About this trial
This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It contains two parts dose-escalating, and blind random study in adult KOA subjects.
Eligibility criteria
Qualifiers
Subjects who understand and voluntarily sign the Informed Consent Form(ICF) before the enrolment;
Age: 40-65 years old, both genders;
Diagnosis of knee osteoarthritis based on American College of Rheumatology criteria;
Subjects with KOA who have persistent pain for more than six months
Disqualifiers
Subjects previously diagnosed of secondary knee osteoarthritis, or those diagnosed with hip/ankle joint disease requiring medical intervention;
Suffering from other diseases that impair knee function or joints;
Have received stem cell therapy;
Have knee injury history;
Trial design
Treatments tested in this trial
- NCR100
- 0.9% Normal saline
Treatment groups
Locations
Sponsors and collaborators
Nuwacell Biotechnologies Co., Ltd.
Lead sponsor
Shanghai 6th People's Hospital
Collaborator