Commercially Available Acellular Desiccant and Morselized Liquid Amnion Accelerate Bone Regeneration in Rams without Adverse Clinical Effects
[um_loggedin show_lock=yes]Authors: Ramon- Rivera-Barreno1, Moises Barcelo-Fimbres2, E. Bustamante-Montana1, Carlos A. Rodriquez-Alarcon1, Diana M. Beristain-Ruiz1, A. Hernandez-Perez1, Laurel Schnabel3, Andrew Krieger4, Bruce Werber5, Tony Rocconi6, Brandon T. Ames2, Eric Chow7
Affiliations: 1 Universidad Autonoma de Ciudad Juarez, Ciudad Juarez, Mexico; 2 Anicell Biotech, Chandler, Arizona; 3 North Carolina State University, Raleigh, North Carolina; 4 Animal Medical Group, Manhattan Beach, California; 5 Anu Life Sciences Davie, Florida; 6 MidSouth Equine Sports Medicine & Surgery, Tioga, Texas; 7 Animal Specialty & Emergency Center, Los Angeles, California
Introduction: Bone healing can be a source of major challenge for both the Veterinary Clinical and researcher working in the field of orthopedics. With the continued advancement in the field of regenerative medicine, these techniques continue to demonstrate their usefulness in the field of orthopedics. Several human and animal studies have demonstrated the ability of many of these materials to aid in normal bone healing. Amniotic material is one of the oldest regenerative therapies with reports of its usage dating back as early as 1910. In the past 10-15 years, the usage of amniotic materials in both the human and veterinary field has begun to growth with ample scientific evidence in a variety of conditions including bone healing.
Hypothesis/Objectives: The aim of this study was to evaluate the effectiveness of amnion in membrane and/or liquid form for bone regeneration for 120 days. It was hypothesized that the use of amniotic scaffold preserved as a membrane (BioScaff®) or a liquid morselized form (StemWrap+®), would accelerate bone regeneration compared to control (saline), and the combination of the products would have a synergistic effect.
Materials and Methods: Twelve healthy rams with an age greater than 8 months were divided into four groups. A 100mm in diameter circular defect was drilled in each tibial crest under general anesthesia. One leg in each ram was used as a saline treated control. The second tibial crest defect was treated as part of one of three test groups; equine preserved amniotic membrane (eAM), liquid morselized equine amnion (LAM), or eAM plus LAM. Following treatment, the patients were evaluated for rectal temperature, pain, lameness, inflammation, and blood work was performed on day 30 post treatment. Additionally, a radiographic analysis of the surgery sites was performed at days 0, 1, 30, 60, 90, and 120. Images were analyzed using Image J software. Data was analyzed using SAS software.
Results: No statistically significant difference was detected post treatment at any point during the study for rectal temperature between any groups. Additionally, no statistical differences were found between groups in lameness or pain scores at any time point during the study. The inflammation score and inflammation rate of the surgical wound at day 30 post treatment were both statistically decreased in all amnion treated limbs versus the control limbs. No abnormalities were detected in performed bloodwork on day 30 in any animal. Bone regeneration for all treated limbs was significantly increased in comparison to control limbs at all study time points.
Conclusions: The results of this study support the use of amnion to decrease inflammation and increase bone regeneration with no adverse clinical effects in animals. This study also demonstrated that the combination of the solid scaffold and the morselized liquid was not superior to the use of either product individually. The limitation to this study is that the observed effects in a ram may not the same in all other mammals. Additionally, surgically created bone defects do not accurately mimic the traumatic bone fractures encountered in a clinical setting.
Acknowledgements, Funding, and Conflicts of Interest: This study was funded by AniCell Biotech, the company that produces both the BioScaff® and the StemWrap+®.[/um_loggedin]