FAQs & PROCESS

Regenerative medicine is a therapeutic approach aimed at repairing and rejuvenating damaged musculoskeletal tissue, including tendons, ligaments, cartilage, and bone. Unlike traditional nonoperative pain management, which often serves as a temporary solution to mask pain, regenerative medicine seeks to go beyond a mere “band-aid” approach.
In instances where injuries lead to pain, traditional therapies like cortisone injections may not offer true healing potential. Regenerative medicine introduces a paradigm shift in patient therapy by focusing on facilitating tissue repair rather than providing temporary relief. The goal is to promote a more comprehensive healing process, moving away from the limitations of achieving only partial restoration to the native state of ligaments and tendons.
This innovative approach harnesses the power of substances, including stem cells, growth factors and platelets. These components act as building blocks, stimulating the body’s natural healing processes, and accelerating the overall recovery from injuries. By providing the essential elements needed for tissue repair, regenerative medicine aims to offer a more effective and long-lasting solution for musculoskeletal injuries.

Stem Cells are remarkable undifferentiated cells with the unique ability to transform into specific cell types as required by the body. This versatility is attributed to two key characteristics:
1-Self-Replication: Stem cells possess the capability to replicate themselves, ensuring a sustainable source for potential therapeutic applications.
2-Multilineage Differentiation: Stem cells can differentiate into a wide array of specialized cell types, encompassing bone, cartilage, muscle, nerves, and connective tissue. This transformative ability makes them invaluable in regenerative medicine.

Stem cells, functioning as progenitor cells, possess the remarkable ability to regenerate and differentiate into a diverse range of specialized cell types. The process unfolds in a series of steps once these stem cells are introduced into the body.
1. Injection and Signal Recognition: Upon injection, the stem keenly responds to inflammatory signals emitted by damaged tissues. This critical step serves as the initial trigger for their therapeutic action.
2. Mesenchymal Stem Cells (MSCs): Derived from the umbilical Cord, mesenchymal stem cells (MSCs) are recognized for their multipotent nature, allowing them to transform into various cell types with therapeutic potential.
3. Multifaceted Repair Mechanisms: Stem cells contribute to tissue repair through multiple avenues. Their actions include:
-Anti-inflammatory Activity: Stem cells exhibit anti-inflammatory properties, mitigating inflammation in damaged areas.
-Immune Modulating Capacity: They possess the ability modulate the immune response, fostering a balanced and controlled healing environment.
-Regenerative Stimulation: Stem Cells stimulate regeneration, actively participating in the restoration of damaged tissues.



High Throughput Screening Process

To ensure optimal therapeutic outcomes, a rigorous high throughput screening process is undertaken. This meticulous screening identifies stem cells with the highest:
-Anti-inflammatory Activity
-Immune Modulating Capacity
-Regenerative Stimulation Potential

We source our stem cells from Human Umbilical Cord Tissue, specifically utilizing adult stem cells with a rich concentration of Mesenchymal Stem Cells (MSCs). This choice is driven by the heightened efficacy of MSCs in their pivotal role in cellular signaling for tissue repair and regeneration.

Processing Journey:
1. Umbilical Cord Collection:

-The umbilical cord is collected in accordance with the stringent standards set by the American Association of Tissue Banks (AATB).
-Approximately four weeks before a scheduled cesarean section, the mother is given the option to either store or donate her unborn child’s umbilical cord. If she chooses donation, a thorough review of her medical and social history, along with a blood test, is conducted.
-Once the mother is deemed an acceptable donor, an experienced technician, during the cesarean section, clamps the umbilical cord and places it into a sterile collection bag.
2. Transport to Lab:
-The bag containing the umbilical cord is transported to the lab for processing.
3. Initial Testing:
-A sample of the umbilical cord tissue undergoes testing at a third part independent FDA registered lab. The testing, following United States Pharmacopeia rule 71 (U.S.P. 71), checks for known communicable diseases.
4. Stem Cell Processing:
-While disease testing is in progress, stem cells are processed, and red blood cell products are meticulously removed.
5. Sterility Testing:
-A sample of the finished stem cell product is sent to another third-party independent FDA registered lab for rigorous sterility testing.
6. Final Approval:
-Stem cells are only made available for distribution after receiving “clean” reports from both labs, ensuring they meet and surpass regulatory requirements.

Wharton’s jelly is a gelatinous connective tissue found surrounding and in between the vasculature of the umbilical cord. Its primary function is to cushion and protect the vasculature from mechanical stress (bending, kinking, torsion, etc.), thus protecting the nutrient flow from mother to fetus. The term “Wharton’s jelly” was coined by Thomas Wharton, a famous English physician in 1656, who was the first to describe it on record.
We utilize Vitacell Bio Global products. They are a premiere biologics laboratory based in Lewisburg, Tennessee, whose products are derived from donated human umbilical cords and are thoroughly tested for communicable diseases before and after processing. After processing, all products are stored in quarantine until testing results are received and the product is cleared for distribution.

Vitacell and Vitacell Pro Testing and Processing

Vitacell and Vitacell Pro are processed using the same methods with the only difference being concentration levels. These products are derived from human umbilical cords donated from consenting mothers. Donated tissue is acquired through an approved tissue acquisition company, which is then tested for communicable diseases before processing. During processing, red blood cells are removed and Wharton’s jelly tissue is disassociated from the umbilical cord and cut into small particulates of appropriate size to flow through a syringe. The disassociated tissue is then suspended in saline and placed into vials to be cryopreserved. We do not remove any of the original components, nor do we add any additional components save saline, which is expressly approved by the FDA. All products are placed under quarantine until testing results are received and the product is cleared for distribution.

Micro-vesicles (30-150nm) that are involved in cell communication. This is a new frontier in regenerative medicine. Exosomes have been recently discovered to be involved in direct cell signaling. Exosomes are isolated from donated human mesenchymal stem cells (MSCs) and purified using our proprietary processing. The unique benefit to these exosomes is that they are stem cell-derived and bring a wide array of growth factors to stimulate and modulate many processes within the healing cascade. Exosomes are not cells but are micro-vesicles, which are about 1/1000th the size of a cell and contain no nucleus or DNA. They can be regarded as the purest form of cellular therapy available, because their function is to direct tissue and wound healing by activating the patient’s own regenerative cell response. This is one of the latest generations of naturally bioactive stem cell-based products for patient treatment. Stem cells and stem cell therapy work by paracrine signaling (local cell-to-cell communication to induce changes in nearby cells) to create the appropriate healing environment to restore tissue. The exosomes are those paracrine signals isolated from stem cells that can be delivered without the need for delivering stem cells. As the technology and discovery of new methods of treating patients has evolved, the science shows that the optimal way to provide true “stem cell therapy” is to directly provide the signals as its own therapy and avoid potential issues with delivering and keeping transplanted cells alive. Stem cells by nature work to heal, repair, and restore the body. But, in some cases where there is a chronic abnormality, these cells fall into an inflammatory state, work in an unregulated capacity and inhibit healing. The 1000+ growth factor proteins found to naturally occur in healthy tissue have been shown to help modulate the inflammatory healing process. This is accomplished by activating and recruiting the patient’s “own cells” to the area, revascularizing the area and reducing the inflammatory response to allow natural healing.