AniCell Sesamoiditis Field Study Application

AniCellÂ SesamoiditisÂ Field Study Application

AniCellÂ SesamoiditisÂ Field Study Application

Please complete the Sesamoiditis Field Study Application. We will evaluate the application and give you a call to coordinate the treatment process to be performed.

Study inclusion requires radiographic detection of abnormal proximal sesamoid bone vascular canals > 2mm wide with nonparallel borders.Â

Veterinarian*
Prefix First Last Suffix
Contact Type*
Email*
Cell Phone*
Address*
Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country
Horse Custodian Name (Owner, Lessee, Farm Manager, Other)*
Horse Name or Barn Name*
Sex*
Height*
Breed*
Age*
Approximate Weight*
Date of Diagnosis*
MM slash DD slash YYYY
History*
Please complete a full history. List any illness or injuries that might be relevant. When was the horse first diagnosed? Age or Duration of lesion, inciting cause, severity (grade) of the lesion, previous diagnostics and treatments, etc.
Diagnosis*
Is the horse current on all of his/her vaccinations?*
File upload for additional information
Drop files here or

Max. file size: 64 MB.
Phase I Sesamoiditis Field Trial Client Consent Form*
I (Owner/Custodian) consent to the Sesamoiditis Amnion Study.
Title: Field efficacy of Amnion on improving sesamoiditis conditions in horses.

Principal Investigator: Dr. Chris Bradley, PhD, cbradley@anicellbiotech.com, 480-477-0105

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 sesamoiditis conditions in horses.

Study Design/Procedures:
GROUP A THOROUGHBREDS (Graded diagnosis is severe disease, with or without ligament involvement):
- Day 1 : Treat affected sesamoid with AnimatrX (1 ml of product) via subcutaneous injection over the affected sesamoid. If treating more than 1 sesamoid in that fetlock, may divide dose to ½ ml per sesamoid. If treating another sesamoid in a contra-lateral fetlock, then use 1 ml per each sesamoid. NEXT, immediately apply Shock Wave therapy (to illicit inflammatory response) to the sesamoid.
- Day 2 – 14 : Normal Farm Routine (NFR). This is to include previous diet, supplements, and daily exercise via turnout in a large pasture. NO stall rest.
- Day 15 : Treat affected sesamoid with Shock Wave treatment #2, to re-stimulate the neo-vascularization and regenerative process.
- Day 16– 28 : NFR
- Day 29 : +/- Shock Wave treatment #3.
- Day 30 – 41: NFR
- Day 42 : Repeat x-rays, +/- ultrasound exam and re-grade the sesamoid disease. If positive response, pending level of severity of sesamoiditis, decide to apply treatment #2 using AnimatrX or AnimatrX-D.

GROUP B THOROUGHBREDS (Graded diagnosis is mild-to-moderate sesamoiditis, with or without ligament involvement):
- Day 1 : Treat affected sesamoid with AnimatrX -D (1 ml of product) via subcutaneous injection over the affected sesamoid. If treating more than 1 sesamoid in that fetlock, may divide dose to ½ ml per sesamoid. If treating another sesamoid in a contra-lateral fetlock, then use 1 ml per each sesamoid. NEXT, immediately apply Shock Wave therapy (to illicit inflammatory response) to the sesamoid.
- Day 2 – 14 : Normal Farm Routine (NFR). This is to include previous diet, supplements, and daily exercise via turnout in a large pasture. NO stall rest.
- Day 15 : Treat affected sesamoid with Shock Wave treatment #2, to re-stimulate the neo-vascularization and regenerative process.
- Day 16– 28 : NFR
- Day 29 : +/- Shock Wave treatment #3.
- Day 30 – 41: NFR
- Day 42 : Repeat x-rays, +/- ultrasound exam and re-grade the sesamoid disease. If positive response, pending level of severity of sesamoiditis, decide to apply treatment #2 using AnimatrX or AnimatrX-D.

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 108 years of recorded usage. As for our AniCell intravenous or nebulized application of the products, there has not been a single safety event in the over one hundred applications performed in the last two years.

Study Costs and Compensation:
The amnion product to be used has been discounted to half-price ($225). 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 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 horse 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.