Study results show that cryopreserved amniotic membrane-umbilical cord (AM-UC) grafts are well tolerated and offer an alternative to pericardium patch grafts for safe and stable glaucoma shunt tube coverage.
Miami, FL – December 10, 2019 – Bio-Tissue, Inc., a TissueTech, Inc. company and leader in the clinical application of amniotic membrane and umbilical cord birth tissue products for unmet patient needs, announced today that the results from a clinical study on the use of amniotic membrane – umbilical cord grafts have been published in Ophthalmology Glaucoma, the peer-reviewed publication for the American Academy of Ophthalmology® in partnership with the American Glaucoma Society.
This study “Outcomes of the Shunt Tube Exposure Prevention Study: A Randomized Clinical Trial,” which was a multi-center randomized controlled trial supported by a National Institutes of Health (NIH) National Eye Institute (NEI) grant, was published in the Volume 2, Issue 6, November-December, 2019, pages 392-401, issue of Ophthalmology Glaucoma. The study was conducted by Hosam Sheha, MD, PhD,1,2,3 Celso Tello, MD, FACS,1,2 Lama A. Al-Aswad, MD, MPH,4 Mohamed S. Sayed, MD,5 and Richard K. Lee, MD, PhD.5
Study participants were comprised of adults with uncontrolled glaucoma undergoing glaucoma drainage device (GDD) implantation. Patients were randomized to receive GDD with either cryopreserved umbilical cord (AM-UC) or pericardium patch grafts to cover GDD tubes. Patients were followed-up clinically with anterior segment (AS) OCT to assess patch graft stability and host-tissue integration prospectively.
A total of 81 eyes of 81 patients (50 women, 31 men) with a mean age of 67±13 years underwent GGD implantation using Baerveldt (n = 72) or Ahmed valve (n = 9). Tubes were inserted in the anterior chamber (n = 71), sulcus (n = 6), or pars plana (n = 4). Tube ligation was performed with Baerveldt GDD along with fenestration (n = 51) or orphan trabeculectomy (n = 21). Tubes were covered with AM-UC (n = 41) or pericardium (n = 40). The mean follow-up time was 29±8 months (range, 13-40 months). Tube exposure occurred in one eye (two percent) in the AM-UC group at three months and in two eyes (five percent) in the pericardium group at two and six months (P = 0.54). Sequential AS OCT showed better host-tissue integration and significantly less graft thinning in the AM-UC group. Early graft thinning (≤ three months) occurred in five eyes (12 percent) in the AM-UC group and in 17 eyes (43 percent) in the pericardium group (P < 0.002). Late thinning occurred in two eyes (five percent) and 11 eyes (28 percent) in the AM-UC and pericardium groups, respectively (P < 0.007). Graft translucency and cosmetic appearance of the AM-UC graft were superior to those of the pericardium graft. No evidence of graft rejection or infection was associated with the patch grafts in either group.
According to Scheffer C.G. Tseng, MD, PhD, Chief Technology Officer and co-founder of Bio-Tissue, Inc., a TissueTech company, “We are grateful to receive the support from by the National Eye Institute, the National Institutes of Health for this multi-center randomized controlled trial. We are very pleased with the study results being published by this respected peer-reviewed publication supported by the American Academy of Ophthalmology and the American Glaucoma Society. We were extremely pleased to see the positive results demonstrate safety and efficacy of cryopreserved umbilical cord, known as AmnioGuard® commercialized by Bio-Tissue, Inc., as a tectonic graft to cover GDD.”
TissueTech and its wholly-owned subsidiaries Amniox and Bio-Tissue, are committed to addressing unmet patient needs. As such, the organization maintains a product portfolio of amniotic membrane and umbilical cord birth tissue products to help manage ocular surface disease, complex, chronic and surgical wounds, and musculoskeletal disease and injury.
About Bio-Tissue, Inc.
Bio-Tissue, Inc., a TissueTech, Inc. company, is the market leader in the clinical application of cryopreserved amniotic membrane-based products for the treatment of diseases and disorders of the ocular surface. Established in 1997, Bio-Tissue serves an unmet need for better surgical and therapeutic alternatives for helping eye care professionals manage ocular surface conditions, such as keratitis, recurrent corneal erosions, conjunctivochalasis, pterygium, and dry eye. Connect with Bio-Tissue on our Website, Facebook, LinkedIn and Twitter.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue, Inc., pioneered the development and clinical application of human placental tissue-based products. Founded in 1997, Bio-Tissue markets products for the ophthalmology and optometry markets; and Amniox markets products for use in the musculoskeletal and wound care markets. Clinicians have performed more than 500,000 human implants with the company’s products and published more than 360 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA to act as an anti-scarring, anti-inflammatory and anti-angiogenic agent and supporting epithelial adhesion and differentiation. Learn more at www.tissuetech.com.
1 Department of Ophthalmology, Manhattan Eye, Ear & Throat Hospital, New York, New York.
2 Hofstra Northwell Zucker School of Medicine, Hempstead, New York.
3 Herbert Wertheim College of Medicine, Florida International University, Miami, Florida.
4 Harkness Eye Institute, Columbia University, New York, New York, and
5 Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.