Intraarticular injections of re-cultured synovial stem cells for osteoarthritis of the knee

JRCT ID: jRCTb030240359

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: osteoarthritis of the knee
• Date of first enrollment: 30/09/2024
• Target sample size: 1
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intraarticular injections of synovial stem cells

Outcome(s)

• Primary Outcome: Incidence of serious adverse events (SAEs) and significant failures from obtaining consent to 30 weeks post-dose or early discontinuation
• Secondary Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm score, numerical rating scale (NRS), X-ray examination, MRI 3D analysis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who participated in "a single-center, double-blind, placebo-controlled, randomized, parallel-group study to evaluate the efficacy and safety of Intraarticular injections of autologous synovial stem cells for knee osteoarthritis (Investigator initiated clinical trial) (Autologous synovial MSC injection into the OA knee)"
2) Patients who were eligible for both shipping inspection and confirmation inspection below
- Sterility test
- Mycoplasma negative test
- Endotoxin test
3) Patients for whom transplantation of autologous synovial stem cell products could not be carried out due to nonconformity for following inspections
- Cell number, viable cell ratio
- Cell purity evaluation
- ECM production ability

Exclude criteria

1) Patients with active infection
2) Patients diagnosed or suspected as malignant tumor in these 5 years.
3) Patient with poor controlled diabetes
4) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study
5) Patient for whom doctors decide as not appropriate to participate in the clinical study

Related Information

• Primary Sponsor: Sekiya Ichiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)