Informed Consent for Structural Tissue Allograft Injection

The undersigned patient/guardian does hereby acknowledge and confirm that they have received a consultation regarding allograft injections containing stem cells and that consultation shall not serve in any capacity as a replacement for their primary care physician/provider. The consultation is to discuss, without guarantee, the possibility that the injection could provide some cushioning structural support and viscosity benefit to the patient. This product is intended for cosmetic topical use.

I understand that Joint Repair Clinic of MT is offering allografts containing stem cells, inclusive of additional procedures or modalities (pEMF table, ozone therapy, PRP therapy, microcurrent, etc.). These procedures are not to be construed as treatments or remedies to diagnose, treat, cure, or prevent any disease or injury, nor provide immunity against reoccurrence of such condition. No statements or implied treatments on this document have been evaluated or approved by the FDA.

Results Not Guaranteed: I understand that although positive results are desired, there cannot be any guarantee or warranty, expressed or implied, that I will be completely satisfied by the outcome or that I will not require additional treatments and/or ongoing treatment to achieve the result I seek. I understand and acknowledge that payment for the above procedure is non-refundable and should more treatment be desired, I will be responsible for purchasing other procedures to achieve the outcome I desire.

Alternatives: I understand there are alternatives to addressing joint problems: do nothing, physical therapy, surgical intervention, injection with steroids, manipulation or acupuncture for temporary relief, prescription and over-the-counter pain/anti- inflammatory medication.

The FDA recently re-confirmed, there is only one registered stem cell product, and while there is enormous promise in stem cell therapies, and thousands of ongoing experimental applications trying to establish efficacy, these are not at the point where they would meet the scientific standard.

The FDA has stated: Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm

"There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body." Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

The science of using HUCT allografts is still in the developmental stage, they are considered experimental and investigational. Professional judgment and expertise are needed in using allografts for cushioning and viscosity, and we urge anyone embarking on the use of HUCT allografts to consult the national health databases to evaluate current information from clinical trials and the FDA websites on human tissue should also be consulted to get its current evaluation of any therapy.

It is the consultant's goal to provide you with the information you need in order to decide whether to consent to the special procedure(s) being recommended to you.

Your signature on this document shall serve as verification that you have received that information and have given your consent to the procedure. You should therefore read this and any attached information carefully and ensure that all your concerns have been addressed by the consultant sufficiently before you give consent.

You understand if a chiropractor consulted with you regarding your neuromusculoskeletal condition, you are being referred to licensed medical professionals for allograft injections containing stem cells and the protocols will be up to their professional medical opinion.

Release of Liability: I release Joint Repair Clinic of MT and staff from liability associated with this procedure except for liability that may be imposed by the laws of the state of Montana.

Adverse reactions and possible side effects: It is possible for there to be unforeseen adverse reactions, side effects, and risks that are not included in this list. Some possible side effects can be: immediate pain at the injection site, stiffness is in the injected joint, bruising, allergic reaction (ex. to the sulfa in DMSO), infection, nerve or muscle injury, nausea/vomiting, dizziness or fainting, swelling after injections, bleeding, tendon rupture (if tendon inadvertently injected), depigmentation (whitening of skin). Thus, before undergoing one of these procedures, understanding the associated risk is essential. No procedure is risk-free. If any signs of a reaction happen, contact the medical provider immediately.

Referral for the following procedure has been recommended:

Structural Tissue Allograft Containing Human Umbilical Cord Tissue

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Upon your authorization and consent, this Joint Injection will be performed on you by a Montana Licensed Medical Provider. All invasive procedures carry the risk of unsuccessful results, complication, injury, or even death from both known and unforeseen causes, and no warranty or guarantee is made as to results or cure. You have the right to be informed of the nature of the procedure and its actual or potential risks, benefits, and side effects, as well as any reasonable alternative(s) and the side effects of such alternative(s). You also have the right to give or refuse consent to any proposed procedure or therapy at any time prior to its performance.

Stem cells arrive frozen, and once received they must be injected that day. By signing below, you are acknowledging that there is no refund if you do not keep your appointment.

Therefore, as stated above, your signature on this form indicates that:

1. You have read and understand the information provided in this form and any attachment to this form.
2. The procedure has been adequately explained as set forth above, along with risks, benefits, and other information described on this form.
3. You have had the chance to ask any and all questions regarding this procedure.
4. You have received all of the information you desire concerning the procedure.
5. You authorize and consent to the performance of the procedure with complete understanding of it and its risks and benefits.