JPRN-jRCTb030190134
Recruiting
Phase 1
Treatment of temporomandibular joint disorder using autologous adipose-derived stem cells (AUASC-TKY2017) - Treatment of TMJ disorder using autologous ADSCs (AUASC-TKY2017)
Hoshi Kazuto0 sites3 target enrollmentNovember 14, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Refractory emporomandibular joint disorder with the symptoms of osteoarthritis (pain and/or trismus)
- Sponsor
- Hoshi Kazuto
- Enrollment
- 3
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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\.
Outcomes
Primary Outcomes
Not specified
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