Collection of Tissue Specimens for Analysis and Establishment of Cell Cultures

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,

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Study Overview

Status

Completed

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, D.C., District of Columbia, United States
        • Childrens National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 2, 2008

Study Completion

October 4, 2010

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

October 4, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 999909046
  • 09-D-N046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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