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| Name | Class |
|---|---|
| Vericel Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue Repair Cells (TRC) | Experimental | Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier |
|
| Control | Sham Comparator | Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 12 months after tooth extraction |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after tooth extraction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Center for Oral Health Research | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7246093 | Background | 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. | |
| 2680652 | Background | Albrektsson T, Lekholm U. Osseointegration: current state of the art. Dent Clin North Am. 1989 Oct;33(4):537-54. |
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Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier |
| FG001 | Control | Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier |
| BG001 | Control | Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| Posted | Mean | Standard Deviation | % bone height | 12 months after tooth extraction |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Tissue Repair Cell (TRC) | Subjects will receive TRC therapy plus Gelfoam carrier |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach Ulcer | Surgical and medical procedures | Non-systematic Assessment | Hospitalized for 19 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soreness following aspiration | Surgical and medical procedures | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darnell Kaigler | University of Michigan | 734-998-1468 | dkaigler@umich.edu |
Not provided
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
Not provided
Not provided
| ID | Term |
|---|---|
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
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|
| Control | Device | Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction |
|
|
| 5251474 | Background | Amler 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. |
| 4934947 | Background | Atwood 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. |
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| 10949835 | Background | Jeffcoat MK, Reddy MS. Advances in measurements of periodontal bone and attachment loss. Monogr Oral Sci. 2000;17:56-72. doi: 10.1159/000061636. |
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| 8493529 | Background | Langer R, Vacanti JP. Tissue engineering. Science. 1993 May 14;260(5110):920-6. doi: 10.1126/science.8493529. |
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| 2597401 | Background | Misch CE. Bone classification, training keys to implant success. Dent Today. 1989 May;8(4):39-44. No abstract available. |
| 16332231 | Background | Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205. |
| 10745268 | Background | Pecora AL, Stiff P, Jennis A, Goldberg S, Rosenbluth R, Price P, Goltry KL, Douville J, Armstrong RD, Smith AK, Preti RA. Prompt and durable engraftment in two older adult patients with high risk chronic myelogenous leukemia (CML) using ex vivo expanded and unmanipulated unrelated umbilical cord blood. Bone Marrow Transplant. 2000 Apr;25(7):797-9. doi: 10.1038/sj.bmt.1702222. |
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| 1862099 | Background | Schwartz RM, Palsson BO, Emerson SG. Rapid medium perfusion rate significantly increases the productivity and longevity of human bone marrow cultures. Proc Natl Acad Sci U S A. 1991 Aug 1;88(15):6760-4. doi: 10.1073/pnas.88.15.6760. |
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| 14661708 | Background | Stanford CM. Bone quantity and quality: are they relevant predictors of implant outcomes? Int J Prosthodont. 2003;16 Suppl:43-5; discussion 47-51. No abstract available. |
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| 22776413 | Derived | Kaigler D, Pagni G, Park CH, Braun TM, Holman LA, Yi E, Tarle SA, Bartel RL, Giannobile WV. Stem cell therapy for craniofacial bone regeneration: a randomized, controlled feasibility trial. Cell Transplant. 2013;22(5):767-77. doi: 10.3727/096368912X652968. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control |
Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. |
|
|
| Secondary | 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 | Posted | Number | participants | 12 months after tooth extraction |
|
|
|
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | Sham Comparator: Control | Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. | 3 | 12 | 11 | 12 |
|
| Assault injury | Injury, poisoning and procedural complications | Systematic Assessment | Hospitalized for 2-3 days. |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | Hospitalized 3 days |
|
| Anxiety prior to procedure | Social circumstances | Non-systematic Assessment |
|
| Post extraction soreness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pulled leg muscle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fractured tooth | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Discomfort near surgical site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Restoration defect | Surgical and medical procedures | Non-systematic Assessment |
|
| Upper lip tingling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Oral conidition requiring multiple extractions | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fractured tooth | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Post surgical infection | Infections and infestations | Non-systematic Assessment |
|
| Infection | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Shingles | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Flu | General disorders | Non-systematic Assessment |
|
| Dislocated knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Swelling and tenderness in tooth extraction area | Surgical and medical procedures | Non-systematic Assessment |
|
| Fractured tooth extracted | Surgical and medical procedures | Non-systematic Assessment |
|
| Sensitive tooth | Nervous system disorders | Non-systematic Assessment |
|
| Post extraction pain | Surgical and medical procedures | Non-systematic Assessment |
|
| Open incision due to sutures coming out | Surgical and medical procedures | Non-systematic Assessment |
|
| Discomfort with mouth movement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Slight incision opening | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Slight incision opening | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pressure in sinus following extraction | Surgical and medical procedures | Non-systematic Assessment |
|
| Fractured teeth extracted | Surgical and medical procedures | Non-systematic Assessment |
|
| Non-restorable tooth extracted | Surgical and medical procedures | Non-systematic Assessment |
|
| Distress from theft | Nervous system disorders | Non-systematic Assessment |
|
| Swelling and oozing following extraction | Surgical and medical procedures | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Slight incision opening | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Discomfort | Surgical and medical procedures | Non-systematic Assessment |
|
| Fractured tooth extracted | Surgical and medical procedures | Non-systematic Assessment |
|
| Slight incision opening | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Non-restorable tooth extracted | Surgical and medical procedures | Non-systematic Assessment |
|
| Implant cover screw fell out and was replaced | Surgical and medical procedures | Non-systematic Assessment |
|
| Fractured tooth extracted | Surgical and medical procedures | Non-systematic Assessment |
|
| Failed aspiration | Surgical and medical procedures | Non-systematic Assessment |
|
| Bruising aspiration site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Moderate-severe swelling following extraction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Mild swelling and bruising following extraction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fractured tooth | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-restorable teeth extracted | Surgical and medical procedures | Non-systematic Assessment |
|
| Moderate bruising and swelling following implant uncovery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Supporation from tip of nose | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Crown fell off | Surgical and medical procedures | Non-systematic Assessment |
|
| Broken upper flipper | Surgical and medical procedures | Non-systematic Assessment |
|
| Cut tendon in hand | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fell down stairs and tore tendons in right foot | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post-op bleeding at aspiration site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Relocated to another state due to personal issues | Social circumstances | Non-systematic Assessment |
|
| Implant cover screw fell out | Surgical and medical procedures | Non-systematic Assessment |
|
| Pink eye | Eye disorders | Non-systematic Assessment |
|
| Bruising following extraction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fractured tooth | Surgical and medical procedures | Non-systematic Assessment |
|
| Tissue near extaction site loose causing some tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Soreness in extraction site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Choking while eating | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Acute pharyngitis | Blood and lymphatic system disorders | Non-systematic Assessment | PCP |
|
| Strep throat | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Swelling following extraction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bruising following extraction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Discomfort following implant uncovery | Surgical and medical procedures | Non-systematic Assessment |
|
| Post-op bleeding at aspiration site | Surgical and medical procedures | Non-systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Post-op bleeding at aspiration site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bruising and swelling following extraction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bone exposure following extraction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | non-study area |
|
| Sensitivity to sweet and cold | Nervous system disorders | Non-systematic Assessment |
|
| Swelling following extraction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nausea from medication | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain and leg cramping during aspiration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fractured teeth extracted | Surgical and medical procedures | Systematic Assessment |
|
| Surgical treatment for addiction | Surgical and medical procedures | Systematic Assessment |
|
| Crown fell off | Surgical and medical procedures | Systematic Assessment |
|
| Broken flipper | Surgical and medical procedures | Systematic Assessment |
|
| Acute pharyngitis | General disorders | Systematic Assessment | ER |
|
| Density in lungs | General disorders | Systematic Assessment |
|
| Failed aspiration | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |