CraniosynostosisNCT00773643
Osteogenic Profiling of Tissue From Children With Craniosynostosis
A study testing biopsy in people with Craniosynostosis, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Craniosynostosis
- What is being tested?
- biopsy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joseph Losee, MD
Pittsburgh, Pennsylvania, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15231
About this study
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.
Read the detailed description
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 identifiable medical information and keep stored tissue samples for seven years. After this seven year period, all identifying information will be removed samples will be destroyed.
The muscle and adipose tissue biopsies will take approximately 10 minutes. The samples of bone tissue will be discarded as a result of the reconstructive surgery and will, therefore, not add any time to the surgical procedure.
Subjects will not be notified of the results of this study because the results will not impact the clinical care of the subject.
- Conditions
- Craniosynostosis
- Being tested
- biopsy
- 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.
- Medical subject headings
- Craniosynostoses, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years or 50 subject, Which ever happens first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniosynostosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Losee, University of Pittsburgh
- Investigators
- Jospeh Losee, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773643
- Sponsor's protocol ID
- 07110284
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2008
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteogenic Profiling of Tissue From Children With Craniosynostosis
- ClinicalTrials.gov ID
- NCT00773643
- Acronym / sponsor ID
- 07110284
- 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 identifiable medical information and keep stored tissue samples for seven years. After this seven year period, all identifying information will be removed samples will be destroyed.
The muscle and adipose tissue biopsies will take approximately 10 minutes. The samples of bone tissue will be discarded as a result of the reconstructive surgery and will, therefore, not add any time to the surgical procedure.
Subjects will not be notified of the results of this study because the results will not impact the clinical care of the subject.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue Sample | Experimental | Other: biopsyA 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. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsyA 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 | Tissue Sample |
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Related trials for Craniosynostosis
Not yet recruiting
Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis
Metopic Craniosynostosis, Craniosynostosis
RecruitingObservational study
Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery
Craniosynostosis
Active, not recruitingPhase 2
Efficacy of Amicar for Children Having Craniofacial Surgery
Craniosynostosis
Active, not recruitingObservational study
Pathogenetic Basis of Aortopathy and Aortic Valve Disease
Aortopathies, Thoracic Aortic Aneurysm
RecruitingObservational study
Ocular Characteristics in Patients With Craniosynostosis
Craniosynostosis, Strabismus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jospeh Losee, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy in people with Craniosynostosis, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.