Regenerative Procedure Disclosure
1. Scope of procedures
This disclosure covers all autologous regenerative procedures offered by Vita Health 365. "Autologous" means these procedures use your own tissue, such as blood drawn from your arm, which is then processed and applied during the same visit. The tissue is minimally manipulated and is not combined with drugs or other biological products.
These procedures are physician-determined. Your clinician will evaluate whether you are a candidate based on your medical history, physical examination, and the available clinical evidence for your specific condition.
2. What we offer
Vita Health 365 currently offers the following autologous procedures in select indications:
- PRP for orthopedic indications. Platelet-rich plasma (PRP) may support recovery in select cases of chronic tendinopathy, mild-to-moderate joint discomfort, and as an adjunct to other orthopedic interventions. PRP is used in select indications where the physician determines it is clinically appropriate.
- PRP for aesthetic indications. PRP may be used in select aesthetic applications, including physician-determined scalp and skin procedures. These procedures are elective and are not medically necessary.
All procedures are performed in person at our California location by a licensed physician or under direct physician supervision.
3. What we do not offer
Vita Health 365 does not offer regenerative procedures for:
- Systemic diseases or conditions affecting the whole body.
- Neurological conditions, including but not limited to Parkinson's disease, multiple sclerosis, or spinal cord injuries.
- Autoimmune disorders.
- Oncology or cancer-related conditions.
- Cardiovascular disease.
- Any condition for which regenerative procedures are not supported by peer-reviewed evidence or where the risk-benefit profile is unfavorable.
We do not claim that any of our procedures can replace standard medical or surgical treatment for these conditions. Patients who present with these conditions will be referred to appropriate specialists.
4. Evidence transparency
We believe you deserve honest information about the state of the evidence for these procedures.
- Autologous PRP procedures are supported by a growing body of peer-reviewed literature for certain orthopedic and aesthetic indications. However, the evidence is still developing and is not yet conclusive for all applications.
- Results vary from patient to patient. Published studies show a range of outcomes, and individual results depend on many factors, including the specific condition, the patient's overall health, and other variables.
- These procedures are not FDA-approved treatments for any specific disease or condition. The FDA regulates the devices used to prepare PRP but does not approve PRP itself as a drug or biologic for specific indications.
- We will provide you with references to relevant clinical literature upon request so that you can make an informed decision.
5. Risks
As with any medical procedure, autologous regenerative procedures carry risks. These may include but are not limited to:
- Pain, swelling, or bruising at the treatment site or blood draw site.
- Infection, though the risk is low with proper sterile technique.
- Nerve or tissue injury at the injection site.
- Allergic reaction to materials used during the procedure (such as antiseptic solutions).
- No improvement in symptoms. These procedures may not work for every patient.
- Worsening of symptoms in rare cases.
- Risks associated with the blood draw itself, including lightheadedness, bruising, or fainting.
Your clinician will discuss these risks with you in detail before any procedure and answer any questions you have.
6. Consent process
Before any regenerative procedure, you will be asked to sign a written informed consent form. This form will be presented to you in no smaller than 14-point bold type, as required by California law.
The consent form will include:
- A clear description of the proposed procedure.
- The expected benefits and the fact that outcomes are not guaranteed.
- The known risks and possible side effects.
- Alternative treatments available to you, including the option of no treatment.
- A statement that the procedure is not FDA-approved for any specific disease.
- Your right to ask questions and to take time before making a decision.
You will have the opportunity to review the consent form, ask questions, and discuss it with your physician before signing. You will not be pressured to sign on the same day as your consultation if you need more time.
7. Patient rights
You have the right to:
- Withdraw your consent at any time before the procedure begins, without penalty and without affecting your access to other services.
- Receive a clear explanation of the procedure, risks, benefits, and alternatives in language you understand.
- Request interpreter services if English is not your primary language.
- Ask for references to published clinical studies related to your proposed procedure.
- Seek a second opinion from another provider before proceeding.
- Receive a copy of all consent documents you sign.
8. Follow-up protocol
After any regenerative procedure, Vita Health 365 follows a structured follow-up plan:
- You will receive written post-procedure instructions, including what to expect, activity restrictions, and warning signs that require medical attention.
- A follow-up visit (in person or via telehealth) will be scheduled within [7-14] days of the procedure to assess your recovery.
- Additional follow-up visits may be scheduled at 4 weeks, 8 weeks, and 12 weeks depending on the procedure and your progress.
- If you experience any unexpected symptoms after the procedure, you should contact us immediately. For medical emergencies, call 911.
9. Complaints
If you have concerns about the care you received or believe that this disclosure was not properly followed, you may:
- Contact us directly at hello@vitahealth365.com.
- File a complaint with the Medical Board of California at mbc.ca.gov/complaints.
- File a complaint with the California Department of Public Health.
10. Contact
If you have questions about this disclosure or our regenerative services, please contact us:
Legal: hello@vitahealth365.com
HIPAA Compliance: hello@vitahealth365.com
Mailing: Vita Health 365, 2064 Marengo St, Suite 600, Los Angeles, CA 90033