Bone DiseasesNCT00802607
Collection of Tissue Specimens for Analysis and Establishment of Cell Cultures
An observational study of Bone Diseases and Connective Tissue Diseases, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study will collect bone, cartilage, tendon, ligament, skin and fat tissue from patients undergoing surgery at Children's National Medical Center in Washington, ... Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Diseases, Connective Tissue Diseases
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2008to 4 Oct 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient who is undergoing clinically indicated surgery that entails removal of bone with red marrow, dermis and adipose tissue.
- Patients with a documented musculoskeletal disease will be eligible for inclusion in this protocol if they are undergoing a medically indicated surgical procedure in which surgical waste containing bone and/or skin and/or fat is generated.
- Subjects under 18 years of age may be entered into this research study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens National Medical Center
Washington D.C., District of Columbia
About this study
Official title: Procurement of Normal and Abnormal Bone, Dermis and Adipose Tissue for Establishment of Cell Cultures and Tissue Analysis
This study will collect bone, cartilage, tendon, ligament, skin and fat tissue from patients undergoing surgery at Children's National Medical Center in Washington,
...
Read the detailed description
Background:
It is now apparent that virtually every human post-natal tissue contains some type of stem/progenitor cell population that is responsible for tissue turnover and repair. Our previous studies have identified a subset of human bone marrow stromal cells (BMSCs) that is multi-potent and able to regenerate bone, cartilage, myelosupportive stroma and adipocytes, whereas stromal cells derived from human spleen (SpSCs) and thymus (TSCs) only form myelosupportive stroma. Recent studies suggest that human adipose-derived stromal cells (ASCs) may be similar to BMSCs, whereas stromal cells derived from human dermis (DSCs) have none of these properties (and serve as a negative control for most experiments in vitro and in vivo). How similar or dissimilar these different stromal cell populations are has yet to be determined. Molecular profiling is needed to compare these different populations and in order to elucidate the factors that control differentiation stromal cells into one cell type or another.
Objectives:
Surgical waste (bone with red marrow, dermis, and adipose tissues) from males and females of varying ages undergoing clinically indicated surgical procedures will be used to establish stromal cell cultures to study the molecular profile and differentiation capacity of the stromal cell populations from different tissues, and to further characterize the regulation of gene expression and protein synthesis in these stem/progenitors cells.
Eligibility:
Any patient who is undergoing clinically indicated surgery that entails removal of bone with red marrow, dermis and adipose tissue.
Design:
Normal surgical waste (bone with red marrow, dermis, and adipose) from procedures that are performed on males and females at Children's Hospital will be placed in nutrient medium (provided by NIDCR) and sent to the NIDCR for the establishment of cell culture strains. Only the age, gender, site from which the tissue was removed and clinical diagnosis will be recorded. The cell cultures from the different tissues will be used to determine their phenotypic character and differentiation properties by molecular profiling, and for studies to elucidate the regulation of gene expression and protein synthesis. Similarly, a portion of the samples obtained at Children's Hospital will be used to generate histological sections of the tissues. In some cases, RNA will be extracted from the tissues for RT-PCR analysis. Normal samples (cells, sections, mRNA) will also serve as normal controls for studies performed on samples obtained from patients with various diseases recruited to NIH under current NIH protocols (97-D-0055, 97-D-0145, 01-D-0184). Pathological samples (cells, sections, mRNA) will be studied in order to elucidate the cause of disease.
- Conditions
- Bone Diseases, Connective Tissue Diseases
- Keywords
- Bone Diseases, Connective Tissue Diseases
- Medical subject headings
- Bone Diseases, Connective Tissue Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study start2 Dec 2008
- Primary completion4 Oct 2010
- Study completion4 Oct 2010
Why it stopped: Collaborating site, Children's Hospital, no longer able to provide connective tissues for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802607
- Sponsor's protocol ID
- 999909046
- Other IDs
- 09-D-N046
- Status last verified
- Oct 2010
- First submitted
- 4 Dec 2008
- Last updated
- 2 Oct 2025
- Results posted
- No
Publications
Bianco P, Riminucci M, Kuznetsov S, Robey PG. Multipotential cells in the bone marrow stroma: regulation in the context of organ physiology. Crit Rev Eukaryot Gene Expr. 1999;9(2):159-73. doi: 10.1615/critreveukargeneexpr.v9.i2.30.
PubMed 10445154Friedenstein AJ, Chailakhyan RK, Latsinik NV, Panasyuk AF, Keiliss-Borok IV. Stromal cells responsible for transferring the microenvironment of the hemopoietic tissues. Cloning in vitro and retransplantation in vivo. Transplantation. 1974 Apr;17(4):331-40. doi: 10.1097/00007890-197404000-00001. No abstract available.
PubMed 4150881Gronthos S, Franklin DM, Leddy HA, Robey PG, Storms RW, Gimble JM. Surface protein characterization of human adipose tissue-derived stromal cells. J Cell Physiol. 2001 Oct;189(1):54-63. doi: 10.1002/jcp.1138.
