Alveolar Bone LossPhase 1/2NCT00755911
Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
A Phase 1/2 study testing Tissue Repair Cells (TRC) in people with Alveolar Bone Loss, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Tissue Repair Cells (TRC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
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.
Read the 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.
- Conditions
- Alveolar Bone Loss
- Being tested
- Tissue Repair Cells (TRC), Control
- Keywords
- dental, tooth, implant, extraction, Oral, Surgical, Procedures
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Repair Cells (TRC)Biological
Also called Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t
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.
ControlDevice
Also called Gelfoam
Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Tissue Repair Cells (TRC) | Experimental | Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier Receives: 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. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months after tooth extraction
Secondary outcomes (1)
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
Measured: 12 months after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Vericel Corporation
- Responsible party
- Principal investigator, Darnell Kaigler, University of Michigan
- Investigators
- Darnell Kaigler, DDS, MS, PhD, Principal investigator, University of Michigan Department of Periodontics and Oral MedicineWilliam V Giannobile, DDS, DMedSc, Study chair, University of Michigan Center for Oral Health ResearchSteven Goldstein, PhD, Study chair, University of Michigan Henry Ruppenthal Family Professor of Orthopaedic Surgery and Bioengineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755911
- Sponsor's protocol ID
- 2008-02
- Status last verified
- May 2015
- First submitted
- 17 Sep 2008
- Last updated
- 3 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.
PubMed 7246093Albrektsson T, Lekholm U. Osseointegration: current state of the art. Dent Clin North Am. 1989 Oct;33(4):537-54.
PubMed 2680652Amler MH. The time sequence of tissue regeneration in human extraction wounds. Oral Surg Oral Med Oral Pathol. 1969 Mar;27(3):309-18. doi: 10.1016/0030-4220(69)90357-0. No abstract available.
PubMed 5251474Atwood DA. Reduction of residual ridges: a major oral disease entity. J Prosthet Dent. 1971 Sep;26(3):266-79. doi: 10.1016/0022-3913(71)90069-2. No abstract available.
PubMed 4934947Atwood DA, Coy WA. Clinical, cephalometric, and densitometric study of reduction of residual ridges. J Prosthet Dent. 1971 Sep;26(3):280-95. doi: 10.1016/0022-3913(71)90070-9. No abstract available.
PubMed 5284182Caldwell J, Palsson BO, Locey B, Emerson SG. Culture perfusion schedules influence the metabolic activity and granulocyte-macrophage colony-stimulating factor production rates of human bone marrow stromal cells. J Cell Physiol. 1991 May;147(2):344-53. doi: 10.1002/jcp.1041470221.
PubMed 2040665Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
PubMed 15842256Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.
PubMed 12956657Carlsson L, Rostlund T, Albrektsson B, Albrektsson T, Branemark PI. Osseointegration of titanium implants. Acta Orthop Scand. 1986 Aug;57(4):285-9. doi: 10.3109/17453678608994393.
PubMed 3788488Cochran D. Implant therapy I. Ann Periodontol. 1996 Nov;1(1):707-91. doi: 10.1902/annals.1996.1.1.707. No abstract available.
PubMed 9118278Colter DC, Class R, DiGirolamo CM, Prockop DJ. Rapid expansion of recycling stem cells in cultures of plastic-adherent cells from human bone marrow. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3213-8. doi: 10.1073/pnas.97.7.3213.
PubMed 10725391De Kok IJ, Drapeau SJ, Young R, Cooper LF. Evaluation of mesenchymal stem cells following implantation in alveolar sockets: a canine safety study. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):511-8.
PubMed 16161734Evian CI, Rosenberg ES, Coslet JG, Corn H. The osteogenic activity of bone removed from healing extraction sockets in humans. J Periodontol. 1982 Feb;53(2):81-5. doi: 10.1902/jop.1982.53.2.81.
PubMed 6950085Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly LC, Spagnoli D, Toljanic J, Jones A, Nevins M. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol. 2005 Apr;76(4):605-13. doi: 10.1902/jop.2005.76.4.605.
