Regenerative Medicine Consent Form

Informed Consent for Regenerative Medicine Joint Injection Procedure

Purpose: The purpose of this document is to provide written information regarding the risks, benefits, and alternatives to the elective procedure of injection with human amniotic membrane and structural Wharton's jelly (herein referred to as regenerative cellular therapy). This is supplementary to the discussion you have had with the clinician. It is important you fully understand this information – so please read this document carefully. This procedure is NOT FDA approved by the U.S. Food and Drug Administration (FDA) and makes no claim to cure or treat any specific condition or disease.

I have been advised and consulted regarding the use of regenerative cellular therapy. It has been used for a number of years in orthopedics and sports and physical medicine to treat muscle and ligament injuries, pain problems, and skin lesions. The cells used are sterile, human tissue allograft derived from healthy, c-section deliveries and are intended for homologous use.

Protocols: WJ-PURE+ and VITTI-PURE are minimally manipulated, DMSO free, bio-ethical umbilical cord products from donated human tissue manufactured under the AATB and FDA HCT/P 361 guidelines for homologous use in clinical settings. Their proprietary process is absent of harmful enzymes and chemicals to preserve structural integrity. 20% of every lot manufactured is sent for sterility and endotoxin testing by a 3rd party CLIA Certified laboratory. In addition, Vitti Labs utilizes Tunable Resistive Pulse Sensing (TRPS) for each lot and a biannual Characterization Report produced by external laboratories for transparency and validation. Vitti LabsTM products meet the criteria under 1271.3(d) as an HCT/P, and therefore are regulated under 21 CFR 1271 and Section 361 of the PHS Act. These products are not approved by the FDA. Vitti LabsTM products are only intended to be used by Medical Professionals. This product may contain live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function. This product contains tissue components such as hyaluronan, elastin, collagen fibers, growth factors, cytokines, and nanoparticles which stimulate homologous benefits; therefore, it is not reliant on the presence nor on the metabolism of the cells in this product to create a therapeutic benefit. This product does meet the criteria under 1271.3(d) as an HCT/P, and therefore is regulated under 21 CFR 1271 and Section 361 of the PHS Act.
Donor Screening: The source has been determined to be eligible for human use by a licensed physician, on behalf of the tissue bank. Review of donor records includes donor medical history and risk behavior assessment, medical records, and recent physical examination, which indicate to the tissue bank that the donor is free from risk factors for, and clinical evidence of, infection due to relevant communicable diseases and other exclusionary disease conditions. All lab testing is registered by the Food and Drug Administration (FDA) and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and 42 CFR part 493. Cellular products derived from donated human tissue are deemed qualified for transplantation by a tissue bank if it meets the following criteria: 1) the results from the donor pre-screening lab tests specify the donor to be free from risk factors and active infections of applicable communicable disease agents and diseases as required by the FDA, and 2) donor results from the pre-screening lab tests must be negative and/or non-reactive for the following applicable communicable disease agents determined by the following: testing for Hepatitis B and C Viruses (HCV/HBV); testing for Human Immuno-Deficiency Viruses Types I and II (HIV I/II AB); Nucleic Acid Testing (NAT) for HIV, and Hepatitis B and C; Core Antibody Testing for Hepatitis B (HBC AB); Testing for Hepatitis B Surface Antigen (HBS AG); Human T-Cell Lymphotropic Viruses I and II (HTLV I/II); and testing for Reactive Plasma Reagin (RPR) (which tests for non-specific antibodies which may indicate a syphilis infection). The tissue bank that provides the injectables to our office for this procedure has informed this office that the injectable and donor have met the above requirements. By law, the laboratories performing human specimen tests are certified and meet the requirements as determined by the Centers for Medicare and Medicaid (CMS), per CLIA and 42 CFR part 493, and the FDA requires patient records to be properly maintained by storing the allograft ID number (lot number) for purposes of tracking the allograft post treatment.
Indications & Procedure: I have been informed indications for this injection may include but are not limited to: Inflammation, inflammatory conditions, degeneration and deterioration diseases, arthritic diseases, soft tissue injury and inflammation, and pain associated with the foregoing. I understand after my skin has been thoroughly cleaned, the area being treated will be entered with a needle attached to a syringe.
Anticipated Outcomes & Benefits: From this procedure, anticipated outcomes and benefits may include relief from pain or pain reduction, increased circulation, increased exercise tolerance, improved pain threshold, increased range of motion, improved joint

