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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Ixmyelocel-T
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:
  • bone repair cells
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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