Regenerative therapy is a cellular-level therapy that aims to improve the function of damaged or diseased tissue or organs by introducing cells to replace or repair damaged cells. Today, regenerative therapies are being recognized for their therapeutic potential for a wide variety of medical conditions across a range of specialties, including orthopedics, rheumatology, cardiology, neurology, immunology, and much more.

Because of their ability to differentiate into cells that carry out the roles needed in a variety of bodily functions; cellular allografts are an essential regenerative tool. When these allografts are introduced into damaged tissue or organ, they have the ability to evolve and carry out necessary functions, repairing or compensating for the damaged cells. As a minimally invasive process, regenerative therapy harnesses the natural capabilities of regenerative allografts and the body’s own ability to heal, providing an opportunity to avoid painful and invasive procedures.

Our exosome product is in a safe, ultra pure lyophilized form—-this process is the least vulnerable to contamination. Lyophilization also allows the user to resuspend the exosomes in the volume of normal saline needed for the specific application.  Our exosome powder can be transported and stored with greater ease then liquid suspensions.  Our lyophilized exosomes can be stored safely at -20 C and can be refrigerated after reconstitution in normal saline for up to 4 days.

Cell allografts, that occur naturally in the body, are “naive” or unspecialized. This means that, based on cues from their environment, these cells have the ability to transform into and assume the functions of a variety of different cells and cell types in the body. The ability to mature in a context-specific way is the key to the vast potential of cells in regenerative therapies. When introduced into damaged tissue, the cells can specialize and carry out their necessary functions in that particular area, potentially improving symptoms and function.

While regenerative cells are found throughout the body, the cells used in medicine today may be derived from four different sources: umbilical cord tissue, embryonic tissue, bone marrow aspirate, and adipose tissue. However, some sources have their drawbacks. Embryonic cells raise ethical concerns, while bone marrow and adipose tissue-derived products can only be retrieved through invasive surgical procedures and have a significantly lower yield.

Considering this, BioGenix uses exclusively umbilical cord-derived products. Umbilical cord tissue retrieval, which takes place immediately after the umbilical cord is cut upon delivery, is non-invasive and ethically sound. In addition, umbilical cord tissue products have the highest product yield and are the best source of growth factors and cytokines that have an important role in regenerative therapies.

Allogenic umbilical cord MSC have shown promising results for support and repair of:

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1. Neurodegeneration Repair

2. Heart and Angiogenesis

3. Cartilage and Intervertebral discs

4. Osteoarthritis and Joints

5. Abnormal immune responses and joints in juvenile idiopathic arthritis patients and rheumatoid arthritis

6. Bone and nonunion bone abnormalities

7. Organ regeneration (kidney, liver, heart, etc.)

And….much more

Compliant with FDA Current Good Manufacturing Practice (CGMP) and FDA Good Tissue Practice (GTP)

Produced in sterile FDA compliant laboratory

Processed with the highest safety, testing and quality control

Participating hospitals invite mothers expecting normal, healthy births to donate the resulting umbilical cord. This tissue was once disposed of as waste, but is now considered to be an excellent source of high-quality stem cells.

At the time of birth, a specialized nurse enters the delivery room to carry out the extraction procedures.

With the mother’s informed consent, the umbilical cord is clamped off when the baby is born.

The byproduct is then extracted from the cord and taken to our sterile lab, which then processes the cell allograft for therapeutic use.

Our lab specialists screen the cords under AATB standards and process the byproduct to extract the stem cells.

Unlike other regenerative medicine companies, we extract our units in standardized concentrations for accurate and consistent treatment doses

We ship in single-dose preparations on dry ice for maximum preservation

Disclaimer:

This information is intended to inform and educate. It does not seek to make claims about the effectiveness of regenerative medicine and its respective therapies in medical treatment.

Regenerative therapies have great potential in helping treat a range of conditions. This site serves to inform about regenerative medicine, and BioGenix allograft products, and key in vitro, animal model, and clinical research studies that have been carried out to date across medical specialties and health conditions.

However, regenerative medicine is an early and evolving field, and clinical studies are still insufficient to determine effectiveness.

While the BioGenix products are produced in an FDA compliant laboratory, it has not been approved by the FDA for treatment effectiveness. The FDA states:

“Like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood-forming stem cells) for certain indications.”

Patients interested in regenerative therapy in the U.S. are advised to consult a physician about the state of FDA approval for any given product and/or inquire about opportunities to participate in a clinical trial. Patients interested in regenerative therapies outside the U.S. should investigate regulations in the specific country. It is important to be aware that regulations and clinical study requirements vary from country to country.