Consent to Treat – Stem Cell & Exosomes

Informed Consent for Allogeneic Perinatal Stem Cell Transplantation


The undersigned patient/guardian does hereby acknowledge and confirm that they have received a consultation regarding Intravenous/ Intra-articular/ Local tissue Stem Cell Therapy and that this consultation shall not serve in any capacity as a replacement for consultation with their primary care physician/provider. The consultation is to discuss, without guarantee, the possibility that the infusion/injection therapy could provide some therapeutic benefit to the patient. The patient/guardian is advised and understands that this procedure is not yet FDA-approved, and still considered experimental in nature. The recommendation(s) made by the consultant are not a substitute for the services and counseling made available to the patient and the patients primary care physician/clinic and/or specialist physician. It is further understood that the program designed for you, including any procedures or modalities (such as intravenous nutritional therapies) are not to be construed as treatments or remedies to diagnose, treat, cure, or prevent any disease or injury.It is the consultant’s obligation 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. The following procedure has been recommended: Upon your authorization and consent, this Intravenous/ Intra-articular/ Local tissue Stem Cell Therapy will be performed on you by a medical doctor. 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. This infusion/injection of human tissue product can carry a risk of infectious disease transmission even though every possible precaution has been made to prevent such. 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.

As the patient (I) you consent to these:

I understand that alternative treatments are available, and I understand the advantages and disadvantages of the proposed stem cell therapy. I am advised that although good results are the norm and expected, there is no guarantee, expressed or implied, as to the success of the treatment. There is always a possibility that I will have a result not meeting my expectations.

I understand that I have been informed that there have been reports of tumor-promoting potentials of stem cell treatment, and that I hereby confirm that I do not have any active form of cancer in my knowledge. If I do have a significant family history of cancer, recent cancer that has since been in remission, or that I have active cancer, I still choose to pursue stem cell treatment despite being full informed. I hereby relieve the treating physician of any and all liabilities if cancer emerges in the future or current cancer worsens.

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