function, or other structural improvements. I understand that treatments are not guaranteed and are not intended to cure or otherwise treat any disease process.

Adverse Reactions: If any signs of infection or reaction occur, contact your clinician immediately. Adverse reactions or outcomes that potentially involve the use of this tissue product must be reported.

Contraindications: WJ-PURE+ and/or VITTI-PURE are contraindicated in patients with a known hypersensitivity to WJ-PURE+ and/or VITTI-PURE. It should not be injected into the spinal canal or vital organs, including the areas of the central nervous system. These products are not intended for use as a bone graft or bone substitute. These products should not be injected into areas of active infection, or in patients who likely have active infections or conditions that may cause a substantial risk to the patient.

Risks: Before undergoing any procedure, understanding the potential risks is essential, as no procedure is risk free. The following risks are recognized, but there may also be risks not itemized here that are not foreseen by clinicians. By my initials on this paragraph, I attest that the most likely material risks and complications from regenerative cellular therapy have been discussed with me. Adverse reactions may include, but are not limited to:

allergic or adverse reactions to bandages, tape, gauze, or agents used to clean the skin; itching at the injection site; numbness; soft tissue swelling, bruising, or hematoma formation; vasovagal reaction (i.e., fainting or dizziness) or nausea or vomiting; temporary increased muscle spasm; trauma to nerves including temporary or permanent nerve paralysis; temporary injection and post-injection discomfort or pain; infection (though rate of occurrence is extremely rare); transmission of communicable, infectious or genetic diseases including bacterial, fungal or viral transmission; worsening of existing infections if injection is unknowingly performed on patient with existing and undisclosed joint or systemic infection; breakage of equipment including vial/needle; recurrence of symptoms or unsatisfactory result; damage to associated structures; injury to adjacent tissues or nerve injury; tendon scarring resulting in pain on motion; potential rupture of tendon if it is in path of injection and inadvertently injected; minor bleeding post-injection; fluid accumulations, minor edema, or swelling post-injection; weak grip (in wrist/elbow injections); spinal cord injury (with back injections); slow recovery; stiffness; tingling or unpleasant feeling in the area that was injected. I also understand that there might be potential/theoretical risks (ie risks observed in animal studies) such as tumor formation and unwanted immune responses.

While great measures to ensure the safety of the product(s) have been taken by the supplier(s), I understand that current technologies cannot preclude the transmission of certain diseases known or unknown, and that neither the supplier of the injectable nor the clinician performing this procedure can make any claims concerning the biologic properties and safety of this therapy despite the tissue bank confirming it has collected, processed, screened, tested, stored, and distributed the product in compliance with all current FDA regulations concerning HCT/Ps.

Alternatives: I have been advised of alternatives to regenerative cellular therapy, including: 1) Doing nothing, which may lead to further deterioration and degeneration, restricted mobility and pain. 2) Taking oral pain killers or anti-inflammatory agents which carry other risks such as addiction, injuries to organs like the liver, kidneys and stomach, cause GI bleeds, increase the risk of heart attack or even death. 3) Joint replacement surgery (if applicable) which carries risks similar to allograft injection therapy as well as blood clot, leg length discrepancy, joint dislocation, fracture, heart attack, infection including staphylococcus infections and MRSA, implant failure or prosthetic loosening, neurovascular damage, re-operation, stroke and death. Alternative treatments, prescriptions and therapies – and their benefits, material risks and disadvantages – have been explained to me in terms I understand, along with probable consequences of declining recommended or alternative therapies.

