Combined Intra-Articular PN HPT™ and Hyaluronic Acid: Regeneration Medicine in Knee Osteoarthritis.

Background/

Objectives

Natural-origin PN HPT™ (Polynucleotides High Purification Technology) protect and revitalize chondrocytes, synoviocytes, and cartilage with a regenerative medicine perspective following intra-articular injection. This six-month, open-label data collection aimed to validate the benefits documented in previous studies of a single intra-articular injection of a proprietary PN HPT™/HA-based medical device in improving both subjective and objective manifestations of knee osteoarthritis in real-life ambulatory patients of both genders with unilateral or bilateral knee osteoarthritis.

Methods

Efficacy and safety assessments, conducted at baseline before a single PN HPT™/HA injection and after three and six months of follow-up, included the Lequesne index and the patient-assessed Numeric Pain Rating Scale (NPRS), which focuses on pain intensity, as primary endpoints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was a secondary endpoint.

Results

After three and six months, the mean baseline Lequesne index score improved by 43.8% and 51.4%, respectively. Concurrently, the mean NPRS score improvements were 42.2% and 54.7%. Furthermore, 32% of investigators and 15.5% of treated patients deemed optimal the clinical outcomes with no clinical worsening.

Conclusions

With some limitations due to the uncontrolled design and relying on subjective rating scales only, the study confirms all previous findings about the benefits of combining PN HPT™ and HA in the same medical device for intra-articular injection in knee osteoarthritis.