The Use of Human Mesenchymal Stem Cell Technology for Treatment of Mandibular Osteoradionecrosis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-007986
Sponsor Protocol Number: 13-007986
About this study
We are currently working on a research project to investigate the use of stem cells to regenerate bone in the jaw that is unhealthy as a result of osteoradionecrosis (ORN). Stem cells have the capability to develop into bone, cartilage, fat, skin or blood vessels, and are thought to be involved in the healing process. Using your discarded jawbone (if this is being removed) and/or fat, we can generate stem cells and see if they can heal the bone in the laboratory setting. If this proves successful, we may be able to use this technology in patients to avoid extensive surgery.
In order to test this idea, the segment of your jawbone (if this is being removed) and/or fat which is routinely discarded as waste will be sent for testing. Our goal is generate stem cells for replacement of bone from patients suffering from this disease.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
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Manidbular bone, as well as fat (from the neck and donor site) , will be harvested in any patient undergoing manidbular reconstruction for osteoradionecrosis
OR
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Fat (from the neck and donor site) will be harvested from any patient undergoing tumor ablation and subsequent reconstruction with a prior history of head and neck irradiation
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jeffrey Janus, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available