Osteogenic Profiling of Tissue From Children With Craniosynostosis

NCT00773643 | Completed

• 1 other identifier: 07110284
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Craniosynostosis

Keywords

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.

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years or 50 subject, Which ever happens first

Study Arms (1)

Tissue Sample

EXPERIMENTAL

A biopsy of the patient's temporalis muscle, subcutaneous adipose, and bone tissue is the experimental procedure. The procedure will not involve any extra incisions or dissection, as these tissues will be exposed during the reconstructive procedure. A very small fragment of each tissue type, 2mm X 2mm X 3mm biopsy, will be removed.

Other: biopsy

Interventions

biopsy OTHER

A biopsy of the patient's temporalis muscle, subcutaneous adipose, and bone tissue is the experimental procedure. The procedure will not involve any extra incisions or dissection, as these tissues will be exposed during the reconstructive procedure. A very small fragment of each tissue type, 2mm X 2mm X 3mm biopsy, will be removed.

Tissue Sample

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

Joseph Losee, MD

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15231, United States

Location

MeSH Terms

Conditions

Craniosynostoses; Platelet Glycoprotein IV Deficiency

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jospeh Losee, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ross H. Musgrave Professor of Pediatric Plastic Surgery Executive Vice-Chair and Program Director Department of Plastic Surgery University of Pittsburgh Medical Center

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

US (2)