MDI Medical Group PC’s Informed Consent for Peptide Therapy

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This document is intended to inform patients of MDI Medical Group and its affiliated medical practices (“MDI”) of important information regarding their care. Please carefully read this document ask the provider any questions before commencing treatment. All patients must sign and date this consent before commencing any peptide therapy.

I understand that peptides are small chains of amino acids linked together that can bind to receptors of the cells in the body. They act as signaling agents to instruct the cells to accomplish various specific functions. The goals of this therapy are to try and prevent, reduce or control the dysfunctions associated with the aging process, through hormonal balancing, control of oxidative stress, and other clinically significant therapeutic agents.

Goals of Treatment:

Each peptide has its specific effect and function on the body. My MDI provider (the “Provider”) will provide me with information on my specific peptide therapy in an addendum to this Consent.

Risks of Peptide Therapy:

All peptide prescribing is clinician directed. Common side effects include reactions at the injection site, such as pain, redness or swelling along with flushing of the face; less than 1% of patients report dizziness, headache, heart palpitations or hyperactivity. Allergic reactions might occur in sensitive individuals. My Provider will provide me with information on risks of my specific peptide therapy in an addendum to this Consent.

Contraindications:

Most peptides should not be used in patients with cancer. Other precautions might apply to my personal case and should be discussed with my MDI Provider.

I have received enough information about these treatment goals and risks to make my decision to start the treatment. I understand that my provider will monitor my treatment in an effort to prevent adverse reactions but cannot guarantee that I will not experience any side effects to the treatment. I understand that, as with any health treatment, there is no guarantee that I will obtain satisfactory results through the use of this therapy. I understand that the use of this treatment does not preclude me from using other treatments as well.

By providing my signature on the intake questionnaire I acknowledge that I understand and agree with the following:

I hereby consent to receiving peptide therapy treatment. I understand that while I may expect the anticipated benefits from peptide therapy treatment, no results can be guaranteed or assured.
I have sufficient information to give this informed consent. I further acknowledge that I understand that compounded peptides are not approved by the FDA for any particular indication.
I have informed my provider of any known allergies to drugs or other substances, and of any past reaction to injections. I have also informed my provider of all current medications and supplements.
I understand that certain members of the medical community may consider peptide therapy new, controversial, medically unnecessary and/or experimental. I acknowledge that the risks involved and the possibilities of complications have been explained to me.
I understand that I will be responsible for injecting or administering the medications prescribed to me. I agree to comply with the recommended treatment and therapy as prescribed, and consent to periodic monitoring, when requested, which may include laboratory tests or screening evaluations. I acknowledge that I assume full liability for any adverse effects that may result from the negligent administration of any proposed treatment, and waive MDI and all MDI Providers from any claim in law or equity for redress of any grievance that I may have concerning or resulting from the negligent administration of any proposed treatment.
I agree to inform my MDI Provider of any new physical symptoms or any medical conditions that may develop before or while I am undergoing peptide therapy treatment.
I agree to comply with all other healthy lifestyle activities that have been individually recommended for me. I certify that I have disclosed to my MDI Provider my complete medical history, including prescription and non-prescription medications that I am currently taking or plan to take during peptide therapy treatment, as well as any other over-the-counter medications, recreational drugs or social substances, herbs, extracts, and other dietary supplements.
I certify that I am under the care of other provider(s) for all other medical conditions, and will continue under the care of my other provider(s) for any on-going medical conditions outside of peptide therapy treatment. I understand that it is my responsibility to communicate with my other provider(s) about my peptide therapy treatment with MDI, including providing such provider(s) a copy of my medical records as may be required by applicable state law.
I understand that I have the right to suspend or terminate treatment at any time by notifying MDI and my MDI Provider of any such suspension or termination.

I have read this document carefully and understand the risks and goals of peptide therapy treatment and have had my questions regarding the services explained and I hereby give my informed consent to receive such treatment under the terms described herein.

CONSENT ADDENDUM FOR BPC-157

Overview: BPC-157 (Body Protection Compound 157) is a synthetic, laboratory-made peptide consisting of 15 amino acids. It is a partial sequence derived from a protein found naturally in human gastric juice.

Therapy Goals: Potential goals of this peptide therapy are:

Recovery
Tissue repair
Anti-inflammatory and immune support

Risks of Therapy: I understand the possible risks associated with this treatment. Common side effects of BPC-157 include reactions at the injection site, such as pain, redness or swelling. Allergic reactions to the peptide can occur, although rare. I will report any potential side effects to my provider as soon as they might occur.

