Bone Regeneration Using Bone Marrow Stromal Cells

Sponsor
National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001391
Collaborator
(none)
54
1
194
0.3

Study Details

Study Description

Brief Summary

Deficient or inappropriate healing of bone impacts clinical decision-making and treatment options in orthopedics, oral and maxillofacial surgery, plastic surgery and periodontics. While a number of auto- and allografting techniques have been used to regenerate craniofacial defects caused by infective, neoplastic or trauma-induced bone loss, each method has significant limitations. Our research group in the Craniofacial and Skeletal Diseases Branch of NIDCR has developed methods to culture and expand cell populations derived from mouse bone marrow stroma. We believe that an important next step is to apply the information gained in animal studies to treat osseous defects in humans. We propose to examine the potential of cultured human bone marrow stromal cells to serve as an abundant source of osteoblastic progenitor cells. These cells will ultimately be used to graft craniofacial osseous defects. In the course of this study we will: (1) develop methods for the propagation and enrichment of osteoblastic progenitor cells from bone marrow stroma; (2) test various vehicles for the transfer of bone marrow stromal cells to osseous defects in recipient animals; (3) determine optimal culturing and transplantation conditions for the eventual transplantation of bone marrow stromal cells into human recipients. These studies will define the parameters of bone marrow stromal cell transplantation and will generate models for future therapeutic strategies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Deficient or inappropriate healing of bone impacts clinical decision-making and treatment options in orthopedics, oral and maxillofacial surgery, plastic surgery and periodontics. While a number of auto- and allografting techniques have been used to regenerate craniofacial defects caused by infective, neoplastic or trauma-induced bone loss, each method has significant limitations. Our research group in the Craniofacial and Skeletal Diseases Branch of NIDCR has developed methods to culture and expand cell populations derived from mouse bone marrow stroma. We believe that an important next step is to apply the information gained in animal studies to treat osseous defects in humans. We propose to examine the potential of cultured human bone marrow stromal cells to serve as an abundant source of osteoblastic progenitor cells. These cells will ultimately be used to graft craniofacial osseous defects. In the course of this study we will: (1) develop methods for the propagation and enrichment of osteoblastic progenitor cells from bone marrow stroma; (2) test various vehicles for the transfer of bone marrow stromal cells to osseous defects in recipient animals; (3) determine optimal culturing and transplantation conditions for the eventual transplantation of bone marrow stromal cells into human recipients. These studies will define the parameters of bone marrow stromal cell transplantation and will generate models for future therapeutic strategies.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Official Title:
    Bone Regeneration Using Bone Marrow Stromal Cells
    Study Start Date :
    Aug 3, 1994
    Study Completion Date :
    Oct 4, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      • INCLUSION CRITERIA:

      Males and females 18 years and older.

      EXCLUSION CRITERIA:

      Subjects may not have metabolic bone diseases, pregnancy or taking drugs affecting skeletal metabolism.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Institute of Dental and Craniofacial Research (NIDCR)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00001391
      Other Study ID Numbers:
      • 940188
      • 94-D-0188
      First Posted:
      Nov 4, 1999
      Last Update Posted:
      Jul 2, 2017
      Last Verified:
      Oct 4, 2010

      Study Results

      No Results Posted as of Jul 2, 2017