Objectives: The purpose is to report preliminary data on clinical response to dehydrated cell and protein concentrate (dCPC) versus corticosteroid (CSI). Design: A single-site prospective, randomized controlled single-blinded trial of patients with knee osteoarthritis. Methods: Pain and function were assessed using a visual analog scale (VAS), the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Emory Quality of Life (EQOL) measure at 1, 2, 3, 6, 9 and 12 months. Results: 51 patients were enrolled at the time of analysis (27 dCPC, 24 CSI). Both groups demonstrated improvement on the VAS, KOOS and EQOL. Largest differences were observed at 2 (p = 0.05), 3 (p = 0.012) and 6 months (p < 0.001) with a decrease of 1.66 in VAS at 6 months for dCPC (95% CI: -2.67 to -0.65) and 1.34 (95% CI: -2.37 to -0.3) for CSI. Time-averaged measures showed no difference between groups (p = 0.20). Limited data at 9 and 12 months trended toward improvement in the dCPC group. Conclusion: dCPC products may be used as a treatment for knee osteoarthritis. Larger trials are warranted. Clinical Trial Registration: NCT03710005 (ClinicalTrials.gov).
Keywords: amniotic/placental stem cells; birth tissue product; bone and cartilage; knee osteoarthritis; mesenchymal stem cells; orthobiologics; stem cells.
The purpose of this study was to discuss preliminary data from a clinical trial comparing a single injection of an amniotic-derived tissue product (dehydrated cell and protein concentrate [dCPC]) to corticosteroid for the treatment of knee osteoarthritis. The study took place at a single institution. 51 patients were enrolled at the time of analysis (27 dCPC, 24 corticosteroid). Both groups demonstrated improvement in pain and function 6 months after treatment. There was a larger improvement in the amniotic-derived tissue product group, but this did not reach a level of statistical significance. There were limited data beyond 6 months, but this trended toward a continued improvement in the amniotic-derived tissue product group. Findings suggest that these amniotic derived tissue products may be used as a treatment for knee osteoarthritis, but larger studies are needed.