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

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tissue Repair Cells (TRC)
Control
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring dental, tooth, implant, extraction, Oral, Surgical, Procedures

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Center for Oral Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Tissue Repair Cells (TRC)

Control

Arm Description

Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier

Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.

Outcomes

Primary Outcome Measures

Bone Regeneration
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

Number of Participants Who Successfully Received Dental Implant Fixtures
The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures

Full Information

First Posted
September 17, 2008
Last Updated
May 28, 2015
Sponsor
University of Michigan
Collaborators
Vericel Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00755911
Brief Title
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Official Title
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Vericel Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
dental, tooth, implant, extraction, Oral, Surgical, Procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tissue Repair Cells (TRC)
Arm Type
Experimental
Arm Description
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Intervention Type
Biological
Intervention Name(s)
Tissue Repair Cells (TRC)
Other Intervention Name(s)
Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t
Intervention Description
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
Device
Intervention Name(s)
Control
Other Intervention Name(s)
Gelfoam
Intervention Description
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Primary Outcome Measure Information:
Title
Bone Regeneration
Description
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)
Time Frame
12 months after tooth extraction
Secondary Outcome Measure Information:
Title
Number of Participants Who Successfully Received Dental Implant Fixtures
Description
The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures
Time Frame
12 months after tooth extraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darnell Kaigler, DDS, MS, PhD
Organizational Affiliation
University of Michigan Department of Periodontics and Oral Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William V Giannobile, DDS, DMedSc
Organizational Affiliation
University of Michigan Center for Oral Health Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steven Goldstein, PhD
Organizational Affiliation
University of Michigan Henry Ruppenthal Family Professor of Orthopaedic Surgery and Bioengineering
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Center for Oral Health Research
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States

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Links:
URL
http://www.umengage.org
Description
University of Michigan Clinical Research Homepage

Learn more about this trial

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

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