NCT02210468

APIC-CF Therapy for Mild to Moderate Osteoarthritis of the Knee

A Phase I/II, Multicenter, Double-Blind, Placebo-controlled Safety and Efficacy Study to Evaluate APIC-CF Therapy for Mild to Moderate Primary Osteoarthritis of the Knee

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Cytonics Corporation · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The mechanism of Osteoarthritis (OA) is complex, however the investigators know that cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes, leading to proteases that break down cartilage. There is a protein in the human blood called alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage. Cytonics developed a device that use the patient's own blood to remove all cells and concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.

Conditions

• Pain
• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	APIC-CF, 4 cc
DEVICE	APIC-CF, 2 cc
OTHER	Placebo Comparator: Saline	Placebo Comparator: Saline

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2014-08-06
• Last updated: 2015-08-21

Locations

1 site across 1 country: United States