⚠️ California Required Notice
This facility performs procedures utilizing stem cells that have not yet been approved by the United States Food and Drug Administration. These therapies are not FDA-approved to treat, cure, or prevent any disease or condition. You are encouraged to consult with your primary care physician prior to undergoing any stem cell procedure.
FDA & Regulatory Disclosure
Stem cell therapies offered at LC Prime Regenerative are not approved by the U.S. Food and Drug Administration (FDA) to treat, cure, mitigate, or prevent any disease or medical condition. The cellular products used are classified as Human Cell and Tissue Products (HCT/Ps) and are regulated under 21 CFR Part 1271. All procedures are performed under the supervision of licensed medical professionals in compliance with applicable federal and state regulations. The use of these products for specific therapeutic indications is considered investigational and off-label.
No Medical Advice
The information presented on this website is for general informational and educational purposes only. Nothing on this website constitutes medical advice, diagnosis, or treatment recommendations. All content should be discussed with a qualified, licensed healthcare provider before making any medical decisions. LC Prime Regenerative does not establish a physician-patient relationship through this website or any marketing materials.
Individual Results & No Guarantees
Patient outcomes, testimonials, and case studies presented on this website reflect individual experiences and are not representative of results that all patients may achieve. Results vary significantly based on individual health conditions, age, lifestyle, treatment type, and other factors. No specific outcome, improvement, or result is guaranteed. Testimonials displayed are from actual patients but may not reflect the typical patient experience.
Insurance & Financial Disclosure
Stem cell and regenerative medicine therapies are generally considered investigational and experimental by most health insurance carriers and are not covered by Medicare, Medicaid, or private insurance plans. All treatment costs are the sole financial responsibility of the patient. Financing options, if available, are subject to third-party lender approval and independent terms. Promotional pricing is subject to change without notice and is valid only for the period specified at the time of inquiry. No refunds are guaranteed.
Cell Source & Product Disclosure
Mesenchymal stem cells (MSCs) used at this facility are sourced from donated human umbilical cord tissue (Wharton's Jelly) obtained through an FDA-registered tissue bank in compliance with 21 CFR Part 1271. All donors undergo a rigorous screening and testing process. Cell products are independently third-party tested for viability, sterility, and potency. LC Prime Regenerative does not manufacture, process, or store cellular products on-site. Products are provided through a partnership with The Stem Cell Club and supplied by an FDA-registered laboratory.
Risk & Safety Disclosure
As with any medical procedure, stem cell therapy carries potential risks and side effects including, but not limited to: infection at the injection site, allergic or immune reaction, fever, swelling, pain, bruising, and in rare cases, more serious adverse events. Patients with active cancer, severe immune disorders, certain infections, or other contraindicated conditions may not be eligible for treatment. A full medical evaluation will be conducted prior to any procedure to assess candidacy and minimize risk.
Off-Label Use Disclosure
The therapeutic use of mesenchymal stem cells (MSCs) for most conditions treated at this facility has not been evaluated or approved by the FDA for those specific indications. Physicians may legally prescribe or administer therapies in an off-label capacity based on their clinical judgment. Patients will be fully informed of the investigational nature of any treatment prior to providing informed consent. Participating in an unapproved therapy is entirely voluntary.
Research & Clinical Evidence
While mesenchymal stem cell therapy is the subject of extensive ongoing clinical research globally, the body of peer-reviewed evidence supporting its use for most specific conditions remains limited, preliminary, or inconclusive. References to scientific studies or research on this website are provided for informational context only and do not constitute an endorsement, validation, or guarantee of the therapies offered. LC Prime Regenerative does not conduct clinical trials.
Testimonial & Advertising Disclosure
Patient testimonials, reviews, videos, and success stories displayed on this website are provided voluntarily by actual patients. Per FTC guidelines, material connections or incentives provided in exchange for testimonials will be disclosed. Individual experiences do not constitute a guarantee or prediction of results. All advertising claims are intended to be truthful and non-misleading. This website has not been reviewed or approved by the FDA.
Pricing Disclosure
All prices displayed on this website are subject to change without prior notice. Quoted pricing reflects the base cost of a single treatment session and may not include additional fees for consultation, lab testing, imaging, follow-up visits, or ancillary services unless explicitly stated as all-inclusive. Any promotional pricing is time-limited and may be withdrawn at any time. Final pricing will be confirmed prior to treatment.
Privacy & HIPAA Notice
LC Prime Regenerative is committed to protecting your personal health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA). Information submitted through this website's contact or consultation forms is used solely for the purpose of responding to inquiries and scheduling consultations. We do not sell, rent, or share personal health information with third parties except as required by law or with your explicit consent. For our full Privacy Policy, please contact us directly.
Third-Party Partnership Disclosure
LC Prime Regenerative operates as a partner clinic of The Stem Cell Club and sources cellular products through that partnership. This affiliation does not constitute an endorsement by The Stem Cell Club of any specific treatment outcome. LC Prime Regenerative is independently owned and operated and is solely responsible for the care provided at its National City, CA location. Partnership pricing arrangements do not affect the quality or integrity of the products used.
