NCT00435877

Brief Summary

This study will determine if bone marrow stromal cells can be used as a graft for regeneration of bony defects. These cells have the ability to form new bone and to support the formation of blood. Stromal cells have been identified in other tissues, such as the dermis (underside of skin), spleen, thymus and fat, but it is not known whether these cells can make bone and support blood formation as well as bone marrow stromal cells. Patients undergoing surgery at Suburban Hospital in Bethesda, Maryland, in which some of the bone, dermis, spleen, thymus or fat tissue is removed may be eligible for this study. For this study, a small piece of the tissue that is removed during surgery for examination by a pathologist will be used for research. Stromal cells from the specimen will be collected and grown in the laboratory. The genes and proteins in the different cell types will be compared, and the ability of stromal cells from the different tissues to make bone and to support the formation of blood will be studied.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2012

Completed
Last Updated

December 17, 2019

Status Verified

November 5, 2012

First QC Date

February 15, 2007

Last Update Submit

December 14, 2019

Conditions

Keywords

Connective TissueStromal CellsSurgical WasteIn Vivo StudiesTissue Analysis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient over the age of 18 years who is undergoing a clinically indicated or elective surgery that entails removal of bone with red marrow,periosteum, dermis, spleen, thymus, muscle and adipose tissue.
  • All patients must sign a document of informed consent indicating their understanding that the specimens collected and demographic information provided is only for research purposes.

You may not qualify if:

  • Any patient that has a history of metabolic bone disease.
  • Any patient that has cancer of any type, or has been treated for cancer of any type.
  • Any patient that has been treated with a reagent known to affect bone metabolism (bisphosphonates, steroids, vitamin D)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Related Publications (3)

  • 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.

    PMID: 10445154BACKGROUND
  • Friedenstein 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.

    PMID: 4150881BACKGROUND
  • Gronthos 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.

    PMID: 11573204BACKGROUND

Study Officials

  • Pamela G Robey, Ph.D.

    National Institute of Dental and Craniofacial Research (NIDCR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 16, 2007

Study Start

January 29, 2007

Study Completion

November 5, 2012

Last Updated

December 17, 2019

Record last verified: 2012-11-05

Locations