EIPH Study Application | AniCell Biotech

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*

Has the horse been on Lasix?

Has the horse been on Lasix in order to compete or as preventative? Has the horse bled through Lasix? Detail in history below:

History*

Please complete a full history. List any illness or injuries that might be relevant. When was the horse first diagnosed? Has he been on Lasix? Has he bled through Lasix? Any special circumstances the causes him to bleed?

Diagnosis*

Is the horse current on all of his/her vaccinations?*

File upload for additional information

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Max. file size: 64 MB.

Phase I EIPH Field Trial Client Consent Form*

I (Owner/Custodian) consent to the EIPH Amnion Study.

Title: Field efficacy of Amnion on improving EIPH 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 EIPH conditions in horses.

Study Design/Procedures:
Group A Thoroughbreds (IV Animotion protocol):
- Day 1: Receive ANIMOTION (IV admin) after cooling out on the day of workout, strong gallop with a final 1/8 blowout, or strong 2-minute lick.
- Day 2 : Normal Training Routine (NTR)
- Day 3 : NTR plus check labs (CBC, LFT, BMP – checking immune system, kidney and liver function, and electrolytes)
- Day 4 – 6 : NTR
- Day 7 : Workout 3 to 5 furlongs, followed by Pulmonary Bronchoscopy (scope)
- Day 8 – 20 : NTR
- Day 21: Decision to retreat with Animotion (IV Admin) after a workout, depending on the previous bronchoscopy, horse’s performance (training, behavior, etc.) and clinical presentation.
- Day 30 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.
- Day 60 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.
- Day 90 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.

Group B Thoroughbreds (Day of workout/race nebulizer protocol):
- Day 1 : Receive Anicell Nebulizer Solution (ANS) via Nebulizer admin AFTER cooling out on the day of workout, strong gallop with final 1/8 blowout, or strong 2-minute lick.
- Day 2 : Normal Training Routine (NTR)
- Day 3 : NTR plus check labs (CBC, LFT, BMP – checking immune system, kidney and liver function, and electrolytes)
- Day 4 – 6 : NTR
- Day 7 : Workout 3 to 5 furlongs, followed by Pulmonary Bronchoscopy (scope) AND ANS treatment #2.
- Day 8 – 13: NTR
- Day 14: Workout 3 to 5 furlongs, followed by Pulmonary Bronchoscopy (scope) AND ANS treatment #3.
- Day 15 and hereafter, if POSITIVE results, the horse would receive an ANS treatment AFTER every workout or race.
- Day 30 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.
- Day 60 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.
- Day 90 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.

Group C Thoroughbreds (Prophylaxis or Preventative protocol) :
- Day 1 : Treat with ANS via Nebulizer admin after NTR (day 1 in this protocol will be 3 days before a planned workout or race).
- Day 2 : NTR
- Day 3 : NTR plus check labs (CBC, LFT, BMP – checking immune system, kidney and liver function, and electrolytes)
- Day 4 : Planned 3 to 5 furlong workout (handily) followed by Pulmonary Bronchoscopy.
- Day 5 – 7 : NTR
- Day 8 : NTR plus ANS treatment #2
- Day 9 : NTR plus repeat labs CBC, LFT, BMP – checking immune system, kidney and liver function, and electrolytes)
- Day 11 : Planned 3 to 5 furlong workout (handily) followed by Pulmonary Bronchoscopy.
- Day 12 – 14 NTR.
- Day 15 : NTR plus ANS treatment #3
- Day 16 - 17 : NTR
- Day 18: Planned 3 to 5 furlong workout (handily) followed by Pulmonary Bronchoscopy.
- Day 19 and hereafter, if POSITIVE results, the horse would receive an ANS treatment 3 days before every workout and/or race.
- Day 30 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.
- Day 60 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.
- Day 90 : Questionaire – follow up with trainer as to horse’s performance and health. Repeat Bronchoscopy and labs if needed.

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 ($1450). 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.

AniCell EIPH Field Study Application

AniCell EIPH Field Study Application

AniCell EIPH Field Study Application