I understand and accept that the procedure to which I am consenting is regenerative cellular therapy and the details of this treatment including anticipated benefits, material risks and disadvantages have been explained to me in terms I understand.

By signing this form, I am indicating that I have not been advised that I have an intra-articular infection in the joint or systemic infection in the areas to be injected, that I have not been informed that I am HIV positive or otherwise immuno-compromised, and that I am not pregnant or lactating. I am not a donor organ recipient, I am not currently taking immunosuppressive medications, I am not currently receiving chemotherapy or radiation and I do not currently have a diagnosis of cancer nor have I been previously diagnosed with cancer.

I have informed the clinician of my known allergies, as well as all medications I am currently taking, including prescriptions, over-the-counter remedies, herbal therapies and supplements, aspirin, and other recreational drug or alcohol use, and I have further been advised as to whether I should take any or all of these medications prior to the injection, the day of the injection, or in the days after the injection.

I understand that regenerative cellular therapy is considered by insurance companies and others to be experimental, and thus it is not covered by insurance, and that no one can be fully aware of all possible side effects and complications of this protocol. 

I understand and accept complications are possible related to any injectable, medical, or surgical procedure or therapy.

I am aware that no guarantees about the results of this therapy have been made. I understand that these treatments are not warranted to cure any medical conditions nor provide immunity against re-occurrence of such conditions.

I have been advised of what to expect post-injection, including but not limited to estimated recovery time, anticipated activity level, and possibility of additional therapies. I have also been informed that if I am to receive a local anesthesia and/or other pain management agents, or have an extremity joint injected which I am required to use for operation of a motor vehicle, that I will not operate a motor vehicle or dangerous machinery after same, and I will be accompanied to and from the office by a responsible adult, as necessary for the procedure, unless the local anesthesia or joint injection is unrelated to cognitive and motor functions and does not impact my ability to operate such vehicles or machinery.

The clinician has answered all of my questions regarding this therapy and I understand the procedure to my complete satisfaction. I have no unanswered questions and I know the above listed clinician to perform, and/or assist as necessary, the above stated injection. I further authorize the clinician to perform any other procedure that in their judgment may be necessary or advisable should unforeseen circumstances arise during the procedure.

My consent and authorization for this elective procedure is strictly voluntary. I have been informed of the possibility of complications as detailed above, from both known and unknown causes, and freely assume those risks. I understand that if I am not willing to accept all risks associated with this procedure, I should not have this therapy. I agree to adhere to all safety precautions and instructions before and after the therapy. I have been instructed in and understand post treatment instructions and have received a printed copy of them. I understand that medicine is not an exact science and acknowledge that no guarantee has been given nor implied by anyone as to the results that may be obtained by this therapy. I also understand this procedure is elective and not covered by insurance. Therefore, payment is my responsibility. Any expense which may be incurred for medical care I elect to receive outside of this office, such as, but not limited to dissatisfaction of my therapy outcome will be my sole financial responsibility. Payment in full for all treatments is required prior to the time of service and is nonrefundable regardless of outcomes. I understand that to receive homologous allograft tissue therapy, I must comply with all stipulations outlined in this consent form. If I do not agree, I will not be able to proceed with treatment. I consent to the diagnosis, treatment plan, and regenerative cellular injection, after having been advised of alternative treatments, the known material risks of the diagnosis and therapy to be used, and the consequences if these diagnostic and therapeutic procedures were to be withheld or refused. I certify that I have read this entire document and understand this therapy agreement and that all blanks were filled in prior to executing my signature on the following page.

For Office Use Only

Procedure to be perfomed: Intra-articular joint injection(s)
CLINICIAN: I certify that I have explained to the patient the nature, purpose, anticipated benefits, material risks, complications, and alternatives to the treatment being delivered.

I have answered all questions fully. I believe the patient fully understands what I have explained.

Thank you for taking the time to fill out this form.

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