Human Cell and Tissue Biologics

What are Human Cell and Tissue Biologics (HCTB)?

Human Cell and Tissue Biologics are products used by holistic medical specialists to stimulate your body’s inherent ability to heal itself.  Products are regulated by the FDA under 21 CFR 1271 within the Center for Biologics Evaluation and Research department.  Products are considered human transplant tissues and regulated as biologics.

Regeneration-focused Treatment

Regeneration-focused Treatment is the use of human cell and tissue products to heal or regenerate cells, tissues and organs, and help restore normal function.  These products are considered safe since they are natural, unlike medications that can have serious side effects.  “Regenerative medicine may be defined as the process of replacing or regenerating human cells, tissues or organs to restore or establish normal function” –American Association of Blood Banks

Are there different types of Human Cell and Tissue Biologics (HCTBs)?

There are various products used in the HCTB field of medicine.   There are two sources of biologics, autologous (derived from you) and allogeneic (donated by someone else).

Autologous Sources:

  • PRP (platelet rich plasma)- PRP is the use of your own blood to help your body accelerate healing and repair.  First, a small amount of blood is drawn and then placed into a centrifuge to spine at a high rate.   Spinning separates your blood into layers, so we can isolate your platelets.  Platelets are rich with cytokines and growth factors, which help you heal.  Growth factors are signaling proteins that stimulate cell growth, differentiation, survival, inflammation, and tissue repair.  Cytokines are small proteins important in cell signaling, stimulating your immune system, and regulating the maturation, growth, and responsiveness of cells.

Typical Conditions PRP Can Help:

      1. Rotator cuffs
      2. Plantar fasciitis
      3. Tennis elbow
      4. Golfer’s elbow
      5. Muscle strain
      6. Tendonitis
      7. Mild cartilage damage
  • Bone Marrow- Extracting your bone marrow can be painful, however your bone marrow contains stem cells which help with healing and tissue regeneration.  Bone marrow transplants are used for decades, helping people with various cancers such as leukemia.   For personal use, to regenerative and repair damaged joint tissues, your own bone marrow cells are harvested with a surgical drilling technique, and then injected into your damaged joint for tissue repair and regeneration.
  • Adipose- Your adipose (body fat) contains regenerative cells which help with cell and tissue repair and healing.  Using a liposuction technique, your fat is extracted and either spun in centrifuge to isolate and harvest cells, and/or solvents added to your fat to isolate your own regenerative cells.

Allogeneic Products:

  • Exosomes- Exosomes are biological molecules responsible for communicating between our cells, telling the body to heal after damage or injury.  They are like messengers, making cells aware of problems in your body so that your body can respond.   1cc of umbilical cord tissue contains billions of exosomes.
  • Umbilical Cord Tissue- Human placental tissues are rich in regenerative cells and molecules.   Umbilical tissue helps the immune system, regeneration of damaged cells, tissues and organs, and reducing inflammation.  Of all the human cell and tissue biologics, umbilical cord tissue has the greatest capacity for healing and repair.

Typical Conditions Umbilical Cord Tissue Can Help:

    1. Cartilage damage or loss
    2. Ligament damage or tears
    3. Arthritis damage
    4. Labral tears, labrum damage
    5. Meniscal tears, meniscus damage
    6. Degeneration
    7. Neuropathy, sciatica, nerve damage
  • Umbilical Cord Blood- Varied stem cells such as hematopoietic (HSCs), mesenchymal (MSCs) and endothelial progenitor cells (EPCs) are found in umbilical cord blood.   Under FDA guidelines, cord blood would need to be used “tissue to tissue”, or blood to blood, and not used in joint tissues.

What are Stem Cells?

When a sperm fertilizes an egg, a zygote forms.  From the zygote, embryonic stem cells form.  Embryonic stem cells are “pluripotent”, meaning that these cells can give rise to any cell in our body.  The use of embryonic stem cells is illegal in the Unites States, and we believe unethical since harvesting these cells requires loss of life.   However, there are better way to harvest and use regenerative cells AFTER birth.

The process of a cell changing into a different type of cell is “differentiation”.  Embryonic stem cells (able to create ANY type of cell in the body) may create other stem cells such as Mesenchymal Stem Cells (MSCs) which are specified to differentiate into structural tissues such as bone, nerve, cartilage, muscle and tendon, and ligament.

How do HCTBs work?

Our bodies have an innate and powerful ability to heal.  We have trillions of cells, each living independent yet serving other cells, forming tissues, organs and systems.  Together, all these cells keep us alive.  When damage occurs to our cells or when cells die, our bodies heal the damage and safely remove the dead cells, replacing them with stem cell differentiation (the change of a general stem cell into a specific tissue cell).

Are They Safe?

Human cell and tissue biologics are very safe since they are substances natural in our bodies.  Placental tissues come from healthy women with informed consent and no women or baby is harmed or at risk from collecting the healing tissues.  The tissues and cells are regulated by the FDA under 21 CFR 1271 within the Center for Biologics Evaluation and Research department.  Additionally, Aligned Medical Group only uses product from Signature Biologics who abides by the American Association of Tissue Banks, Current Good Manufacturing Practice, Current Good Tissue Practice and International Organization for Standardization.

What Conditions May Benefit from Human Cell and Tissue Biologics?

  • Nerve damage, nerve pain
  • Peripheral neuropathy
  • Cartilage damage
  • Damaged, torn ligaments and tendons
  • Muscle strains and tears
  • Rotator cuff tears
  • Plantar fasciitis
  • Tennis elbow
  • Meniscus and labral tears
  • Scar tissue and adhesions

Are They Covered by Insurance?

There are no insurances covering human cell and tissue biologics for orthopedic use as of October, 2021.  Pricing varies, depending on which type (or types) are used.  Our office provides various financing options and more patient are able to afford our regenerative services.

 

If you are dealing with chronic pain, HCTBs can help you find relief. Call Aligned Medical Group today at
(610) 644-3166 to learn more about the HCTB services we offer.