithelialization and angiogenesis. These processes and collagen deposition are vital in skin wound healing. The role of angiogenic peptides in accelerating the wound-healing process has been known. The bioactive peptides could be a potential approach due to their similar effects as growth factors and inherent biocompatible and biodegradable nature with lower cost. They can also recognize ligand-receptor interaction and mimic the extracellular matrix. Here, we report novel angiogenic DYVRLAI, CDYVRLAI, angiogenic-collagen PGPIKVAV, and Ac-PGPIKVAV peptides conjugated sodium carboxymethyl cellulose hydrogel, which was designed from laminin. The designed peptide exhibits a better binding with the α₃β₁, α_vβ₃, and α₅β₁ integrins and CXCR2 receptor, indicating their angiogenic and collagen binding efficiency. The peptides were evaluated to stimulate wound healing in full-thickness excision wounds in normal and diabetic mice (type II). They demonstrated their efficacy in terms of angiogenesis (CD31), re-epithelialization through regeneration of the epidermis (H&E), and collagen deposition (MT). The synthesized peptide hydrogel (DYVRLAI and CDYVRLAI) showed enhanced wound contraction up to 10.1 % and 12.3 % on day 7^th compared to standard becaplermin gel (49 %) in a normal wound model. The encouraging results were also observed with the diabetic model, where these peptides showed a significant decrease of 5.20 and 5.17 % in wound size on day 10^th compared to the commercial gel (9.27 %). These outcomes signify that the modified angiogenic peptide is a cost effective, novel peptide motif to promote dermal wound healing in both models.

2023-12-01·Molecular immunology

Pterostilbene accelerates wound healing response in diabetic mice through Nrf2 regulation

Article

作者: Ganesh, Goutham V ; Ramkumar, Kunka Mohanram

Pterostilbene (PTS), known for its diverse beneficial effects via Nuclear factor erythroid-2 related factor (Nrf2) activation, holds potential for Diabetic Foot Ulcer (DFU) treatment. However, PTS-mediated Nrf2 regulation in diabetic wounds has yet to be elucidated. We used IC21 macrophage-conditioned media to simulate complex events that can influence the fibroblast phenotype using L929 cells during the wound healing process under a hyperglycemic microenvironment. We found that PTS attenuated fibroblast migration and alpha-smooth muscle actin (α-SMA) levels and hypoxia-inducible factor- 1 alpha (HIF1α). Furthermore, we demonstrated that wounds in diabetic mice characterized by impaired wound closure in a heightened inflammatory milieu, such as the NOD-like receptor P3 (NLRP3) and intercellular adhesion molecule 1 (ICAM1), and deficient Nrf2 response accompanying lowered Akt signaling and heme oxygenase1 (HO1) expression along with the impaired macrophage M2 marker CD206 expression, was rescued by administration of PTS. Such an elicited response was also compared favorably with the standard treatment using Regranex, a commercially available topical formulation for treating DFUs. Our findings suggest that PTS regulates Nrf2 in diabetic wounds, triggering a pro-wound healing response mediated by macrophages. This insight holds the potential for developing targeted therapies to heal chronic wounds, including DFUs.

项与贝卡普勒明相关的新闻（医药）

2024-01-30

·BioSpace

RION Announces Initiation of Phase 2A Clinical Study for Purified Exosome Product™ (PEP™) in Diabetic Foot Ulcers

