Consent Form
I hereby volunteer to serve as a patient to demonstrate specific procedures associated with a field of medicine known as "regenerative medicine."
I specifically request and authorize _________________________ to arrange for the provision of regenerative medicine products and procedures to me in an educational setting to instruct licensed healthcare professionals on the proper administration (e.g., injection) of regenerative medicine products and procedures; I further understand and agree that the Food and Drug Administration generally characterizes such regenerative medicine products and procedures as experimental, and I understand and agree that none of these regenerative medicine products or procedures are reimbursable by any health insurance. As such, I agree not to submit claims to any such insurer for or in connection with the regenerative medicine products or procedures I desire to receive.
By signing below, I agree to receive the following experimental products and procedures:
WHARTON'S JELLY ALLOGRAFT (includes Growth hormones, growth factors, and stem cells).
ALLOGENIC UMBILICAL CORD BLOOD ALLOGRAFT DEPLOYMENT (includes growth factors, growth hormones, and stem cells).
AUTOLOGOUS BONE MARROW ASPIRATE DEPLOYMENT (includes growth hormones, growth factors, and stem cells).
ALLOGENIC AMNIOTIC TISSUE ALLOGRAFT DEPLOYMENT (includes growth factors, growth hormones, and stem cells).
EXOSOME DEPLOYMENT _____
PRP (Platelet Rich Plasma) or PRF (Platelet Rich Fibrin)
I understand that many people may benefit from autologous and/or allogeneic cell therapy for various medical problems. Recent medical studies have shown that cell therapy can help some subjects. Regenerative Biological solutions from Wharton's Jelly tissue, bone marrow, umbilical cord blood, and amniotic fluid contain adult mesenchymal stem cells. My receipt of such products and services entails deploying Regenerative Biological solutions to candidates who meet the other medical screening criteria that have been generally established
I have been given plenty of opportunities to ask questions about this information. Before signing, I have been further offered to take this form home for consideration (including to my legal counsel). I take full responsibility for disclosing my complete and accurate medical history and complying with all pertinent treatment and monitoring programs. I understand that by failing to disclose my medical history and conditions thoroughly, obtain recommended testing, and adhere strictly to the protocol, I could be exposed to severe medical risks, including cancer, disability, and death. I am not a candidate for Regenerative Biological solutions deployment if I have actively growing cancer; I take full responsibility for making such disclosures to the treating office before receiving any products or services. I understand and agree that my receipt of regenerative medicine products and services will be observed for educational purposes. I further understand and agree that the provider may use images of my treatment for commercial purposes, and I hereby consent to such.
OSSIBLE BENEFITS
The potential benefits of Regenerative Biological solutions deployment for eligible patients may include improving certain chronic degenerative diseases. Although some benefits often occur, some patients will experience all of them, some will experience some of them, and some patients will be non-responders and not experience any of them. Also, the degree of benefit varies. The long-term effects of Regenerative Biological solutions deployments are unknown.
POSSIBLE RISKS OR DISCOMFORT
he potential risks of Regenerative Biological solutions deployment include, but are not limited to complications of bone aspirations (bleeding, bruising, discomfort, infection, scar, unwelcome cosmetic effects, reaction to local anesthesia, damage to internal organs), local reactions to intravenous infusion of Regenerative Biological solutions (you may experience pain, bruising, vein thrombosis, swelling, hematoma, or bleeding at the puncture site), side effects of intraarterial injection of Regenerative Biological solutions, (such as embolization, "clots", damage to arteries and organs, immediate or delayed uncontrolled bleeding from the puncture site are all conceivable possibilities), allergic reaction to DMSO preservatives up to and including death, side effects of intra-venous injections of Regenerative Biological solutions (such as joint pain, swelling, bleeding, infection), side effects of Regenerative Biological solutions injection into the spine, Host vs. Graft disease, embolism from extraction site, including epidural space and cerebrospinal fluid space, and side effects of Regenerative Biological solutions injection into soft tissue (such as swelling, pain, bleeding, or damage to nerves or internal organs). There are also unknown long-term effects of autologous and/or allogenic Regenerative Biological solutions therapy. Other possible risks could include potentially harmful reactions to resuscitative medications or measures (chest compressions, electrical shock, CPR in general, and/or call 911) if a life threatening reaction is encountered and requires treatment. If you experience an adverse reaction after you return home, please contact the office where you were treated and discuss it with the doctor. The doctor may consult other professionals to discuss your reaction.
If you have an active tumor or cancerous tumor that is present, but you are unaware of its existence, we do not know how it would be affected - it could conceivably be made more aggressive. I agree to be wholly and entirely responsible for disclosing any information concerning my active or cancerous tumor to my provider (before treatment).
AVAILABLE TREATMENT ALTERNATIVES
Many diseases being treated by Regenerative Biological solutions deployment may be relieved by other means, and my medical provider can discuss these with me. Some symptoms may resolve naturally without medical intervention. Even if I am a Regenerative Biological solutions deployment candidate, I may experience no improvement and, therefore, would not be harmed by not receiving the deployment. I have been fully informed about the effects and nature of autologous or allogenic Regenerative Biological solutions deployment, the risks involved, the possible complications, and the possible consequences and alternatives. I have been given information about the proposed procedure. I have been allowed to ask questions concerning the procedure type and fully understand the responses. It is my responsibility to read these and abide by the recommendations.
