UnknownPhase 1/2

Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs

Russia12 participantsStarted 2014-09

Plain-language summary

Autologous MMSCs will be isolated from oral mucosa biopsy sample and expanded in vitro.Tissue engineered construction will be created using synthetic tricalcium phosphate and autologous MMSCs. Patients will undergo sinus lift procedure with implantation of created tissue-engineered construction. This is a single arm study with no control. All patients receive cell therapy.

Who can participate

Age range

20 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: * Partially edentulous maxilla * Height of the bone tissue in the area of reconstruction 1 - 5 mm according to results of cone-beam computed tomography * Minimal height of the augmentation - 8 mm * Volume of bone tissue deficiency of the alveolar process of the maxilla 3 - 5 cm3 * Implant installation scheduled to be at least 6 months after sinus-lift operation * Patient is familiar with Participant information sheet * Patient signed informed consent form Non-inclusion Criteria: * Chronic and acute ear, nose and throat diseases, including maxillary sinusitis, foreign bodies in the maxillary sinus, odontogenic and not odontogenic maxillary sinus cyst * Medical history of surgery on maxillary sinuses during preceding 6 months prior to implantation of tissue engineered construction * Progressive somatic disease (clinically significant diseases of the cardiovascular, hematopoietic or endocrine system, systemic diseases, immunopathological states) * Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy * Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.) * Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology * Patient prescribed for any medications with proven effect on bone metabolism * Diabetes mellitus, disorders of thyroid and parathyroid glands * Clinically significant abnormalities in results of laboratory t…

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

Number of serious adverse events (SAEs) and serious adverse reactions (SARs)

Timeframe: 1 week after treatment

Trial details

NCT IDNCT02209311

SponsorCentral Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Partially Edentulous Maxilla trials