We operate strictly under FDA Section 361 guidelines for Human Cells, Tissues,and Cellular and Tissue-Based Products (HCT/Ps). To remain compliant and avoid being classified as a 'drug' (Section 351) requiring clinical trials, our product meets two critical criteria:

• Minimally Manipulated: The cells are not expanded, cultured, or enzymatically digested. They are harvested, separated, and cryopreserved.
• Homologous Use: We utilize the tissue for repair, reconstruction, and supplementation. Because Mesenchymal Stem Cells (MSCs) are derived from the mesoderm, and cartilage/ bone are mesodermal tissues, we argue this constitutes homologous use.

If you are in Florida,you are protected by specific legislation drafted by our team (Dr. Lurye and Lisa Spear). 

• Authorization: The law explicitly authorizes MDs and DOs to use these therapies for Orthopedics, Pain Management, and Wound Care. 
• Criminal Penalties for Non-Compliance: The law makes it a felony to use products from labs that do not have specific accreditations (AABB, AATB, etc.). This 'cleans up' the market and protects compliant doctors while penalizing those using 'bathtub lab' products. 
• National Implication: While this is a Florida statute, we are actively working on similar legislation in Arizona, Montana, and other states to create a national precedent.​
  

FDA enforcement largelytargets false advertising.​

• Do Not: Claim to 'cure' diseases (e.g., 'We cure Parkinson's' or 'Cure for Arthritis').
  
• Do: Market this as an 'alternative treatment modality' or 'regenerative therapy' for pain and inflammation.
  
• Informed Consent: Your consent forms must be transparent, stating that this is an off-label use of a biologic product.
  

Safety is our primary differentiator. We avoid labs that have received FDA Warning Letters (like some competitors). Our safety protocol includes: 

• The 'Big 4' Accreditations: Our manufacturing labs are accredited by the AABB (Association for the Advancement of Blood & Biotherapies), AATB (American Association of Tissue Banks), NMDP (National Marrow Donor Program), and WMDA. 
• Certificate of Analysis (CoA): Every vial comes with a report detailing the specific count of viable cells, confirming the absence of endotoxins, bacteria, mycoplasma, and viruses. 
• Post-Thaw Viability: Unlike older products that were dead upon arrival, our labs conduct post-thaw analysis to guarantee >90% cell viability at the time of injection.​
  

The risk is extremely low due to Immunologic Privilege.

• Umbilical cord-derived MSCs lack MHC Class II markers, meaning the recipient's immune system does not recognize them as foreign.
• There is no need for HLA matching (blood typing) between donor and host.

Dr. Lurye has performed thousands of these procedures. The 'Home Run' indications (high success rate) are:

• Knee Osteoarthritis: Significant reduction in pain and improved mobility.
• Shoulder & Hip: Labral tears and partial rotator cuff tears respond very well.
• Spine: Improvement in discogenic pain and reduction of inflammation in facet joints.

• Senescence (Aging): Stem cells from a 60-year-old patient are 60 years old. They have reduced regenerative potential.
• Apoptosis: Research suggests autologous (patient's own) cells injected into a new site often die within 48–72 hours due to environmental stress.
• Hypoxia Resistance: Umbilical cord cells are naturally adapted to low-oxygen environments.2 They are 'stress-resistant' and can survive in the joint/tissue for weeks to months, providing a sustained therapeutic effect.
  

While a portion of cells are sequestered in the lungs (pulmonary trap), they still exert a paracrine effect (releasing healing factors). Furthermore, the cells have a powerful Homing Response.

• They detect chemical signals (cytokines) released by inflamed tissue and migrate toward those sites.
• Dr. Lurye's Protocol: For severe cases, combine a local joint injection with an IV infusion (90–120 million cells) to lower total body inflammation, which helps the local injection work better.
  

This is a 100% cash-pay modality (insurance covers wound care in some contexts, but rarely orthopedics).

• Standard Knee Injection: ~$3,000 - $5,000 to the patient (depending on market).
• Cost Breakdown: You charge a Professional Fee (e.g., $1,500 for your time/ultrasound) + Facility Fee + Cost of Goods (Stem Cells).
  

• Ultrasound/Fluoroscopy: We strongly discourage 'blind' injections. You must be able to document accurate placement into the intra-articular space.
• Peer-to-Peer Support: Dr. Lurye offers direct mentorship to review your protocols, discuss difficult cases, and ensure you are confident in your injection technique.

Yes.

• PRP: We recommend compounding the stem cells with the patient’s own PRP (Platelet Rich Plasma) to provide a scaffold and additional growth factors.
• Hyperbaric Oxygen (HBOT): Using HBOT after injection can hyper-oxygenate the blood and increase the survival rate and activity of the injected stem cells.​