FDA’s Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
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Comparison Review: Lyophilized Membrane with Cryopreserved Amniotic Membrane
Author: Russell Health, Inc.
The body’s primary response to injury is to repair itself and maintain homeostasis for survival. This process is also known as tissue recovery, involves inflammation, cell proliferation and tissue regeneration. The human amniotic membrane is being widely used by providers to supplement and repair damaged tissue to enhance and restore tissue function. Thus, amniotic membrane is also being used by eye care providers to serve as a natural barrier and to support re-epithelialization through its growth factor-rich matrix.
Cyropreserved amniotic membrane (CAM) and lyophilized amniotic membranes are being used by optometrists and ophthalmologists to facilitate healing with epithelial defects, LSCD, dry eye disease, degeneration, infection and inflammation disorders.
Results
A Comparison of Lyophilized Amniotic Membrane with Cryopreserved Amniotic Membrane for the Reconstruction of Rabbit Corneal Epithelium, is a clinical comparison of the effect of cryopreserved amniotic membrane (CAM) with lyophilized amniotic membrane (LAM) on the reconstruction of rabbit corneal epithelium. According to the study, keratinization of the reconstructed corneal epithelium occurred on the LAM and CAM at the air liquid culture after 6 days. The basal layer of normal limbal epithelium has many excellent proliferating cells; the corneal epithelium reconstructed on the LAM and CAM also had excellent proliferating cells, with more in the 6 day cultures. The results show that the LAM can also serves as a stem cell niche, in a similar or slightly better manner than the CAM.
The study states: “A lyophilized amniotic membrane (LAM) has a higher rate of graft take, a longer shelf life, is easier to store, and safer, due to gamma irradiation, than a cryopreserved amniotic membrane (CAM).”
Conclusion
The use of LAM is recommended due to its many advantages. The study states: “A lyophilized amniotic membrane (LAM) has a higher rate of graft take, a longer shelf life, is easier to store, and safer, due to gamma irradiation, than a cryopreserved amniotic membrane (CAM).”
The reconstructed corneal epithelium model in this experimental study is expected to be a good in vitro model for transplantation in patients with a damaged cornea.
Human Tissue Therapy
Acellular minimally manipulated tissue allografts are utilized to help treat a wide variety of conditions and are shown to help the body boost its ability to heal itself. The allografts help promote the body’s own healing process to assist in the reconstruction and regeneration of injured tissue. This can lead to an alleviation of pain, and a quick recovery.