This study is seeking to evaluate the binding of a commercially-available, recombinant human osteoinductive growth factor, rhBMP-2, to a human blood derived product scaffold, enhanced Platelet-rich fibrin (E-PRF), and the release of such a growth factor over time in an in vitro (laboratory) environment. The investigators will compare these release kinetics to those of the FDA approved carrier for rhBMP-2, an absorbable collagen sponge (ACS), a combination of E-PRF and ACS, and E-PRF alone.

开始日期2025-08-01

申办/合作机构

The University of Alabama at Birmingham

CTRI/2024/05/067147

/ Not yet recruiting临床4期IIT

Evaluation of the effect of Recombinant Human Bone Morphogenic Protein-2 on crestal bone height and osseointegration around endosseous implants - nil

开始日期2024-06-10

申办/合作机构-

NCT05719181

/ Recruiting临床1期IIT

Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study of 6\12\2021 to20\4\2023

Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

开始日期2021-12-06

申办/合作机构

University of Baghdad

100 项与 DWP-431 相关的临床结果

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100 项与 DWP-431 相关的转化医学

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2,120

项与 DWP-431 相关的文献（医药）

2025-03-01·Global Spine Journal

Usage Trends and Safety Profile of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Column Tumor Surgery: A National Matched Cohort Analysis

Article

作者: Colman, Matthew W. ; Nolte, Michael T. ; Berlinberg, Elyse ; Pawlowski, Hanna ; Federico, Vincent P. ; Prabhu, Michael ; Patel, Karan S. ; Munim, Mohammed A.

Study Design Retrospective Cohort Analysis. Objective The purpose of this study is to investigate national rates of rhBMP-2 utilization in spinal tumor surgery and examine its association with postoperative complications, revisions, and carcinogenicity. Methods All patients diagnosed with primary or metastatic spinal tumors with subsequent surgical intervention involving a spinal fusion procedure were identified in PearlDiver. Patients were 1:1 matched into 2 cohorts according to rhBMP-2 usage. Postoperative complications and revisions were examined at 1 month, 3 months, 6 months, and 1 year after fusion. New cancer incidence following spinal tumor surgery was assessed until 5 years postoperatively. Results A total of 11,198 patients underwent fusion surgery after resection of spinal tumors between 2005 and 2020, with 909 cases reporting the use of rhBMP-2 (8.1%). An annualized analysis revealed that the proportion of spine tumor fusion procedures utilizing rhBMP-2 has been significantly decreasing ( R2 = .859, P < .001), with the most recent annual utilization rate at 1.1%. At least 3 months after surgery, significantly increased incidences of surgical site (11.4% vs 3.3%, P = .03) and systemic infections (8.1% vs 1.6%, P = .02) were observed in patients who underwent fusion with rhBMP-2. Across all time points, no significant differences were observed in survival, implant removal, revision rates, or new cancer diagnoses. Conclusion This analysis demonstrated significantly declining national utilization rates. Spinal tumor cases utilizing rhBMP-2 sustained greater rates of surgical site and systemic infections. rhBMP-2 usage did not significantly reduce the risk of mortality, implant failure, or reoperation.

2025-03-01·Global Spine Journal

An Update in Complication Rates Associated With Anterior Lumbar Surgery: A Systematic Review and Meta-Analysis

Review

作者: Donnally, Chester J. ; Ezeonu, Teeto ; Shenoy, Kartik ; Robinson, William A. ; Patel, Parthik D. ; Narayanan, Rajkishen ; Karamian, Brian A. ; Canseco, Jose A. ; Vaccaro, Alexander R. ; Kepler, Christopher K. ; Issa, Tariq Z. ; Sellig, Mason ; Divi, Srikanth N.

