CompletedPhase 1/2

Cell Therapy for Craniofacial Bone Defects

United States18 participantsStarted 2012-08

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bone Regeneration

Timeframe: 4 months

Trial details

NCT IDNCT01616953

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2017-03-23

View on ClinicalTrials.gov More Cleft Palate trials