I understand and have been advised that I should not receive BPC-157 if I have the following conditions: pregnancy or lactation, psychiatric diseases, misusing or dependency on any drug, hepatic or renal dysfunction, cancer, diabetes, systemic infections or inflammatory diseases, or serious cardiovascular condition.

Nature of Treatment: I understand that I will be in charge of administering the prescribed drug and will conform to the recommended dosages and methods of administration provided by my provider. The drug provided to me may be a compounded drug provided by a state-licensed pharmacy.

Alternatives: I understand that, as with any health treatment, there is no guarantee that I will obtain satisfactory results through the use of this therapy. I understand that there are alternative treatment options for my condition that my provider will discuss with me, such as other prescription medications. This informed consent addendum is in addition to MDI’s standard informed consent and financial forms; this document does not revise or amend the terms of those documents in any way.

Acknowledgements: I understand that this form has been fully explained to me, that I have read it or have had it read to me and that I understand its contents. I have been given the opportunity to ask questions about my condition, the medication to be used and the risks and side effects involved, as well as alternative treatments.

I have sufficient information to give this informed consent. I further acknowledge that I understand this drug is not approved by the FDA for any particular indication.

CONSENT ADDENDUM FOR KPV

Overview: KPV is a naturally occurring tripeptide—one of the smallest biologically active peptides studied—consisting of just three amino acids: lysine, proline, and valine. The main research areas are inflammatory bowel disease (particularly ulcerative colitis), inflammatory skin conditions (dermatitis, psoriasis, wound healing), and antimicrobial applications. All research to date is preclinical — conducted in cell cultures and animal models — with no completed human clinical trials.

Therapy Goals: Potential goals of this peptide therapy are:

Anti-inflammatory support
Gastrointestinal support
Antimicrobial activity support

Risks of Therapy: I understand that some potential risks and side effects include nausea, flushing, blood pressure changes hyperpigmentation and injection site reactions or nasal irritation (as applicable to the route of administration). I will report any potential side effects to my provider as soon as they might occur. I should not take KPV if I have an allergy to any of its components, or have a history of cancer. I should also avoid KPV if I am pregnant, breastfeeding, or planning to become pregnant.

Nature of Treatment: I understand that I will in charge of administering the prescribed drug intranasally and will conform to the recommended dosages and methods of administration provided by my provider. The drug provided to me may be a compounded drug provided by a state-licensed pharmacy.

Alternatives: I understand that, as with any health treatment, there is no guarantee that I will obtain satisfactory results through the use of this therapy I understand that there are alternative treatment options for my condition that my provider will discuss with me, such as other prescription medications. This informed consent addendum is in addition to MDI’s standard informed consent and financial forms; this document does not revise or amend the terms of those documents in any way.

I have sufficient information to give this informed consent. I further acknowledge that I understand this drug is not approved by the FDA for any particular Indication.

CONSENT ADDENDUM FOR TB-500/THYMOSIN BETA 4

Overview: TB-500 is a synthetic peptide that mimics the active region of thymosin beta-4, a 43-amino-acid protein naturally produced in nearly every cell in the human body. It is widely studied for its ability to promote cell migration, new blood vessel formation, and tissue repair, and it is used as a research compound to support recovery from soft-tissue injury, joint damage, and chronic wounds.

Therapy Goals: Potential goals of this peptide therapy are:

Soft tissue injury and tendon recovery
Chronic wound and skin healing
Joint pain and overuse injuries
Cardiac repair after injury
Eye and corneal healing
Hair and skin regeneration

Risks of Therapy: I understand that some potential risks and side effects include dizziness, fatigue and injection site reactions or nasal irritation (as applicable to the route of administration). I will report any potential side effects to my provider as soon as they might occur. I should not take TB-500/Thymosin Beta 4 if I have an allergy to any of its components, a history of cancer or autoimmune disease. I should also avoid TB-500/Thymosin Beta 4 if I am pregnant, breastfeeding, or planning to become pregnant.

Alternatives: I understand that, as with any health treatment, there is no guarantee that I will obtain satisfactory results through the use of this therapy. I understand that there are alternative treatment options for my condition including, but not limited to, diet and exercise, surgical interventions, and other prescription drugs. This informed consent addendum is in addition to MDI’s standard informed consent and financial forms; this document does not revise or amend the terms of those documents in any way.

I have sufficient information to give this informed consent. I further acknowledge that I understand this drug is not approved by the FDA for any particular indication