What are Human Cells and Tissue Products (HCT/P)?

These are minimally manipulated, DMSO- free, cryogenically preserved human birth tissue allografts derived from the umbilical cord. Thes structural tissues contain both extracellular matrix, such as elastin, Hylauronan, collagen fibers, and fibronectin, and naturally occurring tissue components such as growth factors, cytokines, and nanoparticles. These products are regulated solely under section 361 of the PHS Act and the regulations in 21 CFR 1271

What is a structural tissue?

Tissues that physically support or serve as a barrier or conduit, or connect, cover or cushion in the donor are generally considered structural tissues, for the purposes of determining the applicable regulatory definition. Examples of structural tissues include: bone, skin, amniotic membrane, umbilical cord, blood vessel, adipose, cartilage, tendon, and ligaments.

What are the meaningful characteristics of structural tissue?

Structural tissue’s utility for reconstruction, repair, and replacement uses its relevant characteristics such as strength, flexibility, cushioning, and compressibility.

Do these structural tissues contain cells?

Structural tissue may contain both extracellular matrix and cellular components because any alteration of these components that relates to the tissue’s utility for reconstruction, repair or replacement would be considered more than minimal manipulation.

What is minimal manipulation?

For structural tissue, minimal manipulation is processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair or replacement.

What is homologous use?

Homologous use means the reconstruction, repair, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient. Recipient’s cells or tissues may or may not be identical to the donor’s cells or tissues but do perform one or more of the same basic functions in the recipient cells and tissues as performed in the donor.

Quality Assurance:

These tissue products are processed from bio-ethically donated human birth tissue from healthy, consenting mothers in the United States who have passed a comprehensive medical background check, blood screenings and had full term, live C-Section births.

These products are processed in accordance with standards established by FDA and American Association of Tissue Banks (AATB) to minimize potential risks of disease transmission to recipients.

 

Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493+. The products only come from a lab that is AATB accredited and Current Good Manufacturing Practices (cGMP) certified.

Benefits of HCT/P injections

  • Treat many chronic pain disorders (knee/shoulder/hip/joint pain, back pain, neuropathy, etc)
  • Promotes regenerative healing
  • Decreases chronic inflammation
  • Lubricates the joints
  • Very safe with minimal to no side effects
  • More growth factors then PRP injections

 

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