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Minimizing the severity of rhBMP-2-induced inflammation and heterotopic ossification with a polyelectrolyte carrier incorporating heparin on microbead templates.

AbstractSTUDY DESIGN:
A rodent model of posterior spinal fusion.
OBJECTIVE:
The aim of this study was to evaluate the efficacy of low-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered with a heparin based polylectrolyte complex (PEC) carrier in facilitating posterior spinal fusion while concurrently minimizing seroma and heterotopic ossification.
SUMMARY OF BACKGROUND DATA:
rhBMP-2 is being used to augment spinal fusion. However, complications such as heterotopic ossification and local soft tissue swellings have been reported. These are attributed to supraphysiological amount of rhBMP-2 and the poor modulation capacity of absorbable collagen sponge.
METHODS:
Forty rats were randomized into 6 groups as follows. Group I: absorbable collagen sponge without rhBMP-2 (n = 4); group II: positive control, absorbable collagen sponge + 10 μg rhBMP-2 (n = 4); group III: alginate-(poly-L-lysine)-heparin (PEC) without rhBMP-2 (n = 8); group IV: PEC + 4.5 μg rhBMP-2 (n = 8); group V: PEC + 1.5 μg rhBMP-2 (n = 8); group VI: PEC + 0.5 μg rhBMP-2 (n = 8).
RESULTS:
Between postoperative days 5 and 7, seroma was observed in all rhBMP-2 implanted groups irrespective of carrier and dose. However, the rate and size of seroma differed considerably. Although all animals (100%) in positive control group showed seroma, only one animal (12.5%) in group VI developed seroma at the implant site. The size of seroma in group VI was significantly smaller than that in positive control group. Micro-computed tomography evaluation revealed comparable mean fusion scores in all rhBMP-2 implanted groups. More importantly, although new bone was well contained within the cage in group VI, heterotopic ossification beyond the cage was observed in positive control group.
CONCLUSION:
A new carrier has demonstrated capacity to minimize seroma formation as well as heterotopic ossification associated with rhBMP-2 by reducing the efficacious dose needed for consistent fusion. The results of this study indicate that PEC alginate microbeads may represent a new opportunity to define an efficient rhBMP-2 carrier.
AuthorsMing Wang, Sunny Akogwu Abbah, Tao Hu, Soo Yein Toh, Raymond Wing Moon Lam, James Choh-Hong Goh, Hee-Kit Wong
JournalSpine (Spine (Phila Pa 1976)) Vol. 38 Issue 17 Pg. 1452-8 (Aug 01 2013) ISSN: 1528-1159 [Electronic] United States
PMID23380826 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Alginates
  • Anticoagulants
  • Bone Morphogenetic Protein 2
  • Drug Carriers
  • Recombinant Proteins
  • Transforming Growth Factor beta
  • recombinant human bone morphogenetic protein-2
  • Polylysine
  • Heparin
Topics
  • Alginates (chemistry)
  • Animals
  • Anticoagulants (chemistry, pharmacology)
  • Bone Morphogenetic Protein 2 (adverse effects, chemistry, pharmacology)
  • Drug Carriers (chemistry)
  • Heparin (chemistry, pharmacology)
  • Humans
  • Inflammation (chemically induced, prevention & control)
  • Microspheres
  • Ossification, Heterotopic (chemically induced, prevention & control)
  • Polylysine (chemistry)
  • Random Allocation
  • Rats
  • Rats, Sprague-Dawley
  • Recombinant Proteins (adverse effects, chemistry, pharmacology)
  • Seroma (chemically induced, prevention & control)
  • Spinal Fusion (methods)
  • Transforming Growth Factor beta (adverse effects, chemistry, pharmacology)
  • Treatment Outcome
  • X-Ray Microtomography

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