Chondrogen Clinical Trial Information for the Treatment of knee injuries

This Phase I/II 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.

The objective of this Phase I/II study was to evaluate the safety and efficacy of Chondrogen for meniscal regeneration following partial meniscectomy surgery.

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 have already undergone meniscectomy surgery were not eligible. Patients with significant articular cartilage damage or degeneration were ineligible.

Trial Highlights

• About 30% of patients treated with Chondrogen demonstrated an improvement in their baseline cartilage or joint condition, while no patients in the placebo group demonstrated similar improvement
• Administration of Chondrogen was found to be well tolerated
• Chondrogen was not associated with serious adverse events and did not result in any adverse hematological events
• Chondrogen did not result in the formation of any unwanted or ectopic tissue

Click here to read more about the Phase I/II results.

If you have questions about this study, please email us at Chondrogen@Osiris.com