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Clinical Trials/JPRN-jRCT2021200034
JPRN-jRCT2021200034
Completed
Phase 2

Investigator-initiated Phase 2 clinical study of S-005151 in patients with osteoarthritis of the knee

Ishibashi Yasuyuki0 sites20 target enrollmentDecember 24, 2020
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ConditionsOsteoarthritis of the knee

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Osteoarthritis of the knee
Sponsor
Ishibashi Yasuyuki
Enrollment
20
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 24, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ishibashi Yasuyuki

Eligibility Criteria

Inclusion Criteria

  • •\[At the time of informed consent]
  • •1\) Patients with the ability to understand the study and comply with such as the requirements of the study, and to obtain written consent prior to screening.
  • •2\) Male or female patients aged \>\=20 and \<70 at the time of consent acquisition.
  • •3\) Patients with medial knee osteoarthritis scheduled for high tibial osteotomy and arthroscopic microfracture.
  • •4\) (Only women) Patients who can be consent to the contraceptive methods during the period from consent acquisition to 3 months after the last administration .
  • •\[Before surgery]
  • •5\) Patient with Medial knee osteoarthritis condition meeting the following for knee joints undergoing surgery.
  • •\-Kellgren\-Lawrence grade is 2 or 3
  • •\-Exposure of subchondral bone is seen partially or the whole articular surface
  • •\-Area of the cartilage defect is 2 \~ 9 cm^2

Exclusion Criteria

  • •\[At the time of informed consent]
  • •1\) Patients with the following diseases in the knee joint of the surgical treatment side specified in this study.
  • •A) Anterior cruciate ligament dysfunction, Posterior cruciate ligament dysfunction
  • •B) Arthritis of the knee (purulent arthritis, gouty arthritis)
  • •C) Lateral tibiofemoral arthropathy, patellofemoral arthropathy, and neuropathic arthropathy (Charcot's joint)
  • •D) Medial femoral condyle osteonecrosis
  • •E) Intra\-articular fracture of the knee articular with residual sequelae during or after treatment
  • •F) Fractures of the femur or tibia under treatment.
  • •2\) Patients with concomitant systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, various types of vasculitis).
  • •3\) Diabetics with poor control (HbA1C more than 8% in laboratory tests of pre\-test 1\).

Outcomes

Primary Outcomes

Not specified

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