Cleft PalatePhase 1/2NCT01616953
Cell Therapy for Craniofacial Bone Defects
A Phase 1/2 study testing Ixmyelocel-T and Autogenous Bone Grafting in people with Cleft Palate and Trauma, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate, Trauma
- What is being tested?
- Ixmyelocel-T and Autogenous Bone Grafting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2015
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
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.
Read the 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)
- Conditions
- Cleft Palate, Trauma
- Being tested
- Ixmyelocel-T, Autogenous Bone Grafting
- Keywords
- dental implants
- Medical subject headings
- Cleft Palate, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixmyelocel-TBiological
Also called bone repair cells
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)
Autogenous Bone GraftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ixmyelocel-T | Experimental | 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. Receives: Biological: Ixmyelocel-T |
| Autogenous Bone Grafting | Active comparator | 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. Receives: Procedure: Autogenous Bone Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Regeneration
The primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.
Measured: 4 months
Secondary outcomes (1)
Implant Stabilization
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionJun 2015
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.
- Other trials for Cleft PalateStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darnell Kaigler, University of Michigan
- Investigators
- Darnell Kaigler, DDS, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616953
- Sponsor's protocol ID
- HUM00060042
- Status last verified
- Mar 2017
- First submitted
- 8 Jun 2012
- Last updated
- 4 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Therapy for Craniofacial Bone Defects
- ClinicalTrials.gov ID
- NCT01616953
- Acronym / sponsor ID
- HUM00060042
- Conditions
- Cleft Palate, Trauma
- Keywords
- dental implants
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 4 May 2017
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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixmyelocel-T | Experimental | Biological: Ixmyelocel-Tiliac 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. |
| Autogenous Bone Grafting | Active comparator | Procedure: Autogenous Bone GraftingAlveolar 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (23 listed)
- 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.
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 |
|---|---|---|
| Ixmyelocel-TAlso: bone repair cellsTwelve 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) | Biological | Ixmyelocel-T |
| Autogenous Bone GraftingAlveolar 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 or surgery | Autogenous Bone Grafting |
Primary outcome
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.
1 secondary outcome
Implant Stabilization
Time frame: 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cleft Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Not yet recruiting
Furlow With Buccinator and Fistula Formation
Cleft Palate
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
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, PhD principal investigator
University of Michigan
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 Ixmyelocel-T and Autogenous Bone Grafting in people with Cleft Palate and Trauma, 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 14 inclusion and 23 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 4 May 2017. 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. 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 4 May 2017). 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: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2017.