Bone Regeneration Using Bone Marrow Stromal Cells
Data Collection
Congenital Abnormalities+3
+ Musculoskeletal Abnormalities
+ Musculoskeletal Diseases
Summary
Study start date: August 3, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.54 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps