- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616953
Cell Therapy for Craniofacial Bone Defects
March 23, 2017 updated by: Darnell Kaigler, University of Michigan
The purpose of this research is to determine if a patient's own bone marrow tissue can help regenerate bone in the area of the jaw where an implant will be placed.
The name of the process is called Bone Repair Cell (BRC) Therapy.
A sample of bone marrow tissue will be collected and sent to a laboratory where it will be processed to form more cells.
These new cells will then be transplanted in the regenerative site.
The researchers are testing to see if these cells (BRC) will help form bone.
The research will also determine if the implant will be more stable in the area with new bone growth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Up to 20 (twenty) subjects who have alveolar defects secondary to clefts (n=10) or trauma (n=10), will be selected to participate in this study.
Among the 20 patients, a total of up to 60 defect sites will be evaluated for bone regeneration following therapy, with each subject being evaluated in from one to four sites.
Once enrolled, subjects from each of the two groups (cleft or trauma) will be randomly assigned to receive one of two possible treatments, traditional autogenous bone grafting or cell therapy (ixmyelocel-T)
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Michigan Center for Oral Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age range: 18 to 60 yrs
- 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 for
Missing tooth criteria:
Patients missing at least one maxillary lateral incisor secondary to cleft lip and/or palate:
- with compromised bone support for installation of dental implant(s) ( > 3 mm deficiency in horizontal and/or vertical bone height)
- with adequate interdental arch space for dental implant restorations
- with bony continuity between cleft segments
- with adequate interproximal space (between adjacent teeth) for dental implant installation
Patients missing multiple (1-4 teeth) teeth secondary to trauma:
- in maxillary or mandibular anterior segments (second premolar to second premolar)
- with compromised bone support for installation of dental implant(s) ( > 3 mm deficiency in horizontal and/or vertical bone height)
- with adequate interdental arch space for dental implant restorations
Exclusion Criteria:
- Allergies or hypersensitivities to study related medications: dexamethasone, chlorhexidine, ibuprofen. For patients allergic to amoxicillin a comparable substitute antibiotic will be used.
- Hematologic disorders/ blood dyscrasias. Patients will have blood drawn for a complete blood count (CBC) test. Current University of Michigan Health System normal lab values are as follows: white blood count (WBC: 4.0-10.0 x103/cmm), red blood count (RBC: male 4.50-5.90 x103/cmm; female 3.90-5.30x103/cmm), hemoglobin (HgB: male 13-17.3gm/dl; female 12-16gm/dl), Hct (male 39-50.2%; female 35-48%), mean corpuscular volume (MCV: 80-100fl), mean corpuscular hemoglobin (MCH: 25-35 pg), mean corpuscular hemoglobin concentration (MCHC: 30-37%), red cell distribution width (RDW: 11.5-15.5%), Plt (150-450x103/cmm).
- Active infectious disease
- Liver or kidney dysfunction/failure- Patients will have blood drawn for serum laboratory tests, including creatinine, blood urea nitrogen, aspartate aminotransferase test (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)
- blood urea nitrogen (BUN: 8-20 mg/dl)
- AST (8-30 IU/L)
- ALT (7-35 IU/L)
- Bilirubin (0.2-1.2 mg/dl).
- 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.
- Potential subjects whose laboratory values fall outside the UMHS normal ranges will be required to have medical clearance from their primary care provider prior to participation.
- Endocrine disorders/dysfunctions (i.e uncontrolled Type I or II diabetes, glycosylated hemoglobin [HA1C > 7%})
- 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 standard deviation [SD]); Osteopenia = T score between -1.0 and -2.5 SD; Osteoporosis = T score at or below -2.5 SD.
- 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, 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 congenital or metabolic bone disorders
- Subjects with co-morbid conditions that would affect the study outcome or interpretation of study results will be excluded
- Subjects on significant concomitant drug therapy for systemic conditions (i.e. cardiovascular disease, renal dysfunction) will not be included in the study. Occasional short term use (7-14 days) of analgesics or common cold medication is permitted. Such use of these medications will be reviewed and recorded by the Investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ixmyelocel-T
iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation.
Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.
|
Twelve days after the bone marrow aspiration, alveolar grafting will be performed.
Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
Other Names:
|
Active Comparator: Autogenous Bone Grafting
Alveolar grafting will be performed.
Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
Alveolar grafting will be performed.
Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Regeneration
Time Frame: 4 months
|
The primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant Stabilization
Time Frame: 10 months
|
The ability of the dental implant fixtures to be loaded and remain stable for six months following implant loading (at 4 months) will be evaluated.
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Darnell Kaigler, DDS, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
June 8, 2012
First Submitted That Met QC Criteria
June 11, 2012
First Posted (Estimate)
June 12, 2012
Study Record Updates
Last Update Posted (Actual)
May 4, 2017
Last Update Submitted That Met QC Criteria
March 23, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00060042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma
-
Humacyte, Inc.Active, not recruitingTrauma | Trauma Injury | Trauma, Multiple | Trauma BluntUkraine
-
University Hospital, AngersRecruiting
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedTrauma Injury | Trauma, MultipleTurkey
-
Wonju Severance Christian HospitalNational Research Foundation of KoreaRecruitingTrauma Injury | Trauma, MultipleKorea, Republic of
-
Rabin Medical CenterIsraeli Ministry of SecurityUnknown
-
Oslo University HospitalUniversity of Oslo; Sunnaas Rehabilitation Hospital; South-Eastern Norway Regional...RecruitingTrauma Injury | Trauma, Multiple | PolytraumaNorway
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.CompletedHead Injury Trauma BluntUnited States
-
Assistance Publique - Hôpitaux de ParisFrancophone Pediatric Resuscitation and Emergency Group (GFRUP)Completed
-
Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedTrauma, Multiple | Trauma Severity Indices | Injuries, Multiple | Norway/Epidemiology | Trauma Centers/Statistics & Numerical Data
-
Fundacion Clinica Valle del LiliUniversity of Pittsburgh; Hospital Universitario del Valle Evaristo GarciaRecruitingTrauma | Trauma Injury | Trauma, MultipleColombia
Clinical Trials on Ixmyelocel-T
-
Vericel CorporationCompletedIschemic Dilated Cardiomyopathy (IDCM)United States, Canada
-
Vericel CorporationCompletedPeripheral Arterial DiseaseUnited States
-
Vericel CorporationCompletedDilated CardiomyopathyUnited States
-
Vericel CorporationCompletedDilated CardiomyopathyUnited States
-
Vericel CorporationCompletedOsteonecrosisUnited States
-
Vericel CorporationCompletedCritical Limb IschemiaUnited States
-
University of MichiganVericel CorporationCompletedAlveolar Bone LossUnited States
-
Biotronik SE & Co. KGCompletedHeart Failure | BradycardiaDenmark, Hong Kong, Austria, Germany, Belgium
-
University of California, BerkeleyUniversity of Nevada, Reno; World Bank; L'Office National de Nutrition, MadagascarRecruitingEarly Childhood DevelopmentMadagascar
-
Biotronik SE & Co. KGCompletedVentricular Fibrillation | Ventricular TachycardiaGermany, Czech Republic