Novel amniotic membrane product supports fetal-like healing
A cryopreserved amniotic membrane in a self-retaining ring (ProKera, Bio-Tissue) is a convenient, easy-to-use product that promotes tissue repair via a regenerative, scarless process.
By Cheryl Guttman Krader; Reviewed by Neel R. Desai, MD
Cryopreserved amniotic membrane in an FDA-approved medical device (ProKera, Bio-Tissue) affords surgeons a powerful and convenient modality for accelerating ocular surface healing in a regenerative process that provides better anatomic and functional outcomes, according to Neel R. Desai, MD
The cryopreserved amniotic membrane acts as a scaffold for supporting new tissue growth, which is also a feature of dehydrated amniotic membrane. However, the cryopreserved product uniquely retains the tissue’s extracellular matrix components that modulate adult healing and aid in tissue regeneration. Laboratory studies analyzing the cryopreserved amniotic membrane confirm the integrity of heavy-chain hyaluronic acid, proteoglycans, and other connective tissue constituents (collagens, laminin, and fibrin) together with a variety of cytokines and growth factors that together provide anti-inflammatory, anti-angiogenic, and anti-fibrotic activity.
Therefore, while dehydrated amniotic membrane serves as a passive dressing, the cryopreserved product is an active biologic agent that promotes a scarless fetal healing process, resulting in regeneration of normal clear tissue rather than disorganized scar, explained Dr. Desai, director, Cornea and Refractive Surgery, The Eye Institute of West Florida, Largo, Clearwater, and St. Petersburg.
“The development of scar tissue as a consequence of inflammation and healing has been an ongoing challenge in ocular surface reconstruction and disease management,” he said. “In the past, we’ve had to weigh the advantages of using a steroid to inhibit inflammation and scarring against its drawback of impeding the healing process.
“With the cryopreserved amniotic membrane, ophthalmologists have a unique, convenient new option to re-create the desirable fetal healing process without having to accept any tradeoffs,” Dr. Desai said. “It has allowed me to achieve better outcomes in cases that would have otherwise healed with vision-limiting scarring, and as an in-office procedure, it has allowed me to avoid many trips to the operating room along with the associated cost and delay.”
Dr. Desai said he has used cryopreserved amniotic membrane with good results in a variety of situations, including in eyes with ulcers of infectious, neurotrophic, or autoimmune origin, to prevent rejection after high-risk corneal transplants, and to encourage re-epithelialization after phototherapeutic keratectomy or corneal crosslinking.
Although the cryopreserved amniotic membrane was originally marketed as loose sheets that needed to be sutured or glued over the lesion in the operating room, it is now available in a point-of-care device in which the membrane is held in a 16-mm self-retaining ring. Under topical anesthesia, the latter platform is placed onto the anesthetized eye much like a bandage contact lens.
“The procedure takes no more than 20 seconds and it can be done in the office, eliminating any waiting time before initiating treatment, unlike when patients must be taken to the operating room,” Dr. Desai said. “The opportunity to intervene immediately after diagnosis with a product that inhibits the inflammatory, angiogenic, and fibrotic pathways is an important advantage that helps to enhance outcomes further.”
Dr. Desai pointed out that CMS has a specific code for the cryopreserved amniotic membrane (65778) that allows for reimbursement of the in-office procedure and only a 10-day global period.
Neel R. Desai, MD
Dr. Desai is a consultant to Bio-Tissue.