Mitchell Sheinkop

Introduction: Knee osteoarthritis (OA) is a highly prevalent and debilitating condition with significant emotional and economic impacts. Current treatment options may only provide temporary pain relief and are not regenerative, thus the progression of knee OA is not deterred and total knee arthroplasty is inevitable. Injection therapies with orthobiologics possess regenerative potential and are an emerging treatment option. We present a prospective study aimed at examining patients with knee OA who had received an autologous platelet concentrate fluid (APCF) injection produced through a fluid volume reducer. Methods: This was an observational review of the results following an APCF injection in a cohort of patients at a single site. Patients were included in the study if they were diagnosed with K/L grade 2–3 knee OA and treated with an APCF knee injection. Patients were excluded if they had obtained an orthobiologic injection in the three months prior to study enrollment or if baseline data were unavailable. Knee score and function score were used to assess patients at the baseline and post-injection follow-ups. Results: Improvements for knee score were statistically significant for the follow-ups at three months, six months, one year, and three years. Function score improved, with statistically significant changes for the three month and three year follow-ups. Conclusions: Our study demonstrates that there is some utility in using APCF injection for knee OA, with improvements that may be sustained up to three years in some patients.

Objective: Safety and therapeutic benefit were assessed for treating knee osteoarthritis with dual intraosseous and intraarticular bone marrow concentrate injections at the two-year milestone. Participant-reported outcomes for Knee Society Score-Knee, Knee Society Score-Function, Lower Extremity Functional Scale, and Visual Analog Scale were assessed, along with Range of Motion and changes in Kellgren-Lawrence Grades. Methods: Eighteen of 22 knees injected at the start of the study survived to the two-year milestone. The study was performed prospectively at a single site with a single investigator in an open label pilot study with autologous bone marrow concentrate. Each participant received 80% of their bone marrow concentrate in the tibial plateau intraosseous, and 20% intraarticular. Results: No serious adverse events were attributed to the treatment during the two-year study. Statistically meaningful improvement in mean outcomes and range of motion from baseline to 24-months was observed. Kellgren-Lawrence scores worsened by one level for five knees (29.4%), improved by one level for three knees (17.6%) and were unchanged for nine knees (52.9%). Three study participants progressed to a total knee arthroplasty with an average time to surgery of 16.3 months following treatment. Conclusion: Safety was demonstrated for the bone marrow concentrate-combined treatment via intraosseous and intraarticular routes for treating Kellgren-Lawrence II-III knee osteoarthritis during the two-year study period. Mean changes at 24-months showed sustained improvement from baseline for range of motion, Knee Society Score-Knee, Knee Society Score-Function, and Visual Analog Scale, although the Lower Extremity Functional Score decreased by 8.8%. Most (70.5%) knees showed no change or an improvement in their Kellgren-Lawrence scores from baseline to the two-year endpoint. These results point to a potential durable benefit in pain mitigation and improved quality of life for patients with knee osteoarthritis who receive bone marrow concentrate via the intraosseous and intraarticular routes for treating knee osteoarthritis. Keywords: Bone Marrow Concentrate (BMC), Intraosseous, Intraarticular, Knee OA, VAS, LEFS, Orthobiologic, Subchondral, ROM

The primary objective of this study is to report the initial efficacy data observed with the use of cryopreserved human umbilical tissue allografts for supplementation in patients with symptomatic degeneration of load-bearing articular cartilage in the knee joint. Our primary endpoints were pain, stiffness, and functional recovery scores. In this ongoing study, 55 participants (age 56–93 years) received a single Wharton’s jelly tissue allograft application. The study dose consisted of 150 mg of Wharton’s jelly allograft suspended in approximately 2 mL of sterile sodium chloride 0.9% solution (normal saline). Each study knee application was performed under ultrasound guidance in a physician’s office. The research methodology consisted of Numeric Pain Rating Scale (NPRS) scores and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subsection scores including pain, stiffness, and physical function. Study enrollment consisted of 55 patients followed for a post-application duration of 90 days. No adverse events or adverse reactions were reported. The results demonstrated statistically significant improvements of NPRS and WOMAC in initial versus 90-day examination. The data represent Wharton’s jelly tissue allograft applications are safe, non-surgical, and efficacious for patients with symptomatic osteoarthritis of the knee.

The primary objective of this study is to report the initial efficacy data observed with the use of cryopreserved human umbilical tissue allograft for the supplementation of cartilage defects in patients with symptomatic knee osteoarthritis. Our primary endpoints were pain, stiffness, and functional recovery scores. In this ongoing study, 55 participants (age 56-93 years) received a single Wharton's jelly tissue allograft application. The study dose consisted of 150mg of Wharton's jelly allograft suspended in approximately 2mL of sterile Sodium Chloride 0.9% solution (normal saline). Each study knee application was performed under ultrasound guidance in a physician's office. The research methodology consisted of NPRS scores and WOMAC subsection scores including pain, stiffness, and physical function. Study enrollment consisted of 55 patients followed for a post-application duration of 90 days. No adverse events or adverse reactions were reported. The results demonstrated statistically significant improvements of NPRS and WOMAC in initial versus 90-day examination. The data represents Wharton's jelly tissue allograft applications are a safe, non-surgical, and efficacious for patients with symptomatic articular cartilage defects associated with osteoarthritis of the knee.

Background: Cell-based therapies have shown promise for the treatment of knee osteoarthritis (OA). The current study compared exercise therapy to autologous bone marrow concentrate (BMC) and platelet products for knee OA treatment.Methods: Patients with symptomatic knee OA (N = 48) were randomized into either an exercise therapy control group or treatment group with injection of autologous BMC and platelet products. Patients in the control group could crossover to BMC treatment after 3 months. Clinical outcomes were documented at baseline and at 6-weeks, 3, 6, 12 and 24 months, including the Knee Society Score (KSS), Pain Visual Analogue Scale, Short Form-12 Scales (SF-12), and Lower Extremity Activity Scale (LEAS).Results: All patients in the exercise group crossed over to receive BMC treatment after 3 months (N = 22 crossover). At 3 months, KSS-knee, SF-12 Physical, and LEAS improved significantly in the crossover group compared to exercise, similar to significant improvements on KSS-knee and LEAS for the treatment group (N = 26) compared to exercise group at 3 months. After BMC treatment, patients’ clinical outcome scores (except SF-12 Mental Health), were significantly improved through the 2-year follow-up compared to baseline. No serious adverse events were reported.Conclusion: The use of image-guided percutaneous BMC with platelet products yielded better results than exercise therapy as an effective alternative therapy for patients with symptomatic moderate to moderate-severe osteoarthritis of the knee.Trial registrationNCT02034032.https://clinicaltrials.gov/ct2/show/NCT02034032. Registered 13 January 2014