Study Design Systematic Review and meta-analysis. Objective To conduct an updated systematic review and meta-analysis of complications associated with different anterior fusion techniques/approaches and adjuvant resources (i.e., computed tomography angiography (CTA), rhBMP-2, and access surgeons). Methods A systematic review was conducted from 1/1/2014-4/1/2024 for studies evaluating the incidence of complications associated with anterior lumbar procedures. Comparisons of complications were made between surgical approach, use of CTA, rhBMP-2, and access surgeons. Meta-analyses were conducted using a generalized linear mixed model. Results 54 studies were included in the final analysis with 8066 patients and an average follow-up of 31.2 months. The overall complication rate associated with anterior lumbar surgery was 13.1%, including an intraoperative complication rate of 3.8%, postoperative complication rate of 7.4%, infection rate of 1.5%, and reoperation rate of 1.7%. Forest plot analysis showed no significant difference in overall complication rates between open and mini-open techniques, although mini-open techniques were associated with lower overall reoperation rates. The use of CTA was associated with an increase in intraoperative and overall complications, and the use of an access surgeon was associated with a decreased risk of reoperation. The use of rhBMP-2 was not associated with overall complication risk. Conclusions While anterior lumbar surgery provides numerous benefits, surgeons and patients alike should be aware of the complication and safety profile prior to surgery. High quality studies are warranted to help elucidate the true benefit of certain techniques and adjuvant resources in reducing complications.

2025-02-01·Plastic & Reconstructive Surgery

Failure Rates Based on Alveolar Cleft Volume: Analysis of the Critical-Size Defect for Alveolar Bone Grafting

Article

作者: Fahradyan, Artur ; Shakoori, Pasha ; Alfeerawi, Sarah ; Choi, Dylan G. ; Magee, William P. ; Urata, Mark M. ; Hammoudeh, Jeffrey A. ; Trotter, Collean ; Roohani, Idean ; Youn, Simon

Background:Alveolar bone grafting (ABG) using iliac crest bone graft (ICBG) is the best practice for children with complete cleft lip and palate. With the advent of recombinant human bone morphogenetic protein (rhBMP-2) and demineralized bone matrix (DBM), excellent results can be achieved while avoiding donor-site morbidity. This study aimed to determine critical-size defects by analyzing graft failure rates for ICBG and rhBMP-2/DBM to guide surgeons performing ABG.Methods:A retrospective review was conducted evaluating patients who underwent ABG from 2016 through 2022. Patients with preoperative and postoperative cone beam computed tomography (CBCT) imaging were included. Volumetric defect sizes were calculated using preoperative imaging. Graft success criteria were based on both clinical and radiographic outcomes. Logistic regressions analyzed graft failure rates to identify an optimal cutoff, which defined the critical-size defect.Results:A total of 93 patients were included. Bone graft cohorts included ICBG (n = 30) and rhBMP-2/DBM (n = 63). The critical-size defects were calculated to be 810 mm3 and 885 mm3 for ICBG and rhBMP-2/DBM, respectively. There were significantly higher graft failure rates beyond the critical size compared with below for both ICBG (71.4% versus 0.0%; P < 0.001) and rhBMP-2/DBM (65.0% versus 14.0%; P < 0.001).Conclusions:This study identified critical-size defects based on alveolar cleft volume for ICBG or rhBMP-2/DBM with higher graft failure rates beyond the predicted thresholds. Distinct ranges in cleft volume were identified where patients might benefit from each select graft option.CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, III.

