THERAPY DOSSIER · th-94bbcd67dfb3

Recombinant human bone morphogenetic protein-2 delivered in RGD-functionalised alginate hydrogel with a polycaprolactone nanofibre mesh

Biologic

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Fracture
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: Not recorded
Note: Not recorded

Clinical trials 9

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02609074 ↗Injury indicationPHASE4completed

CPC/rhBMP-2 Micro-scaffolds as Bone Substitute for Bone Regeneration

Bone Fracture

Enrolment: 81 · Results not recorded

NCT00707265 ↗PHASE3completed

rhBMP-2 and Compression Resistant Matrix With CD HORIZON for Posterolateral Lumbar Fusion

Degenerative Disc Disease

Enrolment: 463 · Results not recorded

NCT01415908 ↗PHASE3terminated

INFUSE Bone Graft With CAPSTONE Spinal System for TLIF

Lumbar Spine Degeneration

Enrolment: 15 · Results not recorded

NCT01634308 ↗PHASE3completed

Bongros-BMP Compared to Bio-oss for Alveolar Bone Regeneration After Maxillary Sinus Floor Augmentation

Alveolar Bone Regeneration

Enrolment not recorded · Results not recorded

NCT01491386 ↗NAcompleted

rhBMP-2 and Absorbable Collagen Sponge With LT-CAGE for Anterior Lumbar Interbody Fusion

Degenerative Disc Disease

Enrolment: 279 · Results not recorded

NCT01491399 ↗NAcompleted

rhBMP-2 and Absorbable Collagen Sponge With CORNERSTONE-SR and ATLANTIS in Degenerative Cervical Disc Disease

Degenerative Cervical Disc Disease

Enrolment: 33 · Results not recorded

NCT01430299 ↗NAcompleted

Integra Accell Evo3 Demineralized Bone Matrix in Instrumented Posterolateral Lumbar Fusion (rhBMP-2 comparator)

Stenosis · Spondylosis

Enrolment: 43 · Results not recorded

NCT01764906 ↗NAunknown

Clinical Study to Evaluate Efficacy and Safety of Novosis in Posterolateral Fusion

Posterolateral Fusion

Enrolment: 90 · Results not recorded

NCT06715345 ↗NAactive not recruiting

Novosis Putty for Bone Fusion in Posterior Instrumentation and TLIF for Degenerative Lumbar Disease

Degenerative Lumbar Diseases

Enrolment: 48 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 30480339 ↗2019Mixed findings

Impaired bone healing following treatment of established nonunion correlates with serum cytokine expression.

RatFractureFemurSASCO Sprague-DawleyFemalen = 34 treated animals: acute 2 micrograms n=10, delayed 2 micr…Local intra-defect delivery by syringe injection through mesh perforations2 or 5 micrograms of BMP-2 per 150 microlitres of final 2 p…Acute (at defect creation) versus delayed (8 weeks after the initial injury, on…

Model: Critically sized 8 mm segmental defect created in the mid-diaphysis of the femur with an oscillating saw and stabilised with a radiolucent polysulfone fixation plate; for delayed groups the defect was left empty for 8 weeks to establish nonunion, then reopened with removal of mineralised end capping and soft tissue ingrowth

All acutely treated defects bridged compared with 50 percent of delayed 2 microgram and 75 percent of delayed 5 microgram defects, and the delayed deficit in bone formation and mechanical strength was not rescued by a 2.5 fold dose increase, with non-responders showing higher serum tumour necrosis…

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.9. Machine-extracted fields require source verification.

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