Osteogenic Profiling of Normal Calvarial Bone

NCT02933359 | Completed

• 1 other identifier: PRO10070450
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are: i) to procure human calvarial bone, ii) to grow cells from these tissues in vitro, iii) and to evaluate the osteogenic potential of these cells.

Conditions

Fracture; Skull

Keywords

cranial vault; calvarial trauma; calvarial reconstruction

Outcome Measures

Primary Outcomes (1)

• Cell Growth

  to grow cells from the calvarial bone in vitro and freeze these collected cells for DNA analysis

  2 years

Study Arms (1)

Normal Tissue

Bone fragments and their associated bone marrow will be collected from patients at the time of surgery without any additional dissection or incisions. Bone will be finely minced and then plated in tissue culture flasks as previously reported by other groups \[7\].

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with calvarial trauma (an insult which disrupts the cranial vault requiring surgical management to correct the injury) undergoing surgical calvarial reconstruction between the ages of 2 months of age to 18 years old will be included in this study. Children will be evaluated initially at the Pittsburgh Cleft Palate and Craniofacial Center at Children's Hospital of Pittsburgh which is set up to accommodate children of all ages and their families.

You may qualify if:

• All patients between the ages of 2 months of age to 18 years with the diagnosis of pre-operative calvarial defect secondary to trauma and undergoing surgical calvarial reconstruction will be asked to contribute to this study.

You may not qualify if:

• All patient with a concurrent diagnosis of craniosynostosis or other craniofacial anomaly and any child with calvarial trauma that is not undergoing surgical calvarial reconstruction will be excluded from this study

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh Of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (11)

• Whitaker LA, Munro IR, Salyer KE, Jackson IT, Ortiz-Monasterio F, Marchac D. Combined report of problems and complications in 793 craniofacial operations. Plast Reconstr Surg. 1979 Aug;64(2):198-203. doi: 10.1097/00006534-197908000-00011.

  PMID: 377338 BACKGROUND

• Thorne, C., Grabb, W.C., and Smith, J.W. 2007. Grabb and Smith's plastic surgery. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins.

  RESULT

• Crysdale WS, Kohli-Dang N, Mullins GC, Pullerits J, Munro IR, Burke RC. Airway management in craniofacial surgery: experience in 542 patients. J Otolaryngol. 1987 Aug;16(4):207-15.

  PMID: 3656500 RESULT

• Prevot M, Renier D, Marchac D. Lack of ossification after cranioplasty for craniosynostosis: a review of relevant factors in 592 consecutive patients. J Craniofac Surg. 1993 Oct;4(4):247-54; discussion 255-6.

  PMID: 8110906 RESULT

• Dudas JR, Marra KG, Cooper GM, Penascino VM, Mooney MP, Jiang S, Rubin JP, Losee JE. The osteogenic potential of adipose-derived stem cells for the repair of rabbit calvarial defects. Ann Plast Surg. 2006 May;56(5):543-8. doi: 10.1097/01.sap.0000210629.17727.bd.

  PMID: 16641633 RESULT

• Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

  PMID: 11304456 RESULT

• Petrie C, Tholpady S, Ogle R, Botchwey E. Proliferative capacity and osteogenic potential of novel dura mater stem cells on poly-lactic-co-glycolic acid. J Biomed Mater Res A. 2008 Apr;85(1):61-71. doi: 10.1002/jbm.a.31367.

  PMID: 17688255 RESULT

• Campbell PG, Miller ED, Fisher GW, Walker LM, Weiss LE. Engineered spatial patterns of FGF-2 immobilized on fibrin direct cell organization. Biomaterials. 2005 Nov;26(33):6762-70. doi: 10.1016/j.biomaterials.2005.04.032.

  PMID: 15941581 RESULT

• Miller ED, Fisher GW, Weiss LE, Walker LM, Campbell PG. Dose-dependent cell growth in response to concentration modulated patterns of FGF-2 printed on fibrin. Biomaterials. 2006 Apr;27(10):2213-21. doi: 10.1016/j.biomaterials.2005.10.021. Epub 2005 Dec 1.

  PMID: 16325254 RESULT

• Jadlowiec J, Koch H, Zhang X, Campbell PG, Seyedain M, Sfeir C. Phosphophoryn regulates the gene expression and differentiation of NIH3T3, MC3T3-E1, and human mesenchymal stem cells via the integrin/MAPK signaling pathway. J Biol Chem. 2004 Dec 17;279(51):53323-30. doi: 10.1074/jbc.M404934200. Epub 2004 Sep 13.

  PMID: 15371433 RESULT

• Higuchi C, Myoui A, Hashimoto N, Kuriyama K, Yoshioka K, Yoshikawa H, Itoh K. Continuous inhibition of MAPK signaling promotes the early osteoblastic differentiation and mineralization of the extracellular matrix. J Bone Miner Res. 2002 Oct;17(10):1785-94. doi: 10.1359/jbmr.2002.17.10.1785.

  PMID: 12369782 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Bone samples will be collected from bone tissue that would normally be discarded during the reconstructive surgery, so no additional procedures are needed to collect the bone samples. Bone marrow tissues will be collected from patients at the time of surgery without any additional dissection or incisions. Bone will be finely minced and then plated in tissue culture flasks as previously reported by other groups. The procedure will not involve any extra incisions or dissection, as these tissues will be exposed during the reconstructive procedure. At the time of surgery one sample of tissue will be taken from otherwise discarded bone

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2010
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)