项与 DWP-431 相关的新闻（医药）

2024-02-01

·PRNewswire

U.S. FDA GRANTS THERADAPTIVE IDE APPROVAL FOR PHASE I/II CLINICAL TRIALS

Global study will assess the safety and efficacy of the company's lead spinal fusion product, OsteoAdapt SP FREDERICK, Md., Feb. 1, 2024 /PRNewswire/ -- Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion. With an aging population, more people will suffer from debilitating spinal conditions. Around 40% of adults over the age of 40 and 80% of adults over the age of 80 have at least one degenerated vertebral disc. Currently, more than 1 in 6 Americans are over the age of 65 and this proportion is increasing. However, current spinal fusion treatments can leave patients with sub-optimal outcomes, and often suffering from excruciating pain. Theradaptive's spinal fusion product, OsteoAdapt SP, aims to provide safer and more effective treatments for transforaminal lumbar interbody fusion (TLIF) procedures, whereby vertebrae in the lower back are fused in a minimally invasive posterior procedure. It is used for a range of conditions including degenerative disc disease, lumbar spondylolisthesis, and spinal stenosis. Theradaptive's therapeutic platform aims to improve efficacy and safety by creating material-binding variants of recombinant proteins that bind to medical devices, implants and injectable carriers to achieve anatomically-precise and locally-sustained therapeutic delivery. IDE approval from the FDA serves as a key milestone for this platform and will generate its first human clinical data, thus opening a new chapter in Theradaptive's growth into a clinical-stage company. Starting in April, this study of 80 patients will assess the safety and efficacy of OsteoAdapt SP. The feasibility study will also identify the required OsteoAdapt SP dose that will be investigated in a future pivotal study. The study will produce early interim data to permit interim assessments of safety and efficacy. More details can be found at ClinicalTrials.gov identifier NCT06154005. Theradaptive's path to FDA IDE approval has been aided by their unprecedented three Breakthrough Medical Device Designations which provide them with priority review and interactive communication regarding device development and clinical trial protocols. John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, said: "The FDA created Breakthrough Device Designations to accelerate the clinical trials and approval processes for devices that promise to improve on current treatments for life-threatening and debilitating conditions. The fact that OsteoAdapt has been awarded three Breakthrough Device Designations is an indicator of the ground-breaking nature of the technology. The FDA has extensive experience with rh-BMP2, which was used to design the AMP2 biologic within OsteoAdapt. Based on the safety profile of OsteoAdapt, we will be allowed to combine Phase I and II trials. We can now apply these insights to our other programs in dental, orthopedics, and sports medicine." Dr. Brett Freedman, Chair, Spine Surgery Division, Mayo Clinic said: "The FDA's approval to combine Phase I and II into one feasibility trial, along with three Breakthrough Designations is a strong signal that OsteoAdapt SP shows promise to significantly improve our current therapeutic offerings in the area of bone graft, and more importantly that OsteoAdapt SP represents a valid solution to long unmet needs in spinal fusion. OsteoAdapt has beaten the standard of care in every preclinical study to date and we're excited by the prospect of proving the same in humans and overcoming limitations with the current standard of care". Theradaptive's clinical work is supported in part by a Department of Defense Clinical Trial Award under the Peer Reviewed Medical Research Program and the Maryland Stem Cell Research Fund. In addition to spine, Theradaptive has active development programs in trauma, orthopedic, dental, craniomaxillofacial repair, and bone-tendon and bone-ligament repair for sports medicine indications, all based on the OsteoAdapt product. The company is actively collaborating with physicians to advance each of those indications into the clinic on the back of its IDE approval in spine. Theradaptive CEO and founder Luis Alvarez, PhD, commented on synergies with these other programs: "Advancing OsteoAdapt into the clinic under this IDE will also enable acceleration of partnered programs that use OsteoAdapt as a component. One key example is our partnership with 3D Systems where we are developing products that incorporate OsteoAdapt in 3D printed implants using our OrthoTex 3D printable graft containment system. This accelerates the development of truly regenerative 3D printed implants for applications in cranial repair and sports medicine." About Theradaptive Founded in 2016 and headquartered in Maryland, U.S., Theradaptive is a venture-backed biopharmaceutical and medical device company with the goal of leveraging its therapeutic delivery platform to deliver biologics where they are needed in the body with high local precision and high persistence to address unmet medical needs. Theradaptive's innovative platform is enabling the development of new therapeutics in spine, orthopedics, and soft tissue repair as well as targeted immuno-oncology. The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $7,408,939, through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0693. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. Contact: Marcus McCabe [email protected] SOURCE Theradaptive

