Cell Therapy for Craniofacial Bone Defects (NCT01616953) | Clinical Trial Compass
CompletedPhase 1/2
Cell Therapy for Craniofacial Bone Defects
United States18 participantsStarted 2012-08
Plain-language summary
The purpose of this research is to determine if a patient's own bone marrow tissue can help regenerate bone in the area of the jaw where an implant will be placed. The name of the process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be collected and sent to a laboratory where it will be processed to form more cells. These new cells will then be transplanted in the regenerative site. The researchers are testing to see if these cells (BRC) will help form bone. The research will also determine if the implant will be more stable in the area with new bone growth.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Age range: 18 to 60 yrs
* Gender: Male and female
* Patients must be able and willing to follow study procedures and instructions.
* Patients must have read, understood and signed an informed consent for
* Missing tooth criteria:
* Patients missing at least one maxillary lateral incisor secondary to cleft lip and/or palate:
* with compromised bone support for installation of dental implant(s) ( \> 3 mm deficiency in horizontal and/or vertical bone height)
* with adequate interdental arch space for dental implant restorations
* with bony continuity between cleft segments
* with adequate interproximal space (between adjacent teeth) for dental implant installation
* Patients missing multiple (1-4 teeth) teeth secondary to trauma:
* in maxillary or mandibular anterior segments (second premolar to second premolar)
* with compromised bone support for installation of dental implant(s) ( \> 3 mm deficiency in horizontal and/or vertical bone height)
* with adequate interdental arch space for dental implant restorations
Exclusion Criteria:
* Allergies or hypersensitivities to study related medications: dexamethasone, chlorhexidine, ibuprofen. For patients allergic to amoxicillin a comparable substitute antibiotic will be used.
* Hematologic disorders/ blood dyscrasias. Patients will have blood drawn for a complete blood count (CBC) test. Current University of Michigan Health System normal lab values are as follows: white blood…