Treatment of TMJ disorder using autologous ADSCs (AUASC-TKY2017)
- Conditions
- Refractory emporomandibular joint disorder with the symptoms of osteoarthritis (pain and/or trismus)
- Registration Number
- JPRN-jRCTb030190134
- Lead Sponsor
- Hoshi Kazuto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
Patients fulfilling all criteria listed below are included.
1) Patients who were diagnosed as temporomandibular joint disorder with the symptoms of osteoarthritis (pain and/or trismus), and without complete pain relief after joint lavage (at least once) or conservative treatment for more than 1 month.
2) Patients who are 20 years old or more, and younger than 75 years old. (at the time of agreement with participation in this study)
3) Patients who can obey the schedule for observation and examination prescribed in the protocol.
4) Patients who can understand the contents of this study and provide informed consent by documents.
5) Patients with good physical conditions enough to enable observation as outpatients after enrollment.
Patients meeting at least one of the criterion listed below are excluded.
1) Patients with ASA physical status III or worse.
2) Patients with severe diseases related to adipose tissues such as lipoatrophy.
3) Patients with malignant diseases or suspicions of them.
4) Patients with uncontrolled diabates (HbA1c 7.0 % or more).
5) Patients with suspicions of sepsis.
6) Patients with relapsing infections around temporomandibular joints.
7) Patients with histories of surgical treatments in 1 year before this treatment or scheduled to receive surgeries within 6 months after this treatment at temporomandibular joints.
8) Patients who received joint lavages or intraarticular injections with local anesthetics, hyaluronic acid or cell processing products within 1 month before the screeing examinations.
9) Patients unable to discontinue class III antiarrhythmic agents (i.e. amiodarone) from the begining of screening examinations to the time of the injection of AUASC-TKY2017.
10) Patients who received intraarticular injections or systemic administrations of adrenal corticosteroids within 1 month before the screeing examinations (excluding external medications).
11) Patients who are scheduled to, or likely to receive dental cares with wide opening of mouths in 2 months after the injection of AUASC-TKY2017.
12) Female paritens who are pregnant, suspected to being pregnant, breast-feeding, or unable to agree with birth controlling until 6 months after the injection of AUASC-TKY2017.
13) Patients suspected of syphilis, hepatitis B or C, HIV infection or adult T-cell leukemia.
14) Patients with histries of anaphylaxis.
15) Patients with hypersensities or allergies to lidocaine, or suspected of it.
16) Patiens who have been enrolled in other clinical studies or clinical trials within 90 days before providing informed consent.
17) Patients with mental diseases unable to fill in survey sheets adequately.
18) Patients who are judged to be inadequate for this study by a principal investigator or sub-investigators for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method