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Dibotermin alfa

Generic Name
Dibotermin alfa
Brand Names
Inductos
Drug Type
Biotech
CAS Number
246539-15-1
Unique Ingredient Identifier
T472P45MG6
Background

Dibotermin alfa is a recombinant human bone morphogenetic protein-2 (rhBMP-2) derived from a recombinant Chinese Hamster Ovary (CHO) cell line . It is implanted in patients undergoing bone surgeries or those with fractures. BMPs are subfamily of the transforming growth factor-β (TGF-β) superfamily that have different actions on the bone matrix . BMP-2 is a potent osteoinductive protein that plays a critical role in the differentiation of osteoprogenitor cells into osteoblasts, thus promoting bone and cartilage formation . Through enhancing osteogenesis at the site of implantation, dibotermin alfa accelerates the healing of open tibial shaft fractures and reduces the need for secondary intervention . In a prospective clinical study of patients with an open tibial fracture, administration of dibotermin alfa resulted in faster fracture- or wound-healing, significantly fewer secondary invasive interventions, and reduced infection rate post-operation . Dibotermin alfa was approved by the EMA in 2002 as Inductos for implantation matrix. In 2004, it was approved by the FDA and is marketed as Infuse. In Infuse, rhBMP is a disulfide-linked dimeric protein molecule with two major subunit species of 114 and 131 amino acids. Each subunit is glycosylated with high-mannose-type glycans .

Associated Conditions
Tibial Fractures
Associated Therapies
Single-level lumbar interbody spine fusion

Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion

Not Applicable
Not yet recruiting
Conditions
Osteoporosis
Spinal Fusion
Interventions
First Posted Date
2023-06-22
Last Posted Date
2023-06-22
Lead Sponsor
Xijing Hospital
Target Recruit Count
76
Registration Number
NCT05911477

Bone Morphogenetic Protein-2 In Grade II Furcation Defects.

Not Applicable
Completed
Conditions
Periodontitis
Interventions
Procedure: PLATELET RICH FIBRIN in grade II furcation
First Posted Date
2020-05-04
Last Posted Date
2020-05-05
Lead Sponsor
SVS Institute of Dental Sciences
Target Recruit Count
44
Registration Number
NCT04372420
Locations
🇮🇳

RV Chandra, Hyderabad, Telangana, India

RhBMP-2 in Intrabony Defects - A Randomized Controlled Trial

Phase 2
Completed
Conditions
Periodontitis
Interventions
Procedure: PRF
First Posted Date
2020-04-30
Last Posted Date
2020-04-30
Lead Sponsor
SVS Institute of Dental Sciences
Target Recruit Count
40
Registration Number
NCT04368650
Locations
🇮🇳

SVS Institute of Dental Sciences, Mahabubnagar, Hyderabad, Andhra Pradesh, India

Periodontally Accelerated Osteogenic Orthodontics With BMP2

Phase 2
Completed
Conditions
Malocclusion
Interventions
Other: Conventional Corticotomy
First Posted Date
2018-01-11
Last Posted Date
2018-01-11
Lead Sponsor
SVS Institute of Dental Sciences
Target Recruit Count
30
Registration Number
NCT03396900
Locations
🇮🇳

SVS Institute of Dental Sciences, Mahabubnagar, Hyderabad, Andhra Pradesh, India

Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment

Phase 1
Completed
Conditions
Bone Degenerative Changes
Osteoarthritis
Degenerative Disorder of Bone
Interventions
Procedure: Autologous bone graft
First Posted Date
2012-09-21
Last Posted Date
2017-10-05
Lead Sponsor
Northern Orthopaedic Division, Denmark
Target Recruit Count
41
Registration Number
NCT01690260
Locations
🇩🇰

Orthopaedic Surgery Research Unit, Aalborg University Hospital, Aalborg, Denmark

Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

Phase 3
Completed
Conditions
Missing Teeth
Interventions
Device: Autogenous bone graft
Procedure: Augmentation surgery
First Posted Date
2012-02-29
Last Posted Date
2021-12-02
Lead Sponsor
University of Zurich
Target Recruit Count
24
Registration Number
NCT01541345
Locations
🇦🇹

Department of Oral Surgery & Radiology, Dental School, Medical University of Graz, Graz, Austria

🇨🇭

Center of Dental Medicine Clinic of Reconstructive Dentistry, Zurich, Switzerland

A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

Phase 2
Terminated
Conditions
Fractures
Interventions
First Posted Date
2006-10-13
Last Posted Date
2013-02-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
367
Registration Number
NCT00387686
Locations
🇬🇧

Pfizer Investigational Site, Norwich, United Kingdom

Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

Phase 2
Completed
Conditions
Fractures
Interventions
Other: surgical intervention alone
First Posted Date
2006-10-06
Last Posted Date
2013-02-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
108
Registration Number
NCT00384358
Locations
🇬🇧

Pfizer Investigational Site, Norwich, United Kingdom

A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

Phase 2
Completed
Conditions
Fractures
Interventions
First Posted Date
2006-10-06
Last Posted Date
2013-02-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
139
Registration Number
NCT00384852

Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

Phase 1
Completed
Conditions
Osteoarthritis
First Posted Date
2005-10-21
Last Posted Date
2006-10-06
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
6
Registration Number
NCT00243295
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