Trial record 33 of 41 for:
dental stem cells | United States
Bone Regeneration Using Bone Marrow Stromal Cells
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00001391 |
Recruitment Status :
Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
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Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
National Institutes of Health Clinical Center (CC)
Tracking Information | |||
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First Submitted Date | November 3, 1999 | ||
First Posted Date | November 4, 1999 | ||
Last Update Posted Date | July 2, 2017 | ||
Study Start Date | August 3, 1994 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures | Not Provided | ||
Original Primary Outcome Measures | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures | Not Provided | ||
Original Secondary Outcome Measures | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Bone Regeneration Using Bone Marrow Stromal Cells | ||
Official Title | Bone Regeneration Using Bone Marrow Stromal Cells | ||
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. | ||
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 Type | Observational | ||
Study Design | Not Provided | ||
Target Follow-Up Duration | Not Provided | ||
Biospecimen | Not Provided | ||
Sampling Method | Not Provided | ||
Study Population | Not Provided | ||
Condition |
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Intervention | Not Provided | ||
Study Groups/Cohorts | Not Provided | ||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
54 | ||
Original Enrollment |
60 | ||
Study Completion Date | October 4, 2010 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria |
Males and females 18 years and older. EXCLUSION CRITERIA: Subjects may not have metabolic bone diseases, pregnancy or taking drugs affecting skeletal metabolism. |
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT00001391 | ||
Other Study ID Numbers | 940188 94-D-0188 |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Current Responsible Party | Not Provided | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor | National Institute of Dental and Craniofacial Research (NIDCR) | ||
Original Study Sponsor | Same as current | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | National Institutes of Health Clinical Center (CC) | ||
Verification Date | October 4, 2010 |