Cell Therapy for Craniofacial Bone Defects

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 count (WBC: 4.0-10.0 x103/cmm), red blood count (RBC: male 4.50-5.90 x103/cmm; female 3.90-5.30x103/cmm), hemoglobin (HgB: male 13-17.3gm/dl; female 12-16gm/dl), Hct (male 39-50.2%; female 35-48%), mean corpuscular volume (MCV: 80-100fl), mean corpuscular hemoglobin (MCH: 25-35 pg), mean corpuscular hemoglobin concentration (MCHC: 30-37%), red cell distribution width (RDW: 11.5-15.5%), Plt (150-450x103/cmm).
• Active infectious disease
• Liver or kidney dysfunction/failure- Patients will have blood drawn for serum laboratory tests, including creatinine, blood urea nitrogen, aspartate aminotransferase test (AST), alanine aminotransferase test (ALT), and bilirubin.
• All of these must be within normal limits for a patient to be included in the study.
• Current University of Michigan Health System normal lab values are as follows: *Creatinine (male 0.7-1.3 mg/dl
• female 0.5-1.0 mg/dl)
• blood urea nitrogen (BUN: 8-20 mg/dl)
• AST (8-30 IU/L)
• ALT (7-35 IU/L)
• Bilirubin (0.2-1.2 mg/dl).
• Laboratory values that will define normal renal and hepatic function, as well as criteria for exclusion of metabolic bone disease are consistent with those established by the University of Michigan Health System (UMHS).
• Normal clinical values will be used to help assure the health of all subjects in this trial.
• Potential subjects whose laboratory values fall outside the UMHS normal ranges will be required to have medical clearance from their primary care provider prior to participation.
• Endocrine disorders/dysfunctions (i.e uncontrolled Type I or II diabetes, glycosylated hemoglobin [HA1C > 7%})
• Cancer - The explicit definition of cancer used to exclude patients is consistent with that described by the National Cancer Institute (NCI), National Institutes of Health. According to NCI, cancer is any disease in which abnormal cells divide without control and invade nearby tissues (invasive disease). These include carcinomas, sarcomas, leukemias, and lymphomas. Any patient with a history of these invasive diseases will be excluded from the study.
• Patients who currently use bisphosphonates or have a history of bisphosphonate use will be excluded from the trial.
• HIV+
• Metabolic Bone Diseases- Patients with metabolic bone diseases such as Paget's disease, hypercalcemia, moderate to severe vitamin D3 abnormalities or any other metabolic bone disease including osteoporosis and osteoporotic fractures will be excluded. The following scale will be used to determine osteoporosis in patients who have had a