Clinical Trial: Osteogenic Profiling of Tissue From Children With Craniosynostosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Osteogenic Profiling of Tissue From Children With Craniosynostosis
Brief Summary:
The primary objectives of this study are
- to procure human temporalis muscle, subcutaneous adipose (fat), and bone tissue samples from children with craniosynostosis,
- to grow cells from these tissues in vitro,
- to evaluate the osteogenic potentials of these cell types.
Detailed Summary:
The screening procedures include review and collection of information from the patient's medical record, Name, Date of Birth, Medical record number, clinical diagnosis of classification of craniosynostosis, genetic screen for syndromic synostosis (FGFR, TWIST, MSX2 mutation screen), and a clinical examination at the Cleft -Craniofacial Center. During the clinical examination, the plastic surgeon will determine the presence of a craniosynostosis and the need for surgical intervention. The evaluation and surgical repair of these patients with craniosynostosis will not differ from normal, nor from the current standard of care.
In order to reconstruct, reshape, and expand the contours of the deformed craniofacial skeleton, large skin incisions and subcutaneous dissections are necessary to allow for sufficient exposure during the procedure. These large incisions and dissections are a necessary part of the reconstruction. During the normal course of the procedure, temporalis muscle, a muscle of mastication in the temporal area, and subcutaneous adipose will be visible and exposed. It is only after the plastic surgeon has obtained this standard exposure that excisional biopsies of a maximum size of 2mm X 2mm X 3mm will be taken from consented patients. 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. Biopsy samples will not be provided to secondary investigators. The muscle and adipose biopsies are research required procedures. At the time of surgery one sample of tissue will be taken from temporalis muscle, subcutaneous adipose, and bone. The investigator will review the results of the test/procedure that are part of the standard of care and results will become part of the research record. The investigators will continue to use and disclose iden
Sponsor: Children's Hospital of Pittsburgh
Current Primary Outcome: The investigators will attempt to correlate patient diagnosis with a cellular biological response. Similar work has not yet been performed, making this study a pilot study based on such a correlation. [ Time Frame: 2 years or 50 subject, Which ever happens first ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Children's Hospital of Pittsburgh
Dates:
Date Received: October 15, 2008
Date Started: April 2008
Date Completion:
Last Updated: July 25, 2016
Last Verified: July 2016