PubMed 15857102Friedenstein AJ, Ivanov-Smolenski AA, Chajlakjan RK, Gorskaya UF, Kuralesova AI, Latzinik NW, Gerasimow UW. Origin of bone marrow stromal mechanocytes in radiochimeras and heterotopic transplants. Exp Hematol. 1978 May;6(5):440-4.
PubMed 350596
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy
- ClinicalTrials.gov ID
- NCT00755911
- Acronym / sponsor ID
- 2008-02
- Conditions
- Alveolar Bone Loss
- Keywords
- dental, tooth, implant, extraction, Oral, Surgical, Procedures
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Vericel Corporation
- Study start
- Jun 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Posted 15 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue Repair Cells (TRC) | Experimental | Biological: Tissue Repair Cells (TRC), Device: ControlSubjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier |
| Control | Sham comparator | Device: ControlSubjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Repair Cells (TRC)Also: Tissue Repair Cells, Bone Repair Cells, ixmyelocel-t30-50 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. | Biological | Tissue Repair Cells (TRC) |
| ControlAlso: GelfoamControl subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction | Device | Control, Tissue Repair Cells (TRC) |
Primary outcome
Bone Regeneration
Time frame: 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)
1 secondary outcome
Number of Participants Who Successfully Received Dental Implant Fixtures
Time frame: 12 months after tooth extraction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7246093Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.
- Background: PubMed 2680652Albrektsson T, Lekholm U. Osseointegration: current state of the art. Dent Clin North Am. 1989 Oct;33(4):537-54.
- Background: PubMed 5251474Amler MH. The time sequence of tissue regeneration in human extraction wounds. Oral Surg Oral Med Oral Pathol. 1969 Mar;27(3):309-18. doi: 10.1016/0030-4220(69)90357-0. No abstract available.
- Background: PubMed 4934947Atwood DA. Reduction of residual ridges: a major oral disease entity. J Prosthet Dent. 1971 Sep;26(3):266-79. doi: 10.1016/0022-3913(71)90069-2. No abstract available.
- Background: PubMed 5284182Atwood DA, Coy WA. Clinical, cephalometric, and densitometric study of reduction of residual ridges. J Prosthet Dent. 1971 Sep;26(3):280-95. doi: 10.1016/0022-3913(71)90070-9. No abstract available.
- Background: PubMed 2040665Caldwell J, Palsson BO, Locey B, Emerson SG. Culture perfusion schedules influence the metabolic activity and granulocyte-macrophage colony-stimulating factor production rates of human bone marrow stromal cells. J Cell Physiol. 1991 May;147(2):344-53. doi: 10.1002/jcp.1041470221.
- Background: PubMed 15842256Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
- Background: PubMed 12956657Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.
- Background: PubMed 3788488Carlsson L, Rostlund T, Albrektsson B, Albrektsson T, Branemark PI. Osseointegration of titanium implants. Acta Orthop Scand. 1986 Aug;57(4):285-9. doi: 10.3109/17453678608994393.
- Background: PubMed 9118278Cochran D. Implant therapy I. Ann Periodontol. 1996 Nov;1(1):707-91. doi: 10.1902/annals.1996.1.1.707. No abstract available.
- Background: PubMed 10725391Colter DC, Class R, DiGirolamo CM, Prockop DJ. Rapid expansion of recycling stem cells in cultures of plastic-adherent cells from human bone marrow. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3213-8. doi: 10.1073/pnas.97.7.3213.
- Background: PubMed 16161734De Kok IJ, Drapeau SJ, Young R, Cooper LF. Evaluation of mesenchymal stem cells following implantation in alveolar sockets: a canine safety study. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):511-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darnell Kaigler, DDS, MS, PhD principal investigator
University of Michigan Department of Periodontics and Oral Medicine
William V Giannobile, DDS, DMedSc study chair
University of Michigan Center for Oral Health Research
Steven Goldstein, PhD study chair
University of Michigan Henry Ruppenthal Family Professor of Orthopaedic Surgery and Bioengineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tissue Repair Cells (TRC) in people with Alveolar Bone Loss, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Regeneration (time frame: 12 months after tooth extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00755911, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.