Pensacola, Fla.-based Regenative Labs published an observational study in Medical Research Archives documenting reduced pain and increased quality of life in patient-reported outcomes for 31 individuals who received cryopreserved human umbilical cord tissue allograft applications for defects affecting the paraspinal muscles and entheses of the cervical spine.
The study reported reductions in average Numeric Pain Rating Scale and Western Ontario and McMaster Universities Arthritis Index scores from the first to final visit across all application groups, according to a July 29 news release. The authors also reported statistically significant reductions in pain and WOMAC measures for both single- and double-application groups. A triple-application group reported the largest statistically significant reductions across all measured scales, from the initial visit to the final visit. Patients in the single- and triple-application groups reported improvement in quality-of-life scores. No adverse events or complications were reported during the study period.
| Measure | Single application | Double application | Triple application |
| NPRS (pain) | 5.20 to 4.13 | 6.00 to 3.11 | 7.00 to 1.86 |
| WOMAC Total | 39.73 to 22.80 | 35.44 to 33.67 | 51.57 to 43.29 |
The observational study included 31 patients with imaging-confirmed cervical paraspinal muscle degeneration and enthesopathy who received one to three ultrasound-guided applications of a cryopreserved umbilical cord tissue allograft at targeted sites spanning C1 to C7. Each application delivered 2 milliliters of allograft, and all patients had exhausted at least three months of conservative care before treatment.
The findings contribute to the growing body of published evidence evaluating birth tissue allografts for musculoskeletal conditions.
Regenative Labs said the publication adds to a library of 19 peer-reviewed papers the company has contributed to on the characterization and homologous use of birth tissue allografts. The company said it plans to continue investing in observational research and reporting patient-reported outcomes.
“Birth tissue allografts continue to draw interest in healthcare markets worldwide, and that interest has to be met with rigorous research and transparent reporting,” said Tyler Barrett, CEO of Regenative Labs and a co-author of the study.
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