临床研究

2024-01-03

·NS Medical Devices

FDA grants breakthrough status to CGBio’s Novosis Putty bone material

The Korean bio-regenerative medicine developer has developed the second-generation material using recombinant human bone morphogenetic protein 2 for spine implantation CGBio has secured FDA breakthrough status for Novosis Putty. (Credit: Kenny Eliason on Unsplash) CGBio has received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA) for its advanced bone substitute material, Novosis Putty. The Korean bio-regenerative medicine developer has developed this second-generation material using recombinant human bone morphogenetic protein 2 (rhBMP-2). Novosis Putty is said to be the first such implantable medical device in Korea for spine implantation. It incorporates a ceramic-based synthetic scaffold with advanced moldability and osteoconductive properties. In addition, the material features advanced sustained-release formulation technology (SLOREL) from its predecessor, Novosis Ortho. Novosis Putty’s key ingredient is rhBMP-2, which is a mass-produced by South Korean pharma firm Daewoong Pharmaceutical. According to CGBio, the protein supports bone regeneration and helps transform stem cells into bone cells in cases of bone defect. It is globally known as Nebotermin and recognised by organisations, including the World Health Organization (WHO). CGBio CEO Hyun Seung Yu said: “The breakthrough device designation for Novosis Putty is further proof of CGBio’s technological prowess, innovation, and potential. “With the designation’s emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through Novosis Putty.” The breakthrough status for the bone substitute material is expected to result in prioritised FDA support during the approval process. During this support, the American health regulator maintains continuous communication, assigns a specialised review team, and prioritises the review of clinical trial design to approval. This in turn will accelerate the FDA approval and allow rapid entry into the US market compared to other devices. CGBio has finished a preclinical trial for Novosis Putty and is conducting clinical trials to identify the optimal dosage. The bio-regenerative medicine firm has plans to apply for US confirmatory clinical trials in the first half of 2024.

突破性疗法临床研究

2024-01-02

·PRNewswire

CGBio's 'NOVOSIS PUTTY' Receives FDA 'Breakthrough Device Designation,' Accelerate Entry into the US Market