RIGHT TO TRY AND COMPASSIONATE USE DISCLOSURE
I acknowledge that I have been informed that the regenerative medicine products and procedures I have elected to receive may not be approved by the U.S. Food and Drug Administration (“FDA”) and may fall under investigational or experimental classifications. Some of the products or services may qualify for access under the federal Right to Try Act of 2017 (Pub. L. No. 115–176) or the Florida Right to Try Act (Section 499.0295, Florida Statutes), as well as the Compassionate Use pathway authorized by the FDA for patients with life-threatening or serious conditions who have exhausted approved treatment options. By signing this consent form: - I acknowledge that I have been informed of my right to request access to eligible investigational treatments under the federal Right to Try Act or the FDA’s Expanded Access (Compassionate Use) Program. - I understand that the regenerative medicine procedures being provided to me are not FDA approved for the specific indications for which they are being used, and that safety and efficacy data may be limited. - I voluntarily consent to receive these treatments, recognizing that their long-term effects, risks, and benefits may be unknown or unpredictable. - I confirm that I have had the opportunity to ask questions about these investigational therapies and have received sufficient information to make an informed decision.
FLORIDA STEM CELL THERAPY DISCLOSURE – HB 1617 (2025) NOTICE TO PATIENT THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.
PATIENT ACKNOWLEDGMENT AND CONSENT I acknowledge that: 1. The stem cell therapy I am electing to receive is not approved by the United States Food and Drug Administration (FDA). 2. The therapy is intended for treatment related to orthopedics, wound care, or pain management, which are within the scope of practice for the health care provider. 3. The stem cells used in this therapy: a. Are manufactured in a clean room space certified by the FDA for using high-efficiency particulate air (HEPA) filtration or ultra-low penetration air (ULPA) filtration to minimize contamination. b. Are retrieved, manufactured, and stored in a facility that is registered and regulated by the FDA and licensed or registered with one of the following entities: - National Marrow Donor Program - World Marrow Donor Association - Association for the Advancement of Blood and Biotherapies - American Association of Tissue Banks 4. The therapy does not involve the use of stem cells derived from aborted fetuses or adiposederived mesenchymal stem cells for transplantation. 5. The health care provider will adhere to applicable current good manufacturing practices as outlined in 21 C.F.R. part 1271 during the performance of the therapy. 6. I have received and read the above NOTICE TO PATIENT. 7. I have been informed of the nature and character of the proposed treatment, its FDA approval status, anticipated results, recognized possible alternative forms of treatment, and the recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment. 8. I have had the opportunity to ask questions and have received satisfactory answers. 9. I voluntarily consent to receive the stem cell therapy as described.
FINANCIAL CONSIDERATIONS I have been informed that my Regenerative Medicine deployment is not covered by health insurance, and therefore, I am responsible for the cost of the product(s) and procedure(s). I authorize the Medical providers to employ assistants, nurses, physicians, radiologists, anesthesiologists, and/or technologists necessary for the procedure and approve their participation. I also authorize the treating physician to perform any other procedures he or she may deem necessary or desirable to improve the conditions encountered during the procedure. You must be advised that we will provide resuscitative procedures in case of an emergency. I For women: Regenerative Biological solutions deployment represents potential unknown risks to pregnant women or those who may become pregnant after deployment. There are also unknown risks to an embryo or fetus. Anesthesia that accompanies this procedure may be harmful to an unborn baby. If you have had a hysterectomy or are post-menopausal, you are excluded from having to take a pregnancy test. Medical providers will provide you with a pregnancy test before the procedure. All that is required is a small amount of urine. The medical provider has advised me to undergo a pregnancy test before my treatment. I am declining to submit to such a test and am certain I am not pregnant. Therefore, I waive any claim against any medical provider should I unexpectedly find myself to be/have been pregnant during my procedure. I also understand that I have the right to request a pregnancy test after signing this Informed Consent. I know the practice of medicine and surgery is not an exact science; therefore, reputable practitioners cannot correctly guarantee outcomes. I acknowledge that no guarantee or assurance (expressed or implied) has been made by anyone regarding the Experimental Regenerative Biological solutions deployment procedure that I have herein requested and authorized. Once treatment has started, no refunds will be given. By signing this Consent, I acknowledge that I (1) read this form (or it was read to me) carefully, (2) asked any question that I wished, and (3) received satisfactory answers to my questions and requests for additional information, (4) will disclose my medical history and conditions truthfully and entirely to the practice, and (5) will inform the practice promptly of any change in my health or symptoms or any complication of treatment. (6) Voluntarily agree to participate in the research protocol. I further agree to indemnify and hold medical providers harmless with respect to any cost, claims, damages, or expenses (including attorneys fee) that may incur in connection with (a) a breach by me of any of the terms of this Consent, and (b) any adverse or undesirable outcome of any kind in connection with my receipt of any products or services generally or specifically described in this Consent. I will receive a copy of this signed and dated Consent sent to my email address on file.
Dated: Signature of Patient or Legal Guardian giving Informed Consent: Signature: ________________________________________________________ Name: ___________________________________________________________ Address: _________________________________
City: _____________________________________ State: ________ Zip: ____________ Mobile Phone: __________________________________________________ Email: ________________________________________________________ Witness Signature: Witness Name: __________________________
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