Informed Consent

About This Consent

This Informed Consent document is part of the 5DGENX patient onboarding process. It must be reviewed, understood, and electronically signed before any prescription product or treatment is fulfilled.

This is not a substitute for the specific informed consent forms you will be asked to sign for individual treatments or programs. Each program has its own consent document tailored to the specific therapy.

Nature of Treatment

5DGENX provides physician supervised regenerative medicine programs, including:

• Mesenchymal stem cell therapy (umbilical cord derived)
• Exosome therapy
• Compounded peptide protocols
• Laboratory diagnostics
• Cellular recovery support products

Specific treatment details, including dosing, frequency, and duration, will be determined by your prescribing physician based on your clinical evaluation.

Expected Benefits

Patients enroll in 5DGENX programs for various reasons including:

• Joint and tissue recovery support
• Athletic performance and recovery
• Cognitive function support
• Metabolic and hormonal optimization
• Longevity and healthspan focus

Outcomes vary by individual. No specific clinical result is guaranteed. Your response to treatment may differ from published research, marketing materials, or other patients' experiences.

Known Risks

All medical treatments carry risks. Risks specific to regenerative medicine, compounded peptides, and injectable therapies include but are not limited to:

Stem Cell and Exosome Therapy

• Injection site reactions (pain, swelling, bruising, infection)
• Allergic reactions
• Temporary increase in pain or inflammation
• Lack of expected therapeutic effect
• Unknown long term effects

Compounded Peptide Protocols

• Injection site reactions
• Headache, nausea, fatigue
• Hormone fluctuations
• Mood changes
• Allergic reactions
• Unknown long term effects (peptides are not FDA approved for most uses)

Laboratory Procedures

• Bruising at venipuncture site
• Fainting or dizziness
• Rarely, infection

Specific risks for your program will be detailed in the program specific consent document you will sign before treatment.

Alternative Options

Alternatives to 5DGENX programs include:

• Conservative management with your primary care physician
• FDA approved pharmaceutical treatments for your condition
• Physical therapy and lifestyle modification
• In person specialist consultation
• Choosing not to pursue treatment

You acknowledge that you have considered these alternatives and choose to proceed with 5DGENX programs.

Acknowledgment of Compounded Products

You acknowledge and understand that:

• Many 5DGENX products are compounded by licensed 503A pharmacies and are not FDA approved
• Compounded medications do not undergo the FDA new drug approval process
• Compounded medications are prepared for individual patients based on physician prescription
• Statements about benefits have not been evaluated by the FDA
• You are accepting these limitations as part of your treatment

Stem Cell Therapy Disclosure

If you are enrolling in a stem cell program, you understand and acknowledge:

• Mesenchymal stem cell therapy and exosome therapy are not FDA approved for the treatment of any specific disease in the United States
• Outcomes vary by individual
• The therapy may not provide the expected benefit
• Specific delivery details, including location of care and clinical environment, will be communicated to you before treatment
• You have had the opportunity to ask questions about the therapy and have received satisfactory answers

Your Rights

You have the right to:

• Ask questions before, during, and after treatment
• Withdraw consent and discontinue treatment at any time
• Seek a second opinion
• Access your medical records
• Receive a copy of this consent and any program specific consent forms
• Be treated with respect and dignity

Patient Acknowledgment

By signing this Informed Consent (electronically as part of your patient onboarding, or as a written signature when required), you acknowledge that:

• You have read and understood this document
• You have had the opportunity to ask questions and have received satisfactory answers
• You understand the nature, benefits, risks, and alternatives of 5DGENX programs
• You understand that many products are compounded and not FDA approved
• You consent to participating in 5DGENX programs
• This consent is given freely and without coercion

You can withdraw consent at any time by contacting [email protected] or your assigned physician.

Questions

For questions about this Informed Consent or about a specific program's consent requirements: