MedTrace Logo

Cell Therapy for Craniofacial Bone Defects

NCT01616953 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-05-04

Study results available
· View outcomes & findings →

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

Interventions

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)

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.

Sponsors & Collaborators

Principal Investigators

  • Darnell Kaigler, DDS, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616953 on ClinicalTrials.gov