Ophthalmology Study Subject Application

Welcome to AniCell’s Online Trial Data Retrieval System.

The complete protocol is listed below.Â If you have any questions, please do not hesitate to reach out to our hotline at 480-477-0150.

IMPORTANT: Please have all results compiled prior to beginning to fill out the Results Page.

You will not be able to return to this form once submitted.

Veterinarian*
Prefix First Last Suffix
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Contact Type*
Email
Cell Phone
Owner Name*
Owner Phone
Owner Email
Patient Name*
Patient Breed*
Patient Age*
Patient weight (in lbs.)
Patient Sex*
Study Indication Type*
Please choose the study protocol to be followed.
History*
Please complete the full history. List any illness or injuries that might be relevant. Be sure to include all previous diagnosis, prior diagnostics, any medications, prior treatments, causation, keratomalacia, associated lesions, associated ocular disease, previous URI (if known or applicable) and duration of the injury. If it is an ulcer, please state the cause.
Where is the involvement located?*
Cornea Size (Length in mm)
Please measure the length of the defect in millimeters. Record size in number format only, I.E. 2.5 for 2.5mm
Cornea Size (Width in mm)
Please measure the length of the defect in millimeters. Record size in number format only, I.E. 2.5 for 2.5mm
Date of Diagnosis*
MM slash DD slash YYYY
Diagnosis*
Please upload an image of the involvement.
Drop files here or

Max. file size: 64 MB.
If possible, please include a clinical image.
Ophthalmology Study Application*
I (Patient Owner/Custodian) consent to the Ophthalmology Protocol.
Title: Ophthalmology Study

Principal Investigator: Dr. Robert Peiffer, DVM, PhD, DACVO, rlpeiffer@hotmail.com

AniCell Biotech’s mission is safely preserving ACTIVE life through the development of safe and quality products that promote tissue regeneration. Based on your expertise in the role of reproductive medicine, you are invited to participate in this mission by enrolling your animal in a clinical research study. Your participation is entirely voluntary, and you may withdraw your animal from the study at any time by notifying the Principal Investigator. There is no penalty if you choose not to participate.

Study Purpose:
To understand the effectiveness of using an unadulterated equine amnion-derived product (UEADP) to improve eye health in animals.

Study Design/Procedures:
AniCell will supply amnion products for use on animals with a variety of eye pathologies. Four questionnaires will be required at the following intervals:
(1) prior to treatment
(2) seven days post
(3) fourteen days post
(4) twenty-eight days post
(5) forty-two days post

Risks and Benefits:
Suffice it to say, there are risks with any product usage. Fortunately, to date, there has not been a single severe adverse event ever documented in any of the literature over the past 110 years of recorded usage. As for our AniCell amnion ocular applications with our AniOcular Product Line, there has only been mild irritation in under 1 % of the cases based on over four hundred applications performed in the last four years.

Study Costs and Compensation:
The amnion product to be used has been discounted to zero for this study. The veterinarian’s administration of the product and lab work to be performed will be done at normal costs.

Confidentiality:
The data collected in the course of this study is confidential. In any publication or presentation of the study data, we will not include information that would make it possible to identify a research participant. Research records will be kept in a locked file; only researchers will have access to the records.

Statement of Owner Consent:
In giving my consent by signing this form, I acknowledge that I have been informed of the purpose, nature and risks of this study and its associated procedures, as well as any possible side effects.

I have read and understood the above information. I have been given the opportunity to ask questions and receive answers, and I consent to participate in the study. I further certify that I am the owner (or duly authorized agent of the owner) of the pet listed above.

Please don’t hesitate to contact us if you have any questions or concerns about this study.
If you have any questions or concerns regarding the study and would like to talk to someone other than the researchers, please contact:

Brandon Ames, CEO
145 S. 79th St.
Chandler, AZ 85226
Mobile: 602-918-2637 ● 888-918-2637
www.anicellbiotech.com
brandon@anicellbiotech.com

You will be given a copy of this form to keep for your records.

AniCell Biotech, LLC Research Study

Summer 2020

Principal Investigators

Robert Peiffer
Heather Brookshire
Jens FritscheÂ
Thomas DulaurentÂ
Susan CarastroÂ
Elizabeth Lutz

Study Information

Study Duration: August 1-December 31, 2020
Case Numbers: estimate 4-5 cases per PI
Publication: Submission to Veterinary Ophthalmology or another online quick access journal
Study Links:

Ophthalmology Application

https://anicellbiotech.com/ophtho-followup

Title

Examination of Accelerated Healing Properties of Amnion Membrane Transplantation for Ocular Surface Disease in Canine and Feline Patients â€“ Observational Case Series Study

Hypothesis

Dogs and cats with ocular surface disease treated with amnion post keratectomy or trauma will heal faster than the average of surgical candidates managed traditionally without applied amnion.

