Phase 1/2 Chondrogen Data

Chondrogen is currently being evaluated in clinical trials for regeneration of the meniscus and prevention of osteoarthritis in the knee. The meniscus is a crescent-shaped cushion in the knee that helps provide stability to the joint. Injury and tears to the meniscus are common, arising from trauma or age.

Our clinical research demonstrates that an injection of Chondrogen in patients with osteoarthritis significantly reduces pain and the likelihood of degenerative bone changes associated with osteoarthritis (OA) is also reduced. Two different dose levels of Chondrogen were evaluated in the Phase I/II trial. Pain scores improved from six months to one year following treatment, suggesting Chondrogen caused a biological modification of OA.

Chondrogen Clinical Trial for the Treatment of Knee Injuries

This Phase 1/2 study has completed enrollment

In this trial, patients received an injection into their knee of stem cells or placebo one week after surgery along with standard post-surgical treatment. The recovery process was then closely monitored by the orthopedic surgeon using state of the art techniques such as MRI.

Trial Overview

A total of 55 patients were enrolled in the trial. Male and female patients were eligible and must have been between the ages of 18 and 60, otherwise healthy, and required removal of at least 50% of the injured portion of the medial meniscus to treat meniscal tears and/or degeneration. Treatment was administered shortly after surgery, so patients who had already undergone meniscectomy surgery were not eligible. Patients with significant articular cartilage damage or degeneration were ineligible.

Trial Highlights

Trial Design

  • 55 patient, randomized, double-blind, placebo controlled
  • Adults from 18-60 years of age
  • Patients received an intra-articular injection of Chondrogen one week post medial meniscectomy

Efficacy Results

  • Significant improvement in pain at 6 weeks, 6 months, and 12 months as compared to placebo in OA patients
  • The effects were dose dependent
  • Patients receiving the control were more likely to experience degenerative bone changes associated with OA
  • Pain scores improved from six months to one year following treatment, possibly indicating a biological modification of OA

Safety Results

  • Chondrogen was well tolerated at both dose levels

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