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

Phase 1

• Conditions: PRP; Knee Osteoarthritis
• Interventions: Biological: PRP

• Registration Number: NCT04519047
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-13
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-16
• Study First Posted: 2020-08-19
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-24
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	PRP	Saline+PRP
Rejoint	PRP	Rejoint+PRP

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse events (AEs) and serious AEs	Baseline to Visit 7 (15th week)	Adverse events (AEs) and serious AEs

Secondary Outcome Measures

Name	Time	Method
Kellgren-Lawrence grading scale	Baseline to Visit 7 (15th week)	Change in the Kellgren-Lawrence (KL) Grading Scale: 0-IV (0: normal, IV: the worst)
Western Ontario and McMaster Universities Index for osteoarthritis	Baseline to Visit 7 (15th week)	Change in Western Ontario and McMaster Universities (WOMAC) Index for osteoarthritis: five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan