Poster Abstracts

The Durability and Efficiency of Cryopreserved Human Umbilical Cord Tissue Allograft for the Supplementation of Cartilage Defects Associated with the Sacroiliac Joint: A Case Series

POSTER ABSTRACT

Author(s)

AL

Albert Lai, MD

Medical Director
My Caring MD
Palm Dessert, California
NL

Naomi Lambert, BS

Clinical Site Coordinator
Regenative Labs
Pensacola, Florida

Abstract Title:

The Durability and Efficacy of Cryopreserved Human Umbilical Cord Tissue Allograft for the Supplementation of Cartilage Defects Associated with the Sacroiliac Joint: A Case Series

Background: The SI joint includes two cartilage facets, the sacral and iliac, which are susceptible to morphological changes with age, shearing forces, and repetitive trauma. (2) SI pain affects 15% of the US population, costing about 60 billion dollars annually in treatment. (3,4,5) Untreated SI joint cartilage defects result in pain, functional impairment, and reduced quality of life. Corticosteroid treatment may cause more long-term harm than benefit, along with a return to baseline pain within six months (7,13). SI fusion has an extremely high risk of complications, including 75% of patients experiencing adjacent segment degeneration within five years post-surgery. (15) Addressing symptomatic articular cartilage defects in patients with SI joint-related complaints remains a clinical challenge. Most clinicians agree that nonsurgical intervention is the standard of care, yet current literature has yet to prove a reasonable and durable procedural alternative to steroid injections.

Purpose/Objectives: Wharton’s Jelly (WJ) is a loose connective tissue found in the umbilical cord that functions as a structural scaffolding to protect the vessels of the cord from external forces containing collagen types I and III, hyaluronic acid, proteoglycans, growth facts, and many other elements [19]. WJ and load-bearing articular cartilage share homologous cartilage extracellular matrix components and qualitative and quantitative characteristics [20]. These analogous biomechanical qualities make WJ an ideal allograft to supplement structural tissue defects in the articular cartilage of patients with refractory sacroiliac joint pathology. Clinical applications of WJ as a tissue supplement are increasingly reported in the medical literature with positive functional quality of life and pain outcomes [21,22,23]. This IRB- approved retrospective observational protocol aims to report the safety and efficacy of birth tissue allografts applied in 38 patients with treatment-resistant sacroiliac (SI) joint pain through patient-reported pain scales.

Method:

Thirty-eight patients of age 18 or older who met predetermined inclusion and exclusion criteria were chosen for the study. Seventeen patients received WJ to the right SI joint, and 21 patients received WJ to the left SI joint.

All patients had radiographic evidence of SI joint cartilage degeneration and had failed prior systemic treatments. 2cc of WJ flowable allograft (100 mg WJ tissue) was applied to the SI joint's inferior third after negative aspiration for blood. All patients were monitored for 30 minutes post-procedure, no patients experienced adverse complications, and all were discharged in stable condition.

Patients were asked to complete a questionnaire on the day of the initial application and 90 days after. The questionnaire included NPRS, a numerical pain scale, and the WOMAC, measuring pain, stiffness, and function. The scores of the two scales were analyzed individually to allow for a more significant examination of the affected joint.

Results: Changes were recorded from baseline data obtained on the day of application to 90 days following the application. At baseline, the average NPRS score was 6.7 ± 2.1. At 90 days, the average NPRS score was 3.6 ± 2.3. Thirty-two out of the 38 patients (84%) reported lowered NPRS scores. At baseline, the average total WOMAC score was 56.1 ± 18.8. At 90 days, the average total WOMAC score was 43.3 ± 22.7. Twenty-nine (76%) reported lowered WOMAC scores at the 90-day mark.

Conclusions: The percent change analysis shows that while females reported higher initial and final NPRS and WOMAC scores, males showed a higher percentage of improvement. On average, females improved by 37% on the NPRS and 22.9% on the WOMAC. Males improved by 57% on the NPRS and 27.4% on the WOMAC. There were statistically significant improvements in pain, stiffness, and physical mobility between baseline and 90-day scores. The application of WJ was safe and efficacious in all 38 patients, with no adverse reactions reported.
To our knowledge, this is the first observational reporting of the safety and efficacy of WJ allograft applications to load-bearing articular cartilage degeneration of the SI joint. Limitations of this study include being unblinded with no additional imaging after application. However, using patient-reported NPRS and WOMAC scores helped eliminate an unblinded investigator's influence. Based on the increasing incidence of SI joint dysfunction, new literature cautioning the use of repetitive cortisone injections, and reports of SI fusion post-operative complications, alternatives to the current standard of care are warranted. Future randomized and prospective studies may further substantiate the efficacy and durability of WJ perinatal tissue allografts compared to cortisone injections, viscosupplementation, and, ultimately, SI joint fusion.

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