A Study of NCR100 Injection for the Treatment of Knee Osteoarthritis( KOA)

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-65
SponsorNuwacell Biotechnologies Co., Ltd.

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

162 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Nuwacell Biotechnologies Co., Ltd.

Lead sponsor

Shanghai 6th People's Hospital

Collaborator