Mechanism involves release of soluble chemokines by the membrane which hydrolyzes over several days. It does not provide structural support nor a scaffold for fibrosis and its application may require combined use of an autologous tissue or biosynthetic graft, a third eyelid flap, or a temporary tarsorraphy. These ancillary procedures should be described in the protocol

Aim of the study:

Evaluate the use of dehydrated amniotic membrane (Anicell) in the management of ocular surface disease in dogs and cats

Study design:

Multicenter prospective study
Inclusion examples: Includes Epibulbar Melanoma (EM) in dogs, Symblepharon in cats, Ulcerative Keratitis, Feline Corneal Sequestrum (FCS), Limbal Dermoids, conjunctival defects, tumor excision, lid reconstruction, and any other ocular surface-related diseases where amnion application may be warranted.Â
Exclusion criteria: The mechanism of action for amnion is inflammation.Â Use of any drug that suppresses inflammation would be contra-indicated. Animals with conditions that must be administered and cannot be weened off of NSAIDS or corticosteroids would be excluded from the study.Â Animals with conditions such as chronic pervasive skin allergies, osteoarthritis, or other inflammatory conditions should consult Dr. Peiffer or Brandon Ames prior to admittance to the study.Â A dog with Hyperadrenocorticism or high levels of inflammation may not be the best subject for this study.Â Please use clinical judgement when selecting cases, keeping in mind that NSAIDS and cortiosteroids are contraindicated with amnion application.

Materials:

Patients presented with various types of ocular surface disease, including those requiring surgical intervention.
Product TypeÂ : single layer dehydrated amnion membrane (CanisCell AniOcular)

Methods:

Surgery
- Analgesia, anesthesia, preparation at surgeonâ€™s discretion, but detailed
- For cases of EM: if indicated Incisional or excisional biopsy with with a 1 mm margin around the lesion, noting depth.
- Single layer of amniotic membrane applied and held in place with third eyelid flap.
- Additional procedures (i.e. tarsorraphy, Hotz Celsius for the treatment of associated entropion) to be described

Post-Operative Medical Treatment
- At discretion of surgeon but detailed. Note: Topical and/or systemic corticosteroids AND NSAIDS are contraindicated with amniotic membranes
- AntibioticsÂ either topical and/or systemic at discretion of surgeon

Examination Timepoints & Data Collection

Baseline (D0), 7, 14, 28, & 42 days

Data Collection Metrics

Date of examination/procedure
Signalment
- breed, gender (intact/neutered) age, affected eye.
History
- Duration of lesion
- Diagnoses
- Prior diagnostics, (i.e. histopathology)
- Prior medical (topical and/or systemic) management and duration or surgical management
- Pathogenesis of lesion (if known)
- Infected/non-infected based on the presence or absence of infiltrate or cytology
- Presence or absence of keratomalacia
- Associated historical or contemporary ocular /adnexal disease
- Other pertinent medical history/information
Clinical Measurements/Descriptions
- Record location of lesion
- lesion extent- measurements (length & width in mm; depth (superficial, deep, perforating) at each evaluation
  - Extent of surface involved â€“ (baseline measurement) and % improvement/healing at each evaluation time will be calculated. Corneal healing time in days will also be determined from this data.
- Grade vascularization level (mild, moderate, severe) & depth (superficial, partial thickness, deep)
- Grade associated uveitis if present (mild, moderate, severe)
- Evaluation of transparency of healed corneal tissue (opaque, translucent, transparent)
Images at each evaluation
Additional procedures
Alterations in medical regimen over time – detail
Adverse events/complications
- spread of underlying infection to adjacent cornea or anterior chamber
- failure of amnion to be retained
- post-op infections
- post-op calcifications
- dissolution or displacement requiring replacement of amnion required
- progression of corneal disease despite application of amnion
- Disasters should be accompanied by tissue submission if possible
Diagnostic Options
- Cytological Evaluation (with cytobrush to characterize inflammation) on days 7, 14, and 28
- On day 42Â : Snip/shave biopsy/histopathology of healed tissue (submitted flattened on a cellulose sponge and immersed in 10% formalin) to evaluate quality and extent of conjunctival/corneal regeneration
- Ultrasound Biomicroscopy (UBM) â€“ high-resolution imaging of corneal structure
- Optical Coherence Tomography (OCT) â€“ high-resolution cross-sectional images of cornea
- Bacterial culture and sensitivity
- PCR (for FHV 1 if applicable)