WJ primarily comprises collagen and glycosaminoglycans, mirroring articular cartilage composition [19]. WJ is similar to articular cartilage in scaffold architecture and bio function, making WJ an ideal homologous allograft to supplement articular cartilage defects in patients with symptomatic knee osteoarthritis. Umbilical cord allografts have improved WOMAC scores for up to one year in patients with diffuse knee pain due to osteoarthritis [4]. When compared to HA injections, umbilical cord allografts had significantly higher WOMAC improvements [4].

In this study, we examined the effectiveness of umbilical cord tissue allografts in supplementing structural tissue defects in articular cartilage. We examined this through improved patient-reported outcomes of both the Numeric Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) values. We hypothesize that patients receiving umbilical cord allograft supplementation will show an improvement in the NPRS and WOMAC scores over a 90-day period when compared to the initial administration date.

Method:

This observational data collection study analyzed 55 adult patients who met predetermined inclusion and exclusion criteria at 12 clinics throughout the United States. Eligible patients included adults older than 18 years of age with a body mass index (BMI) less than 40 kg/m2 and an initial NPRS pain score of at least 4 on a scale of 1–10. Participants were required to be classified a minimum of grade 2 on the Kellgren–Lawrence scale. The allograft application was administered as an intra-articular knee application by anteromedial approach under ultrasound by a qualified health professional in a private medical setting. Patients were asked to fill out an initial questionnaire consisting of NPRS and WOMAC. Patients answered this same questionnaire at 30 days and 90 days after the initial allograft application.

Patient-reported outcomes were statistically analyzed for significance in improvement.

Results:

NPRS Scores

At baseline, patients reported an average pain score of 6.2 ± 0.4. At 30 days, the average NPRS was reported to be 4.3 ± 0.4. Within 30 days of the allograft administration, patient-reported pain levels reduced significantly. This was indicative of a negative relationship between patient-reported pain levels and time elapsed after the allograft application. By day 90, the average NPRS remained similar in value at 4.2 ± 0.4. The average change in NPRS between baseline and 90-day collection was 2.0 points (p < 0.00001). The 2.0-point NPRS improvement indicated that subjects were experiencing significantly less pain 90 days after the allograft application when compared to pain levels prior to the application.

WOMAC Total Sum

At the initial application, the average sum of the total WOMAC score was 53.5 ± 3.9. Thirty days after the initial application, the average sum was 41.4 ± 4.3. The 12-point decrease observed within 30 days of the allograft application suggested almost immediate significant improvements in pain, stiffness, and overall functionality. By day 90, the average sum of the total WOMAC score was 42.5 ± 4.9. The average change in the total WOMAC score between the initial application and the 90-day visit was 11 points (p < 0.05). The 11-point improvement between the initial allograft and 90-day examination suggested significant patient progression in improving all three WOMAC subsections.

 MCID Values

The MCID of NPRS was 0.78 which indicates a significant improvement in pain alleviation after allograft supplementation since the average difference in NPRS sums between the initial and 90-day visit was 2 points. The MCID of the pain subsection of WOMAC was determined to be 1.5. The difference between the initial and 90-day average sums was 2.3 points, therefore the improvement was clinically significant. The MCID of the stiffness subsection of WOMAC was 0.65, again significant when compared to the 1.1-point improvement between initial and 90-day patient visits. The MCID of the physical function subsect of WOMAC was 5.0, proving significant when compared to the 8.3-point improvement between initial and 90-day visits. The MCID of the total WOMAC scores was 6.9, which was exceeded by the 11-point difference between the initial allograft application and 90-day examination. The significant improvement in NPRS and all WOMAC subsections indicates that all patient improvements were clinically significant as well.

Conclusions: In conclusion, this observational study of umbilical cord tissue allografts demonstrated both statistically significant and clinically meaningful improvements in overall functionality and joint mobility when the allografts were used as a supplementation in patients with symptomatic degeneration of load-bearing articular cartilage in the knee joint. This study provides the potential for a more efficacious alternative in comparison to hyaluronic acid supplementation and other standard-of-care interventions. Additional randomized controlled trials are required to warrant potential allograft applications such as more accessible alternatives to invasive arthroscopy and knee replacement surgeries.


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