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

NCT00755911 | Completed Phase 1 Results DMC

• 1 other identifier: 2008-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Keywords

dental; tooth; implant; extraction; Oral; Surgical; Procedures

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months after tooth extraction

Secondary Outcomes (1)

• Number of Participants Who Successfully Received Dental Implant Fixtures

  12 months after tooth extraction

Study Arms (2)

Tissue Repair Cells (TRC)

EXPERIMENTAL

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

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

Control

SHAM COMPARATOR

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

Device: Control

Interventions

Tissue Repair Cells (TRC) 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.

Also known as: Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t

Tissue Repair Cells (TRC)

Control DEVICE

Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction

Also known as: Gelfoam

Control; Tissue Repair Cells (TRC)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Michigan: lead
• Vericel Corporation: collaborator

Study Sites (1)

University of Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

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MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Darnell Kaigler
• Organization: University of Michigan

dkaigler@umich.edu

734-998-1468

Study Officials

• Darnell Kaigler, DDS, MS, PhD

  University of Michigan Department of Periodontics and Oral Medicine

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: July 3, 2015
• Results First Posted: April 15, 2014

Record last verified: 2015-05

Locations

US (1)