Clinical use of bone morphogenetic proteins BMP-2 and BMP-7: analysis of current clinical trials

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Abstract

Bone morphogenetic proteins have been used in clinical practice in orthopedics, spine surgery, and maxillofacial surgery for nearly a decade. According to research findings, in most cases the frequency of coalescence when using bone morphogenetic proteins is comparable to or higer that the corresponding indicator when using an autograft. To date, BMP-2 and BMP-7 are commercially available for clinical use and have shown efficacy equal to that of autograft in bone defect replacement.

This study analyzes existing clinical trials registered on the clinicaltirals.gov website for the therapeutic use of BMP-2 and BMP-7 in pathologies of the musculoskeletal system.

The search strategy was to use the material from the clinicaltrials.gov website, which focuses on key terms such as bonemorphogenetic protein 2 or BMP-2, bone morphogenetic protein 7 or BMP-7, recombinant bone morphogenetic protein 2 or rhBMP-2”, “recombinant bone morphogenetic protein 7 or rhBMP-7”, “InductOs”, “Op1”, “bone” and “diseases of the musculoskeletal system”. The inclusion and exclusion criteria were divided into two stages.

By October 2022, about 85 clinical trials had been registered using BMP-2 and about 12 using BMP-7. Most of the studies are in Phase 2, Phase 2–3, or Phase 4. Most of them focus on areas such as tibial trauma therapy and spinal surgery. However, only 12 clinical trials using BMP-2 provide meaningful results. All the clinical trials have similar preparation methods, and 12 clinical trials have provided positive results without serious side effects.

There is a wide potential for clinical use of BMP-2. Many preclinical and clinical studies on the use of BMP-2 and BMP-7 are currently underway; their future results will further explore their therapeutic potential in treating musculoskeletal diseases.

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About the authors

Ural F. Mukhametov

Kuvatov Republican Clinical Hospital

Email: ufa.rkbkuv@doctorrb.ru
ORCID iD: 0000-0003-3694-3302

MD, Cand. Sci. (Med.)

Russian Federation, 3 Lenin St., Ufa, 450008

Sergey V. Lyulin

Medical Center Carmel

Email: carmel74@yandex.ru
ORCID iD: 0000-0002-2549-1059
SPIN-code: 4968-8680
Scopus Author ID: 6701421057

MD, Dr. Sci. (Med.)

Russian Federation, Chelyabinsk

Dmitry Yu. Borzunov

Ural State Medical University

Email: borzunov@bk.ru
ORCID iD: 0000-0003-3720-5467
SPIN-code: 6858-8005
Scopus Author ID: 17433431500

MD, Dr. Sci. (Med.), Professor

Russian Federation, Ekaterinburg

Ilgiz F. Gareev

Bashkir State Medical University

Author for correspondence.
Email: ilgiz_gareev@mail.ru
ORCID iD: 0000-0002-4965-0835
SPIN-code: 3839-0621
Scopus Author ID: 57206481534

MD, PhD

Russian Federation, 3 Lenin St., Ufa, 450008

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Flowchart of the study selection process

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3. Fig. 2. Comparative analysis of the clinical trials using bone morphogenetic proteins BMP-2 and BMP-7: a, stage 1; b, stage 2

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4. Fig. 3. Dynamics of temporary (yearly) registrations of the clinical trials to test the clinical potential of bone morphogenetic proteins BMP-2 (a) and BMP-7 (b) on the clinicaltrials.gov

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5. Fig. 4. Distribution of the registered clinical trials on the use of bone morphogenetic protein BMP-2: a, b — by phase; с, d — by status

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6. Fig. 5. Distribution of the registered clinical trials on the use of bone morphogenetic protein BMP-7: a, b — by phase; с, d — by status

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7. Fig. 6. Comparative analysis of the clinical trials on the use of bone morphogenetic proteins BMP-2 and BMP-7 depending on the stages. * p < 0.001; ** p < 0.05

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8. Fig. 7. Distribution of registered clinical trials on the use of bone morphogenetic protein BMP-2 (a) and BMP-7 (b) by localization in the world

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