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

This study has been completed.
Sponsor:
Collaborator:
Aastrom Biosciences
Information provided by (Responsible Party):
Darnell Kaigler, University of Michigan
ClinicalTrials.gov Identifier:
NCT00755911
First received: September 17, 2008
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Alveolar Bone Loss
Biological: Tissue Repair Cells (TRC)
Device: Control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Bone Regeneration [ Time Frame: 12 months after tooth extraction ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 12 months after tooth extraction ] [ Designated as safety issue: No ]
    The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures


Enrollment: 24
Study Start Date: June 2008
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tissue Repair Cells (TRC)
Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
Biological: 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.
Other Name: Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t
Device: Control
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Other Name: Gelfoam
Sham Comparator: Control
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
Device: Control
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
Other Name: Gelfoam

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755911

Locations
United States, Michigan
University of Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Aastrom Biosciences
Investigators
Principal Investigator: Darnell Kaigler, DDS, MS, PhD University of Michigan Department of Periodontics and Oral Medicine
Study Chair: William V Giannobile, DDS, DMedSc University of Michigan Center for Oral Health Research
Study Chair: Steven Goldstein, PhD University of Michigan Henry Ruppenthal Family Professor of Orthopaedic Surgery and Bioengineering
  More Information

Additional Information:
Publications:

Responsible Party: Darnell Kaigler, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00755911     History of Changes
Other Study ID Numbers: 2008-02
Study First Received: September 17, 2008
Results First Received: January 7, 2013
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
dental
tooth
implant
extraction
Oral
Surgical
Procedures

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gelatin Sponge, Absorbable
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014