Evidence of Site-Appropriate Tissue Remodeling
ACell’s Urinary Bladder Matrix (UBM) has a breadth of research supporting its unique characteristics, as well as its value in clinical settings. The extensive body of research includes more than 100 preclinical and 50 clinical peer-reviewed articles. Summaries of key scientific articles are provided below.
Site-Appropriate Tissue Remodeling with UBM Technology
Macrophage phenotype as a predictor of constructive remodeling following the implantation of biologically derived surgical mesh materials.
Brown BN, Londono R, Tottey S, Zhang L, Kukla KA, Wolf MT, Daly KA, Reing JE, Badylak SF¶. Acta Biomater. 2012 Mar; 8(3):978-87.
This preclinical study described the tissue remodeling response to 14 different commercially available biologic surgical mesh devices in a rat model of abdominal wall repair. Remodeling of the ECMs was measured using a histologic assessment at 14 and 35 days after surgery, and the histologic scoring was then correlated to the macrophage phenotype. The histologic and macrophage phenotype outcomes were then evaluated for statistical correlation. Of the 14 ECMs tested, the MatriStem UBM technology had the most favorable host remodeling response at both 14 and 35 days. Implant devices associated with a site-appropriate tissue remodeling response were correlated with an early, elevated presence of the M2 macrophage phenotype.
Complex Hernia Repair with Gentrix
Long-term clinical, radiological, and histological follow-up after complex ventral incisional hernia repair using urinary bladder matrix graft reinforcement: a retrospective cohort study.
Sasse KC†, Lambin JH, Gevorkian J, Elliott C, Afshar R, Gardner A, Mehta A, Lambin R, Peraza L. Hernia. 2018; doi: 10.1007/s10029-018-1830-0.
This retrospective clinical study assessed the long-term outcomes of complex ventral incisional hernia repair using UBM graft reinforcement in 64 patients at a single center, over a five year period. All patients were classified as either moderate or severe cases. Post-operative follow-up ranged from 12-70 months, with a median follow-up time of 36 months. A 24-month statistical analysis displayed a 4% recurrence rate, while the overall recurrence rate was 15.6%. Radiographic and histological imaging displayed long-term hernia repair with host tissue remodeling comparable to native fascia. Study results provide clinical evidence of safety and efficacy when utilizing UBM for reinforcement following a complex ventral hernia repair.
|Median Follow-up Time (months)||36 (12-70)|
|Total Recurrences||10 (15.6%)|
|Median Time to Hernia Recurrences (months)||32 (4-5)|
|Surgery for Repair of Hernia Recurrence||9 (14%)|
|Major Wound Care||13 (20%)|
|Median CCS Score (out of 115 possible)||16 (1-106)|
Complex Wound Management with Cytal and MicroMatrix
Complex wounds treated with MatriStem xenograft material: case series and cost analysis.
Sasse KC†, Ackerman EM, Brandt JR. OA Surgery. 2013 Dec 01;1(1):3.
This clinical, retrospective case series reviewed 10 cases of complex open wounds managed with MicroMatrix and/or Cytal Wound Matrix 1-Layer devices. Treatment costs with the UBM devices were compared to alternative wound treatment modalities at the same institution, including Negative Pressure Wound Therapy (NPWT). The cases were complex wounds ranging from recurrent, non-healing wounds to wounds in patients with compound comorbidities. Utilizing weekly applications of the UBM devices, authors achieved wound closure in all 10 cases without infection or complication by a median of 11 weeks. The authors concluded that ACell’s wound management devices allowed for healing of complex wounds at lower costs due to requiring less material and employee hours than NPWT with comparable healing times.