RION's Phase 2A clinical trial focuses on evaluating the safety and efficacy of Platelet Exosome Product™ (PEP™) combined with TISSEEL fibrin sealant for treating Diabetic Foot Ulcers (DFU). Diabetic Foot Ulcers, affecting 18.6 million people worldwide each year, significantly impact quality of life and impose substantial economic burdens on healthcare systems. The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU. ROCHESTER, Minn.--(BUSINESS WIRE)-- RION, a clinical-stage regenerative medicine company, at the forefront of the exosome therapeutic revolution, has officially commenced a Phase 2A study aimed at assessing the efficacy and safety of its exclusive exosome regenerative therapeutic, known as Purified Exosome Product™ (PEP™), for the management of Diabetic Foot Ulcers (DFU). This press release features multimedia. View the full release here: RION, located in Rochester, MN, is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived exosomes. (Photo: Business Wire) Diabetic Foot Ulcers affect approximately 18.6 million people worldwide each year1 and are associated with increasing rates of amputation and death. The economic burden of DFUs is substantial, imposing $13 billion in cost on the US public and private healthcare systems.2 The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU. Building on the success of the Phase 1B study conducted at Mayo Clinic, RION's Phase 2A trial represents a significant step forward in the development of a regenerative biologic for Diabetic Foot Ulcers. This prospective, randomized, multi-center study will involve 40 patients across the United States. Patients will be divided into two cohorts: one receiving standard care and the other treated with PEP™ exosomes, enabling a thorough comparison of outcomes. A positive outcome in the Phase 2A trial has the potential to pave the way for a pivotal study followed by the submission of a Biologics License Application (BLA). PEP™ addresses a significant unmet medical need in the realm of diabetic wound care. Dr. Atta Behfar, Co-founder of RION, said, “The progress we've made in advancing PEP™, reflects our deep commitment to developing powerful exosome therapies that unleash the body’s ability to heal from within. Not only will this study address a critical unmet need in chronic wound care, but it’s a pivotal moment for RION. We are disrupting the boundaries of exosome technology, to develop a new generation of therapies endowed with the potential to truly transform the way we treat complex and incurable diseases.” In the United States, the treatment of DFUs remains a significant challenge in the medical community, with no new biologics approved by the US FDA for diabetic wounds since the late 1990s3. RION is committed to bringing exosome-based therapies to patients as quickly and safely as possible to transform the management and outcomes of this devastating condition. About RION RION was born out of the Mayo Clinic after two decades of research and innovation at that institution. RION is located in Rochester, MN and is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™. RION is rewriting the regenerative medicine playbook. Our cutting-edge proprietary biomanufacturing platform crafts the future of regenerative therapy, unlocking the potent secrets within these tiny cellular messengers. RION’s regenerative PEP™ technology will be integral to the therapeutic exosome revolution. About PEP™ RION's Purified Exosome Product™ (PEP™) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. PEP™ is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. RION and its scientific collaborators have performed extensive research showing the potential of PEP™ to heal a wide array of damaged tissue. The company is currently evaluating PEP™ in preclinical and clinical studies for several indications. While our focus remains on wound healing, multiple IND-enabling efforts in musculoskeletal, cardiovascular disease, pulmonary disease and women’s health disorders are creating new solutions where current standards of care cannot address unmet clinical needs. About Diabetic Foot Ulcers (DFU) Diabetic foot ulcers (DFUs) are not just wounds. These slow-healing sores on the feet are a brutal consequence of diabetes, inflicting a triple threat: excruciating pain, crippling mobility, and the specter of amputation. The numbers paint a grim picture. Up to 25% of people with diabetes will face a DFU in their lifetime4, and for almost a quarter of them also limb amputation5. In fact, every three and a half minutes in the US, a DFU becomes an amputation6. This isn't just a statistic, it's a story of lives shattered, livelihoods lost, and families forever changed. Many patients endure the agony of recurrences, their lives trapped in a cycle of healing and reopening wounds. And sadly, the shadow of mortality looms large. 40% of DFU sufferers will succumb to the condition7, making it a pervasive silent killer of diabetic communities. The economic cost is equally staggering. DFUs drain healthcare systems, piling on direct treatment expenses and crippling indirect costs from lost productivity and long-term disability. RION's journey is paved with unwavering determination. We seek to break the cycle of pain, loss, and economic burden through application of our next-generation regenerative exosome technology. We will remain undeterred in our pursuit to have PEP™ become the first biologic to be approved for the treatment of DFU in over 25 years. References 1. Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578. PMID: 37395769; PMCID: PMC10723802. 2. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660. PMID: 24186882. 3. Fang RC, Galiano RD. A review of becaplermin gel in the treatment of diabetic neuropathic foot ulcers. Biologics. 2008 Mar;2(1):1-12. doi: 10.2147/btt.s1338. PMID: 19707423; PMCID: PMC2727777. 4. Yazdanpanah L, Shahbazian H, Nazari I, Arti HR, Ahmadi F, Mohammadianinejad SE, Cheraghian B, Hesam S. Incidence and Risk Factors of Diabetic Foot Ulcer: A Population-Based Diabetic Foot Cohort (ADFC Study)-Two-Year Follow-Up Study. Int J Endocrinol. 2018 Mar 15;2018:7631659. doi: 10.1155/2018/7631659. PMID: 29736169; PMCID: PMC5875034. 5. Liao X, Li SH, El Akkawi MM, Fu XB, Liu HW, Huang YS. Surgical amputation for patients with diabetic foot ulcers: A Chinese expert panel consensus treatment guide. Front Surg. 2022 Nov 8;9:1003339. doi: 10.3389/fsurg.2022.1003339. PMID: 36425891; PMCID: PMC9679004. 6. Amputation Prevention Alliance. (n.d.). Amputation prevention alliance. Amputation Prevention Alliance | ADA. 7. Jeyaraman K, Berhane T, Hamilton M, Chandra AP, Falhammar H. Mortality in patients with diabetic foot ulcer: a retrospective study of 513 cases from a single Centre in the Northern Territory of Australia. BMC Endocr Disord. 2019 Jan 3;19(1):1. doi: 10.1186/s12902-018-0327-2. PMID: 30606164; PMCID: PMC6318899.

临床2期上市批准

100 项与贝卡普勒明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03065	贝卡普勒明	D03AX06 A01AD08	DB00102

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批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病溃疡	欧盟	Janssen-Cilag International NV	1999-03-29
糖尿病溃疡	冰岛	Janssen-Cilag International NV	1999-03-29
糖尿病溃疡	列支敦士登	Janssen-Cilag International NV	1999-03-29
糖尿病溃疡	挪威	Janssen-Cilag International NV	1999-03-29
糖尿病神经性溃疡	美国	Smith & Nephew, Inc. (Tennessee)	1997-12-16