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Clinical Trials/JPRN-jRCTb030190134
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.

Registry
who.int
Start Date
November 14, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hoshi Kazuto

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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