Intraarticular injections of synovial stem cells for osteoarthritis of the knee

Phase 1

• Conditions: osteoarthritis

• Registration Number: JPRN-UMIN000026732
• Lead Sponsor: Medical Hospital of Tokyo Medical and Dental University

Brief Summary

Fully automatic 3D MRI analysis showed that synovial MSC injections suppressed cartilage loss in the knees of patients with progressive OA.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-01
• Study Completion: 2020-03-10
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients whose reduction of cartilage area ratio is not greater than 2% from week -30 to week -15 2) Patients who is unidentified 3) Patients who underwent surgery or arthroscopic examination in the affected knee 4) Patients whose clinical symptoms have been sufficiently improved by conservative treatments in the last 3 months 5) Patients with a catching sensation in the knee 6) Patients with knee instability 7) Patients with a history of trauma in the knee 8) Patients for whom MRI is not indicated because of claustrophobia and so on 9) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months 10) Patients with active infection 11) Patients diagnosed or suspected as malignant tumor in these 5 years 12) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B) 13) Patients sensitive to animal (bovine) origin materials 14) Patients with poor controlled diabetes 15) Patients with a pacemaker 16) Patients with poor general condition 17) Patients with difficulties in self-determination because of dementia and so on 18) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study 19) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product 20) Patients for whom doctors decide as not appropriate to participate in the clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Safety Adverse events and treatment-emergent adverse event 2) Efficacy Change in cartilage area ratio calculated with MRI 3D analysis at 30 weeks after injection of stem cells from baseline

Secondary Outcome Measures

Name	Time	Method
Efficacy Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm score, numerical rating scale (NRS), X-ray examination, MRI 3D analysis (meniscal thickness, width, and area ratio)