PubMed 11573204
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procurement of Normal and Abnormal Bone, Dermis and Adipose Tissue for Establishment of Cell Cultures and Tissue Analysis
- ClinicalTrials.gov ID
- NCT00802607
- Acronym / sponsor ID
- 999909046
- Conditions
- Bone Diseases, Connective Tissue Diseases
- Keywords
- Bone Diseases, Connective Tissue Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Collaborating site, Children's Hospital, no longer able to provide connective tissues for this study.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 2 Dec 2008 (actual)
- Primary completion
- 4 Oct 2010 (actual)
- Study completion
- 4 Oct 2010 (actual)
- First posted
- 5 Dec 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.
This study will collect bone, cartilage, tendon, ligament, skin and fat tissue from patients undergoing surgery at Children's National Medical Center in Washington,
...
Detailed description
Background:
It is now apparent that virtually every human post-natal tissue contains some type of stem/progenitor cell population that is responsible for tissue turnover and repair. Our previous studies have identified a subset of human bone marrow stromal cells (BMSCs) that is multi-potent and able to regenerate bone, cartilage, myelosupportive stroma and adipocytes, whereas stromal cells derived from human spleen (SpSCs) and thymus (TSCs) only form myelosupportive stroma. Recent studies suggest that human adipose-derived stromal cells (ASCs) may be similar to BMSCs, whereas stromal cells derived from human dermis (DSCs) have none of these properties (and serve as a negative control for most experiments in vitro and in vivo). How similar or dissimilar these different stromal cell populations are has yet to be determined. Molecular profiling is needed to compare these different populations and in order to elucidate the factors that control differentiation stromal cells into one cell type or another.
Objectives:
Surgical waste (bone with red marrow, dermis, and adipose tissues) from males and females of varying ages undergoing clinically indicated surgical procedures will be used to establish stromal cell cultures to study the molecular profile and differentiation capacity of the stromal cell populations from different tissues, and to further characterize the regulation of gene expression and protein synthesis in these stem/progenitors cells.
Eligibility:
Any patient who is undergoing clinically indicated surgery that entails removal of bone with red marrow, dermis and adipose tissue.
Design:
Normal surgical waste (bone with red marrow, dermis, and adipose) from procedures that are performed on males and females at Children's Hospital will be placed in nutrient medium (provided by NIDCR) and sent to the NIDCR for the establishment of cell culture strains. Only the age, gender, site from which the tissue was removed and clinical diagnosis will be recorded. The cell cultures from the different tissues will be used to determine their phenotypic character and differentiation properties by molecular profiling, and for studies to elucidate the regulation of gene expression and protein synthesis. Similarly, a portion of the samples obtained at Children's Hospital will be used to generate histological sections of the tissues. In some cases, RNA will be extracted from the tissues for RT-PCR analysis. Normal samples (cells, sections, mRNA) will also serve as normal controls for studies performed on samples obtained from patients with various diseases recruited to NIH under current NIH protocols (97-D-0055, 97-D-0145, 01-D-0184). Pathological samples (cells, sections, mRNA) will be studied in order to elucidate the cause of disease.
Study design
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient who is undergoing clinically indicated surgery that entails removal of bone with red marrow, dermis and adipose tissue.
- Patients with a documented musculoskeletal disease will be eligible for inclusion in this protocol if they are undergoing a medically indicated surgical procedure in which surgical waste containing bone and/or skin and/or fat is generated.
- Subjects under 18 years of age may be entered into this research study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Collaborating site, Children's Hospital, no longer able to provide connective tissues for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 10445154Bianco P, Riminucci M, Kuznetsov S, Robey PG. Multipotential cells in the bone marrow stroma: regulation in the context of organ physiology. Crit Rev Eukaryot Gene Expr. 1999;9(2):159-73. doi: 10.1615/critreveukargeneexpr.v9.i2.30.
- Background: PubMed 4150881Friedenstein AJ, Chailakhyan RK, Latsinik NV, Panasyuk AF, Keiliss-Borok IV. Stromal cells responsible for transferring the microenvironment of the hemopoietic tissues. Cloning in vitro and retransplantation in vivo. Transplantation. 1974 Apr;17(4):331-40. doi: 10.1097/00007890-197404000-00001. No abstract available.
- Background: PubMed 11573204Gronthos S, Franklin DM, Leddy HA, Robey PG, Storms RW, Gimble JM. Surface protein characterization of human adipose tissue-derived stromal cells. J Cell Physiol. 2001 Oct;189(1):54-63. doi: 10.1002/jcp.1138.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Diseases and Connective Tissue Diseases, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site 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 3 inclusion and 0 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: stopped early, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Collaborating site, Children's Hospital, no longer able to provide connective tissues for this study.). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00802607, which also lists 3 linked publications.
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 2 Oct 2025.