The first Korean developed medical device for spine implantation Expecte to receive faster approval in the U.S. by priority support from the FDA NOVOSIS PUTTY, combining bone-forming proteins and ceramic scaffolds, induces rapid bone formation SEOUL, South Korea, Jan. 2, 2024 /PRNewswire/ -- CGBio (CEO Hyun Seung Yu), a Korean company specializing in bio-regenerative medicine, announced on the 2nd that its advanced bone substitute material, "NOVOSIS PUTTY", has been granted 'Breakthrough Device Designation' (BDD) by the U.S. Food and Drug Administration (FDA). This material incorporates recombinant human bone morphogenetic protein 2 (rhBMP-2). On September 15, 2023, FDA published an update to the guidance document – "Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff. The Breakthrough Program is intended to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA, 510(k), and De Novo, consistent with the Agency's mission to protect and promote public health. The FDA considers all of these factors to determine whether a device is 'reasonably expected to provide more effective treatment or diagnosis,'" according to the guidance. NOVOSIS PUTTY's designation marks the first case for implantable device in Korea. Despite being a high-risk permanent implant, NOVOSIS PUTTY's efficacy and innovative aspects are recognized internationally. Devices with 'Breakthrough Device Designation' benefit from prioritized FDA support during the approval process. This support includes continuous communication with the FDA, assignment of a specialized review team, and prioritized review of everything from clinical trial design to approval. This streamlined approach speeds up FDA approval, allowing for quicker entry into the U.S. market compared to other devices. According to SmartTrak, the market for growth factor bone substitutes in North America is expected to grow from USD 0.66 billion in 2022 to USD 0.78 billion in 2029, with an average annual growth rate of 4.7%. NOVOSIS PUTTY, a second-generation product, features a ceramic-based synthetic scaffold with superior moldability and osteoconductive properties, and incorporates advanced sustained-release formulation technology (SLOREL™) from its predecessor, NOVOSIS Ortho. A key ingredient in NOVOSIS PUTTY is rhBMP-2, mass-producedx by Daewoong Pharmaceutical Co., Ltd., a leader in the South Korean pharmaceutical industry. This protein plays a crucial role in bone regeneration, transforming stem cells into bone cells in cases of bone defect. Known internationally as 'Nebotermin' and recognized by organizations including the WHO, Daewoong's rhBMP-2 has earned global acclaim for its impact on health. Hydroxyapatite (HA) ceramic material, bone graft substitute that acts as a scaffold of rhBMP-2 at the same time, allows for controlled release of rhBMP-2, reducing the risk of unwanted bone growth and surrounding soft tissue swelling, unlike collagen sponge-based scaffolds. It enables high-density bone formation with lower rhBMP-2 doses. Its synthetic polymer hydrogel component, Poloxamer 407 hydrogel, also allows customizable shaping. CGBio has completed preclinical studies for U.S. confirmatory clinical trials of NOVOSIS PUTTY and is conducting clinical trials to determine the optimal dosage, with plans to apply for U.S. confirmatory clinical trials in the first half of 2024. Hyun Seung Yu, CEO of CGBio, commented, "The breakthrough device designation for NOVOSIS PUTTY is further proof of CGBio's technological prowess, innovation, and potential. With the designation's emphasis on quickly bringing beneficial products to market, we are committed to helping more patients overcome diseases and return to healthy lives through NOVOSIS PUTTY." Jumi Han, head of CGBio's U.S. Development Center, stated, "The 'Breakthrough Device Designation' for NOVOSIS PUTTY confirms that regulatory authorities are prioritizing support for our product development. We are accelerating U.S. clinical trials to demonstrate its efficacy and safety." About CGBio CGBio began with the mission of 'Pursuing the Improvement of Quality of Life,' specializing in the production and sale of therapeutic materials for reconstructing musculoskeletal tissues damaged by diseases. Expanding its scope, the company now also provides materials for the beauty and plastic surgery sectors. Building on biomaterial-based technology, CGBio collaborates with clinical experts to supply essential products for clinical use and products that are convenient for use in clinical settings. More detailed information can be found at (). About Daewoong Pharmaceutical Daewoong Pharmaceutical, a leading global pharmaceutical company based in South Korea, is dedicated to improving consumer quality of life through its innovative products. Its self-developed NABOTA, a botulinum toxin type-A, is Asia's first FDA-approved botulinum toxin, and Daewoong has also developed novel drugs for GERD, using the active ingredient Fexuprazan, and for diabetes with Enavogliflozin for two consecutive years. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at [email protected]. SOURCE CGBio

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KEGG	Wiki	ATC	Drug Bank
-	-	M05BC	DB11639

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适应症	国家/地区	公司	日期
牙槽骨质丢失	韩国	Daewoong Pharmaceutical Co., Ltd.	2014-06-25

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适应症	最高研发状态	国家/地区	公司	日期
脊柱融合	临床前	韩国	Daewoong Pharmaceutical Co., Ltd.	2024-05-20

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03527966 (CTgov)	临床4期	脊椎骨关节炎	3	5cc Vivigen (Intervention Group - 5cc Vivigen and Local Autograft)	製簾構範鹽齋廠壓膚鬱(範醖觸膚廠齋蓋範遞鑰) = 選鏇醖衊遞選獵獵築顧蓋觸鑰廠簾鹽選膚襯夢 (積夢獵範選網網廠鬱壓, 醖衊齋願齋廠廠築醖網 ~ 鑰顧遞壓鹹餘廠餘簾齋) 更多	-	2019-08-07
				local autograft (Control Group - Small Kit rhBMP-2 With Local Autograft)	鏇窪網遞鏇襯憲鬱範積(簾範鏇齋餘餘襯願憲廠) = 製醖鬱醖願簾繭壓鏇蓋選網窪齋糧鑰醖鏇餘憲 (蓋鬱願構鑰窪齋壓顧範, 餘範範膚鏇壓積鏇襯願 ~ 鹽鹹艱膚艱顧積糧衊鬱) 更多