REGENERATIVE THERAPY CONSENT

Regenerative Therapy Consent
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Consent Form
 

 

AI WELLNESS CENTER OF EXCELLENCE

COMPREHENSIVE INFORMED CONSENT

REGENERATIVE THERAPIES CONSENT

Century City, California

Medical Director: Gideon Kwok, DO

1. PURPOSE OF THIS DOCUMENT

This Informed Consent provides a comprehensive explanation of the nature, risks, benefits, alternatives, and limitations of biologic and regenerative therapies offered at AI Wellness.

These therapies may include, but are not limited to:

  • Platelet-Rich Plasma (PRP)
  • Stromal Vascular Fraction (SVF)
  • Exosomes / Extracellular Vesicles
  • Wharton’s Jelly / Umbilical-derived products
  • Other autologous or allogenic biologics
  • Intravenous (IV) biologic administration

This document supplements your discussion with your provider and is intended to ensure your decision is fully informed, voluntary, and documented.

2. EXPERIMENTAL STATUS & FDA DISCLOSURE

I understand these therapies are NOT approved by the U.S. Food and Drug Administration (FDA) for the intended uses.

I understand these treatments are experimental, investigational, and/or off-label.

I understand these therapies are not considered standard medical care.

I understand that scientific evidence is limited, evolving, and may be inconclusive.

I understand these treatments are not intended to diagnose, treat, cure, or prevent any disease.

I acknowledge that no guarantees, warranties, or assurances have been made.

3. NATURE OF THE TREATMENT

Biologic and regenerative therapies involve the use of human-derived or patient-derived materials intended to support:

  • Cosmetic enhancement
  • Tissue repair and regeneration
  • Cellular signaling
  • General wellness and immune support

These therapies may be administered via:

  • Injection (intradermal, subdermal, intra-articular)
  • Microneedling or topical application
  • Intravenous (IV) infusion

I understand that mechanisms are not fully understood, outcomes are variable and unpredictable, and medicine is not an exact science.

4. ADVANCED REGENERATIVE DISCLOSURES

I understand that terms such as “stem cells” or “regenerative therapy” may be used broadly and products may not contain live stem cells.

I understand this field is rapidly evolving and controversial.

I understand that marketing, social media, or anecdotal claims may not reflect scientific evidence.

I confirm my decision is based on medical consultation—not marketing claims.

5. SOURCE OF BIOLOGICS & DONOR DISCLOSURE

Biologics may be autologous (my own) or allogenic (donor-derived).

Donor-derived tissues originate from consented human sources (including perinatal tissue such as umbilical cord/Wharton’s Jelly).

Donor screening may include testing for:

  • HIV I/II
  • Hepatitis B & C
  • HTLV I/II
  • Syphilis (RPR)
  • Additional infectious disease screening

I understand testing is performed by CLIA-certified laboratories and may comply with applicable FDA standards.

No current testing or processing technology can eliminate all risk of disease transmission, including known or unknown pathogens.

I understand biologic products may vary between batches, patients, and may not perform as expected.

I understand that neither AI Wellness nor its providers guarantee product sterility, biologic activity, potency, or clinical effectiveness.

6. RISKS, COMPLICATIONS & UNKNOWN FACTORS

Risks include, but are not limited to:

Common:

  • Pain, swelling, bruising
  • Redness, irritation
  • Temporary discomfort

Moderate:

  • Infection
  • Allergic or inflammatory reactions
  • Nerve irritation
  • Vascular complications

Serious / Rare:

  • Immune dysregulation
  • Tissue damage or necrosis
  • Transmission of infectious disease
  • Fibrosis or abnormal healing
  • Theoretical tumor stimulation
  • Permanent nerve injury

Additional Procedural Risks:

  • Injury to adjacent tissues, tendons, or nerves
  • Bleeding or hematoma
  • Worsening of symptoms
  • Unsatisfactory cosmetic outcome

IV-SPECIFIC RISKS

I understand IV administration introduces systemic exposure and increased risk.

  • Infection or sepsis
  • Anaphylaxis
  • Cardiovascular complications
  • Pulmonary complications
  • Thromboembolic events
  • Organ dysfunction
  • Hospitalization or death (rare)

I understand long-term systemic risks are unknown.

CRITICAL ACKNOWLEDGMENT

I understand unknown risks may exist and outcomes may include no improvement, temporary improvement, worsening condition, or unexpected complications.

7. NO GUARANTEE OF RESULTS

I understand results are not guaranteed and may be temporary, minimal, or absent.

8. ALTERNATIVES

Alternatives include no treatment, standard care, surgical intervention, or medications.

9. MEDICAL DISCLOSURES

I have disclosed all medical conditions, medications, and supplements.

I am not pregnant or breastfeeding.

I do not have an active or known infection.

10. FINANCIAL RESPONSIBILITY

This is an elective, cash-pay treatment. Insurance does not cover this procedure.

All payments are non-refundable, and I accept financial responsibility for complications and additional care.

11. ASSUMPTION OF RISK & LIABILITY RELEASE

I voluntarily elect this treatment, understand it is experimental, and accept all risks.

I assume full responsibility and agree AI Wellness and its providers are not liable for outcomes.

12. PROCEDURAL AUTHORIZATION

I authorize the provider to perform the procedure(s) discussed and any necessary additional procedures.

13. ANESTHESIA

I may receive anesthesia and will not operate machinery if impaired.

14. EMERGENCY CARE

I understand AI Wellness is not a hospital and consent to emergency transfer if needed.

15. CALIFORNIA LEGAL DISCLOSURES

I understand this treatment is not standard medical care and my consent is voluntary.

16. ARBITRATION AGREEMENT

I agree to binding arbitration and waive the right to a jury trial in Los Angeles County, California.

17. LIMITATION & SEVERABILITY

If any portion of this agreement is invalid, the remainder remains enforceable.

18. DATA, PHOTOGRAPHY & AI PLATFORM

☐ Consent to treatment data tracking

☐ Consent to photography/video for documentation

☐ Consent to / ☐ decline use for education/marketing

19. COMPLIANCE & POST-CARE RESPONSIBILITY

I agree to follow all instructions and understand non-compliance may increase risk and affect results.

20. FINAL ACKNOWLEDGMENT

I confirm I have read and understand this document, accept all risks, and voluntarily proceed.