Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy

Phase 1

Completed

Conditions: Alveolar Bone Loss

Interventions: Device: Control
Biological: Tissue Repair Cells (TRC)

Registration Number: NCT00755911

Lead Sponsor: University of Michigan

Brief Summary: The purpose of this research is to determine if a subject's own bone marrow tissue can help regenerate bone in the area of his/her jaw where a tooth has been removed using Tissue Repair Cell (TRC) Therapy.

Detailed Description: A sample of the subject's bone marrow tissue will be collected and sent to a laboratory where it will be processed to form cells. The new cells are transplanted into the tooth socket after the tooth has been removed. The researchers are testing to see if these cells (TRC) will help form bone. The research will also determine if the implant the subject receives will be more stable in the area with new bone growth.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Age range: 20 to 70 years
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 form
Patients must require tooth extraction as a result of caries, periodontal disease, or tooth fracture

Exclusion Criteria

Allergies or hypersensitivities to study related medications: amoxicillin, dexamethasone, chlorhexidine, ibuprofen, ranitidine
Hematologic disorders/ blood dyscrasias
Active infectious disease
Liver or kidney dysfunction/failure- Patients will have blood drawn for serum laboratory tests, including creatinine, blood urea nitrogen (BUN), aspartate aminotransferase (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); BUN (8-20 mg/dl); AST (8-30 IU/L); ALT (7-35 IU/L); Bilirubin (0.2-1.2 mg/dl).
Endocrine disorders/dysfunctions (i.e Type I and II diabetes)
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 bone mass density (BMD) determination: Normal = T score at or above -1.0 SD; Osteopenia = T score between -1.0 and -2.5 SD; Osteoporosis = T score at or below -2.5 standard deviation (SD). Although a dexa scan will not be required, all post-menopausal women receiving osteoporosis/osteopenia related therapy will receive a dexa scan as part of their standard medical care.
Additionally, individuals who have a medical history significant for diabetes will not be included in the study.
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.
Individuals who have a BMI outside normal limits or a BMI that deems them overweight (BMI >25) will be excluded due to potential difficulties in locating appropriate surgical entry of the iliac crest during bone marrow aspiration procedure.
The following additional exclusion criteria for regenerative sites are in alignment with those described and adapted for using bone morphogenetic protein (BMPs) to regenerate buccal wall defects (Fiorellini, Howell et al. 2005):
Patients < 20 and > 60 years of age
Pregnant women- Female patients who are of childbearing potential are excluded except those who are using hormonal or barrier methods of birth control (oral or parenteral contraceptives, transdermal patch, diaphragm plus spermicide, or condoms). Pregnancy status will be determined with a urine test and patients who are pregnant, as determined by a positive test, will be excluded from the study
Patients with acute sinusitis
Patients with congenital or metabolic bone disorders
Current smokers (have smoked within 6 mos. of study onset)
Presence of < 4 mm of bone from apex of tooth to the alveolar crest
< 2 mm bone from apex to floor of maxillary sinus

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Tissue Repair Cells (TRC)	Tissue Repair Cells (TRC)	Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Tissue Repair Cells (TRC)	Control	Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier

Primary Outcome Measures

Name	Time	Method
Bone Regeneration	12 months after tooth extraction	The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction. * Safety was assessed through adverse event reporting * Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Successfully Received Dental Implant Fixtures	12 months after tooth extraction	The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures