NCT04519047

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• PRP
• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	PRP	Beginning on treatment period, subjects will receive either Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4).

Timeline

• Start date: 2020-08-13
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2020-08-19
• Last updated: 2020-08-24

Locations

1 site across 1 country: Taiwan