Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
NCT ID: NCT00755911
Last Updated: 2015-07-03
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-06-30
Study Completion Date
2012-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Alveolar Bone Loss
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Tissue Repair Cells (TRC)
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Group Type
EXPERIMENTAL
Tissue Repair Cells (TRC)
Intervention Type
BIOLOGICAL
30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket.
Control
Intervention Type
DEVICE
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Control
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Group Type
SHAM_COMPARATOR
Control
Intervention Type
DEVICE
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Interventions
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Tissue Repair Cells (TRC)
30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket.
Intervention Type
BIOLOGICAL
Control
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Intervention Type
DEVICE
Other Intervention Names
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Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t
Gelfoam
Eligibility Criteria
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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
* 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.
* 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
* 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.
* 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
Minimum Eligible Age
20 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Vericel Corporation
INDUSTRY
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
lead
Responsible Party
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Darnell Kaigler
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Darnell Kaigler, DDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Department of Periodontics and Oral Medicine
William V Giannobile, DDS, DMedSc
Role: STUDY_CHAIR
University of Michigan Center for Oral Health Research
Steven Goldstein, PhD
Role: STUDY_CHAIR
University of Michigan Henry Ruppenthal Family Professor of Orthopaedic Surgery and Bioengineering
Locations
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University of Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States
Site Status
Countries
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United States
References
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DERIVED
Related Links
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http://www.umengage.org
University of Michigan Clinical Research Homepage
Other Identifiers
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2008-02
Identifier Type: -
Identifier Source: org_study_id
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