Delving into the Latest Updates on Dibotermin alfa with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

Bone morphogenetic protein-2, Dibotermin alfa (USAN/INN), INFUSE Bone Graft

+ [7]

Target

BMPR1A

Action

stimulants

Mechanism

BMPR1A stimulants(Bone morphogenetic protein receptor type-1A stimulants)

Therapeutic Areas

Skin and Musculoskeletal DiseasesOther Diseases

Active Indication

Intervertebral Disc DegenerationTibial Fractures

Inactive Indication

Hip FracturesHumeral FracturesOsteoarthritis+ [2]

Originator Organization

Medtronic Plc

Active Organization

Medtronic BioPharma BV

Inactive Organization

Wyeth AB

Pfizer Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (09 Sep 2002),

Intervertebral Disc DegenerationTibial Fractures

Regulation-

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Structure/Sequence

Sequence Code 22299

Source: *****

Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial - Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial:Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial

Start Date01 May 2022

Sponsor / Collaborator-

NCT04610021

/ Not yet recruitingNot ApplicableIIT

Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity

Adult spinal deformity surgery is a complex procedure that involves many risks and complications. Bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery.
Autologous bone has been considered the "gold-standard" for obtaining a spinal fusion. However, the source from which to obtain it is limited. Furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options.
I-Factor ™ Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles.
In the literature there are no articles which identify bone formation with the i-Factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending

Start Date01 Mar 2021

Sponsor / Collaborator-

100 Clinical Results associated with Dibotermin alfa

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100 Translational Medicine associated with Dibotermin alfa

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100 Patents (Medical) associated with Dibotermin alfa

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426

Literatures (Medical) associated with Dibotermin alfa

19 Nov 2024·International journal of oral implantology (Berlin, Germany)

Submerged vertical bone augmentation of supraosseous peri-implant defects.

Article

Author: Urban, Istvan ; Wang, Hom-Lay ; Chen, Zhaozhao

CASE PRESENTATIONAlthough most peri-implant lesions feature a combined defect configuration that involves both supra- and infraosseous components, regenerating the supraosseous part is considered the optimal approach, albeit a challenging one, and often requires vertical bone augmentation. This report provides a detailed description of submerged membrane techniques for vertical bone augmentation around supraosseous peri-implant defects. Cases involving different types of membrane (both resorbable and non-resorbable) with or without the use of bone graft are presented. In the first case, the patient had a mild supraosseous defect that was managed using the sausage technique with collagen matrix soaked with human recombinant bone morphogenetic protein-2. In cases two to five, titanium-reinforced dense polytetrafluoroethylene membranes were employed.CONCLUSIONThe reconstruction of supraosseous peri-implant defects is technique sensitive but can be achieved when adhering to the principles of space maintenance and submerged healing.

15 Sep 2024·Journal of the American Academy of Orthopaedic Surgeons

Midterm Outcomes of Multimodal Approach to Treating Severe Scoliosis in Patients With Osteogenesis Imperfecta

Article

Author: Almeida da Silva, Luiz Carlos ; Bober, Michael B ; Hori, Yusuke ; Yorgova, Petya K ; Kruse, Richard W ; Carroll, Ricki ; Franzone, Jeanne M ; McDonald, Tyler C ; Kaymaz, Burak ; Thornley, Patrick ; Shah, Suken A ; Rogers, Kenneth J

Introduction:The surgical management of severe scoliosis in patients with osteogenesis imperfecta (OI) is challenging because of curve rigidity, small stature, and inherent bone fragility. This study evaluated the midterm outcomes of our multimodal approach to address these issues, integrating perioperative bisphosphonate therapy, preoperative/intraoperative traction, various osteotomies, segmental pedicle screw instrumentation with cement augmentation, and bone morphogenetic protein-2 application.Methods:A single-center retrospective review of 30 patients (average age 14.1 ± 2.2 years; 18 were female) diagnosed with OI and scoliosis was conducted. These patients underwent posterior spinal fusion between 2008 and 2020 and completed a minimum follow-up of 2 years. We measured radiographic parameters at each visit and reviewed the incidence of complications. A mixed-effects model was used to evaluate changes in radiographic parameters from preoperative measurements to the first and latest follow-ups.Results:The patient cohort consisted of 2 individuals with type I OI, 20 with type III, 6 with type IV, and 2 with other types (types V and VIII). Surgical intervention led to a notable improvement in the major curve magnitude from 76° to 36°, with no notable correction loss. In addition, the minor curve, apical vertical translation, lowest instrumented vertebra tilt, and pelvic obliquity were also improved. In the sagittal plane, thoracic kyphosis and lumbar lordosis remained unchanged while thoracolumbar kyphosis markedly improved. Two patients experienced proximal junctional kyphosis with screw pullout, one of whom required revision surgery. One patient developed a superficial infection that was successfully treated with oral antibiotics. No instances of neurologic deficits or cement extravasation were observed.Discussion:This study demonstrated the effectiveness and safety of our multimodal approach to treating scoliosis in patients with OI, achieving a 53% major curve correction with minimal complications over 2-year follow-up. These findings provide notable insights into managing scoliosis in this population.Level of evidence:Level IV (case series).

01 Sep 2024·Journal of Biomaterials Applications

Development of gelatin-methacryloyl composite carriers for bone morphogenetic Protein-2 delivery: A potential strategy for spinal fusion

Article

Author: Xu, Zhengwei ; Zhang, Xiaobo ; Yao, Xin ; Li, Tao ; Gao, Xidan ; Hu, Yicun

To reduce the risk of nonunion after spinal fusion surgery, the in situ transplantation of bone marrow mesenchymal stem cells (BMSCs) induced toward osteogenic differentiation by bone morphogenetic protein-2 (BMP2) has been proven effective. However, the current biological agents used for transplantation have limitations, such as a short half-life and low bioavailability. To address this, our study utilized a safe and effective gelatin-methacryloyl (GelMA) as a carrier for BMP2. In vitro, experiments were conducted to observe the ability of this composite vehicle to induce osteogenic differentiation of BMSCs. The results showed that the GelMA hydrogel, with its critical properties and controlled release performance of BMP2, exhibited a slow release of BMP2 over 30 days. Moreover, the GelMA hydrogel not only enhanced the proliferation activity of BMSCs but also significantly promoted their osteogenic differentiation ability, surpassing the BMP2 effects. To investigate the potential of the GelMA-BMP2 composite vehicle, a rabbit model was employed to explore its ability to induce in situ intervertebral fusion by BMSCs. Transplantation experiments in rabbits demonstrated the effective induction of intervertebral bone fusion by the GelMA-BMP2-BMSC composite vehicle. In conclusion, the GelMA-BMP2-BMSC composite vehicle shows promising prospects in preclinical translational therapy for spinal intervertebral fusion. It addresses the limitations of current biological agents and offers a controlled release of BMP2, enhancing the proliferation and osteogenic differentiation of BMSCs.

100 Deals associated with Dibotermin alfa

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External Link

KEGG	Wiki	ATC	Drug Bank
D03779	-	M05BC01	DB11639

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Intervertebral Disc Degeneration	Norway	Medtronic BioPharma BV	09 Sep 2002
Intervertebral Disc Degeneration	Liechtenstein	Medtronic BioPharma BV	09 Sep 2002
Intervertebral Disc Degeneration	Iceland	Medtronic BioPharma BV	09 Sep 2002
Intervertebral Disc Degeneration	European Union	Medtronic BioPharma BV	09 Sep 2002
Tibial Fractures	Liechtenstein	Medtronic BioPharma BV	09 Sep 2002
Tibial Fractures	European Union	Medtronic BioPharma BV	09 Sep 2002
Tibial Fractures	Iceland	Medtronic BioPharma BV	09 Sep 2002
Tibial Fractures	Norway	Medtronic BioPharma BV	09 Sep 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tibial Fractures	Phase 2	Serbia	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	Germany	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	Australia	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	Argentina	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	United Kingdom	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	Canada	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	India	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	Sweden	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	United States	Wyeth AB	01 Nov 2006
Tibial Fractures	Phase 2	France	Wyeth AB	01 Nov 2006

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Dibotermin alfa

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation