JPRN-jRCTb030190134招募中1 期
Treatment of temporomandibular joint disorder using autologous adipose-derived stem cells (AUASC-TKY2017) - Treatment of TMJ disorder using autologous ADSCs (AUASC-TKY2017)
Hoshi Kazuto0 个研究点目标入组 3 人开始时间: 2019年11月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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