Context: Injection with homologously-used umbilical cord tissue allograft has not been adequately studied in patients suffering from knee pain.
Objectives: The goal of this study is to determine if knee pain subjects who received cryopreserved umbilical cord tissue (UCT) injected into knee joints experience less knee pain, better function, decreased physical limitations, and reduction of medications (e.g., opiates, NSAIDs, and acetaminophen) over a 6-month period.
Methods: Prior to initiation of this study, Institutional Review Board (IRB) approval was obtained. Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritic Index (WOMAC), and medication usage data were recorded for thirty (30) consenting knee pain subjects receiving UCT at a single site in the United States. Subject profile information was also gathered and utilized to gain further insight into any effects of age, gender, and BMI on pain improvement over time.
Results: Mean resting VAS scores improved from 1.95 to 0.83 over 6 months (p<0.001), while mean VAS scores with activity improved from 6.28 to 2.87 (p<0.001) for the same period. There was no strong evidence of correlation found between gender and VAS scores (resting or with activity). However, there were statistically significant correlations found for both BMI vs. Pre-injection VAS with activity scores (r=0.402, p=.028) and Age vs. Pre-injection VAS with activity scores (r=0.434, p=.017).
Mean WOMAC daily activity function scores improved from 44.7 to 18.5 over the same 6 months (p<.001).
Overall, of the patients who used medications at the beginning of the study (18), 77.8% of them reduced or eliminated medication use.
Conclusion: Analysis demonstrates that injection with UCT decreases pain, improves physical function, and allows for less medication use for at least 6 months.