Frequently Asked Questions
FDA REGULATORY
Is regenerative medicine FDA approved or regulated?
EXPECTATIONS
The FDA regulates the manufacturing of biologics but does not 'approve' the practice of medicine. Our therapies utilize products compliant with Section 361 (minimal manipulation), which are legal but classified as experimental. We prioritize full transparency regarding this distinction.
What is the '80/15/5 Rule' for patient outcomes?
We adhere to clinical honesty: roughly 80% of patients reach their clinical goals, 15% experience partial improvement, and 5% are non-responders. Success depends on the severity of the condition and the patient's individual biological ability to heal.
QUALITY STANDARDS
What are 'live cells' versus a cellular 'graveyard'?
CLINICAL FUNCTION
Many commercial products are over-processed, resulting in a 'graveyard' of dead cellular debris with zero signaling power. We only utilize high-viability, live cellular products that retain the functional power required to activate the paracrine signaling cascade.
Do the cells act as 'managers' or 'builders'?
In regenerative medicine, MSCs typically act as 'construction managers.' They use paracrine signaling to release exosomes and peptides that command your body's resident cells to repair tissue, reduce inflammation, and promote new blood flow (angiogenesis).
PRODUCT POTENCY
What is the 'Sixth Passage Rule' in lab culture?
RECOVERY
When cells are expanded in a lab, they lose potency with every doubling (passage). After six passages, cells typically lose their therapeutic identity. We strictly use low-passage products to ensure the biological activity is at its peak when delivered.
What is the expected healing timeline?
Biological repair takes time. While initial anti-inflammatory relief often occurs within 3-6 weeks, the total structural healing and tissue maturation process continues for 6 to 8 months. Patience is required for long-term regenerative restoration.
PATIENT SAFETY
Is there a risk of tumors or cancer?
INSURANCE & FINANCE
Mesenchymal Stem Cells (MSCs) are non-tumorigenic, meaning they do not form teratomas unlike embryonic cells. Extensive clinical research and history support that modern regenerative therapies do not stimulate tumor growth in treated tissues.
Why isn't this covered by my insurance?
Despite thousands of clinical trials, major insurers still classify regenerative medicine as 'experimental' or 'elective.' We offer flat-fee transparent pricing to avoid hidden medical billing and ensure your resources go directly toward high-quality care.