Cell Therapy for Craniofacial Bone Defects

NCT01616953 | Completed Phase 1 Results

• 1 other identifier: HUM00060042
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cleft Palate; Trauma

Keywords

dental implants

Outcome Measures

Primary Outcomes (1)

• Bone Regeneration

  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 Outcomes (1)

• Implant Stabilization

  10 months

Study Arms (2)

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.

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.

Procedure: Autogenous Bone Grafting

Interventions

Ixmyelocel-T BIOLOGICAL

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)

Also known as: bone repair cells

Ixmyelocel-T

Autogenous Bone Grafting PROCEDURE

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.

Autogenous Bone Grafting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Cleft Palate; Wounds and Injuries

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Darnell Kaigler
• Organization: University of Michigan

dkaigler@umich.edu

734-615-4023

Study Officials

• Darnell Kaigler, DDS, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 4, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-03

Locations

US (1)