IA Injection of Rejoint Gel and PRP in Patients With Unilateral Knee OA

Knee Osteoarthritis Clinical Trial

Official title: A Randomized, Double-blind, Feasibility Study to Evaluate the Safety and Potential for Effectiveness of Intra-articular Injection of Rejoint Gel After Platelet-rich Plasma Administration in Patients With Unilateral Knee Osteoarthritis

Status Recruiting

Clinical Trial Summary

To assess the safety and tolerability of intra-articular Injection doses of Rejoint Gel after platelet-rich plasma administration in unilateral knee OA subjects.

Clinical Trial Description

This single-center, randomized, double-blind, feasibility study to evaluate the safety and potential for effectiveness of an intraarticular Injection of Rejoint Gel after platelet-rich plasma administration in patient with single knee OA, parallel-design study will enroll approximately eligible 30 subjects with single knee OA.

The subjects will be randomized (1:1) to receive 1 of 2 treatments below:

1. Treatment Group: Rejoint Gel, intra-articular injection, with platelet-rich plasma (PRP) in 2:1 volume ratio or

2. Control Group: Normal saline, intra-articular injection with PRP in 2:1 volume ratio Beginning on treatment period, subjects will receive a single treatment cycle of either 150 mg/ml Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4). Subjects will be followed to Visit 5, 6 and 7 for safety and potential for effectiveness assessments. ;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• PRP

• NCT number: NCT04519047
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Chueh-Hung Wu, MD, PhD
• Phone: +886223123456
• Email: nojred@gmail.com
• Status: Recruiting
• Phase: Phase 1
• Start date: August 13, 2020
• Completion date: December 31, 2021