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Collection of Tissue Specimens for Analysis and Establishment of Cell Cultures

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00802607
First received: December 4, 2008
Last updated: October 5, 2010
Last verified: October 2010
  Purpose

This study will collect bone, cartilage, tendon, ligament, skin and fat tissue from patients undergoing surgery at Children's National Medical Center in Washington,

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Condition
Bone Diseases
Connective Tissue Diseases

Study Type: Observational
Official Title: Procurement of Normal and Abnormal Bone, Dermis and Adipose Tissue for Establishment of Cell Cultures and Tissue Analysis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: October 2010
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802607

Locations
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00802607     History of Changes
Other Study ID Numbers: 999909046, 09-D-N046
Study First Received: December 4, 2008
Last Updated: October 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bone Diseases
Connective Tissue Diseases

Additional relevant MeSH terms:
Bone Diseases
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014