Osteogenic Profiling of Tissue From Children With Craniosynostosis

Completed · Not applicable

Conditions studied: Craniosynostosis

In brief

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.

Key facts

Study ID

NCT00773643

Run by

University of Pittsburgh

People needed

29

Starts

2008-04-01

Expected to finish

2018-02-01

Last updated by the study team

2018-10-23

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children with craniosynostosis undergoing surgical calvarial reconstruction between the ages of 2 months of age to 18 years old will be included in this study. This surgery is the standard of care in the sequence of treatment for craniosynostosis patients. Pediatric plastic surgeons at the Cleft-Craniofacial Center at Children's Hospital of Pittsburgh of UPMC work primarily with children as part of their patient populations and are trained for this during their residencies. 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.
• Approximately twelve to twenty children are normally treated in this facility each year.
• All patients will be asked to contribute to this study.
• The research study satisfies risk Criterion 3 (45 CFR 46.406) for the inclusion of children in research whereas the research involves an intervention or procedure that presents greater than minimal risk to the involved children and which does not hold out the potential for direct individual benefit. Pediatric patients undergoing surgical repair craniosynostosis normally do not have a biopsy of the temporalis muscle or the adipose tissue of the scalp (experimental procedures). These biopsies will be performed by a plastic surgeon who is experienced in the surgical repair of pediatric patients and poses no additional likely or common risks above the surgical repair of the calvaria. Infrequent risks may include a slight increase in bleeding representing a few more drops of blood loss. Rare risks, occurring in less than one percent of patients, may subject the patient to injury to nerves in a small area of the biopsy which may result in a decrease of muscle function in that area. This intervention could provide detailed, basic information regarding the relationship between the progenitor cells and craniosynostosis.

You may not qualify if…

• All patients not undergoing calvarial reconstruction to correct craniosynostosis will be excluded from this study.
• Selection will be based on an individual's willingness to participate in the study.
• A subject will also be removed from the research study if the targeted muscle, adipose, or bone tissues are unavailable due to necrosis, infection, or if the removal of the tissues may adversely effect the surgical outcome in some way.

Where it is running

• Joseph Losee, MD — Pittsburgh, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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