Abstract posters will be displayed in the Exhibit Hall beginning on Wednesday 9/4 at 10:30am
P-095 - Evaluation of the Safety and Efficacy of Cryopreserved Human Umbilical Cord Tissue Allograft for the Supplementation of Cartilage Defects Associated with Hip Osteoarthritis: An Observational Retrospective Study
Clinical Site Coordinator Regenative Labs Pensacola, Florida
Abstract Title: Evaluation of the Safety and Efficacy of Cryopreserved Human Umbilical Cord Tissue Allograft for the Supplementation of Cartilage Defects Associated with Hip Osteoarthritis: An Observational Retrospective Study
Background: Osteoarthritis (OA) is a chronic disorder that mainly affects the synovial joints through the progressive loss of articular cartilage. People who live to the age of 85 have an overall 25% chance of developing symptomatic hip OA (1). Thus, hip OA is among the most prevalent conditions affecting older populations. Physicians attempt conservative standard-care options before a patient seeks invasive treatments. Standard patient care includes symptom management with pain treatments like acetaminophen, tramadol, and intraarticular corticosteroid injections (2). While corticosteroid injections alleviate pain, they risk the progression of cartilage damage and cannot be administered frequently, requiring a three to six-month gap between each injection (3). Platelet-rich plasma and hyaluronic acid injections can be used as alternatives to corticosteroid injections but are generally either less effective than corticosteroid injections or only effective for a subset of hip OA patients, respectively (3). Neither provides long-term pain relief or directly improves the tissue damage associated with OA. Hip arthroplasty is the next intervention, but complications include infection, foreign material and space in the wound, hematoma development, nerve injury, thromboembolic disease, femur fracture, asymmetric extremity length, re-operation, and even pulmonary embolism (4,5).
Purpose/Objectives: Wharton’s Jelly (WJ) tissue allografts are an alternative intervention that can supplement the cartilage in the hip that has deteriorated from OA. WJ is comprised of collagen fiber types I, III, and V, cytokines, proteoglycans, various growth factors, and hyaluronic acid. It is considered a noninvasive tissue transplant that can effectively promote the repair of musculoskeletal injuries. Recent literature has shown that when added to standard conservative treatments, WJ effectively improved defects in the articular cartilage of patients with knee osteoarthritis (6,7). Given the composition of WJ and its successful application in patients with connective tissue defects associated with knee osteoarthritis, this study aims to observe that WJ applied directly to the site of tissue defects via syringe in patients with hip osteoarthritis and documented cartilage damage and loss can improve patient tissue defects and quality of life.
Methods: The retrospective repository at Regenative Labs was used to identify the patients analyzed in this paper. The repository contains observational data collection of patients who provide informed consent and receive one or more applications of either their Wharton’s Jelly tissue allografts or dehydrated amniotic membrane allografts. The study cohort includes 69 patients, 48% female and 52% male. Thirteen patients received two applications based on the severity of the defect, 5 females and 8 males. The demographics identify the average age to be 74.5 years old. The average BMI was 28.8 kg.m2. A 3.5-inch spinal needle, under direct ultrasound and video fluoroscopy guidance, was injected into the hip joint. Applications of 2ml of the 75mg/ml WJ tissue allograft and Marcaine followed the verification of proper placement. A 30-minute monitoring period was conducted after each application to ensure no adverse reactions occurred. Each patient completed the Numeric Pain Rating Scale (NPRS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and a quality of life scale (QOLS) at the initial application visit, 30 days, and 90 days, post-application. Statistical significance was calculated for average scores over time as well as the minimal clinically important difference (MCID) for patients.
Results: The three tests used to analyze data were Analysis of variance (ANOVA), Tukey’s Test, and Wilcox rank-sum test. ANOVA test results suggested statistically significant changes in the mean pain scores between intervals across five of the six scales: NPRS, WOMAC, pain, stiffness, and functionality. There were no significant differences in QOLS scores for the three intervals. ANOVA test results showed no differences in age, BMI, and gender in pain scores between Initial and Day 90. A total of 13 patients received two applications to the same side, and 56 patients received one application. The Wilcoxon rank-sum test compared the differences between single and double applications. When comparing single versus double applications, there were significant differences in mean changes for NPRS, pain, and QOLS. Single and double application patients had an average change of 1.76 and 0.00 for NPRS, 3.1 and 0.2 for pain, and -3 and 5 for QOLS with p-values less than 0.05. Also, there was no difference in BMI or age between single and double applications. The BMI was averaged at 28 kg/m2 for both groups, and mean ages were 74.4 and 75 years for single and double applications, respectively.
The MCID was used to identify the minimum but meaningful differences before and after application, and the anchor-based method was used to identify the value by forming a receiver operating characteristic (ROC) curve. The anchor question can be expressed as, “How different is your pain comparing before and after the application?” After determining the changes, the patients were grouped into four categories by the range of changes in their NPRS scores. The grouped answers were “Not better,” “Slightly better,” “Better,” and “Much better." The MCID values for “Slightly better” patients are 11.14 for total WOMAC, 2.71 for pain, 1.03 for stiffness, 7.40 for functionality, and -5.40. Considering the AUC, the MCID from WOMAC and pain scales are more able to discriminate between “Slightly better” or not. About 44.9% exceeded the MCID for WOMAC, and 46.4% exceeded the MCID for pain.
Conclusions/Implications for future research and/or clinical care: WJ allografts have been shown to significantly improve self reported pain scores of patients with degenerated cartilage from hip osteoarthritis. Provided there have been no reported adverse reactions related to the tissue allografts within the span of the retrospective repositories beginning, WJ allografts should be considered as a safe regenerative medicine option for individuals suffering from tissue degeneration refractory to other standard-of-care methods. This study provides the foundation for additional research to clarify the dose, protocol, and durability of WJ allograft applications.
References:
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Davis, J. M., Sheinkop, M. B., & Barrett, T. C. (2022). Evaluation of the Efficacy of Cryopreserved Human Umbilical Cord Tissue Allografts to Augment Functional and Pain Outcome Measures in Patients with Knee Osteoarthritis: An Observa-tional Data Collection Study. Physiologia, 2(3), 109–120. https://doi.org/10.3390/physiologia2030010
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