In medicine today, regenerative therapies can be derived from four different sources: umbilical cord tissue, embryonic tissue, bone marrow, and adipose tissue. However, some sources have their drawbacks. Embryonic cells raise ethical concerns, while bone marrow and adipose tissue derived cells can only be retrieved through invasive surgical procedures. Umbilical cord tissue retrieval, which takes place immediately after the umbilical cord is cut upon delivery, is non-invasive and ethically sound. In addition to containing a wide variety cells, umbilical cord tissue is a source of growth factors that also play an important role in regenerative medicine.
The option to donate umbilical cord tissue is offered to expecting mothers by participating hospitals. Mothers who choose to donate undergo a screening and sign informed consent forms, indicating they consent to have their umbilical cord tissue used in medicine.
Umbilical cord tissue and blood extraction is conducted by a nurse immediately following delivery. Tissue is processed in a cGMP and GTP compliant laboratory.
BioGenix applies AATB regulatory standards to screen umbilical cord tissue for quality in our sterile FDA-compliant laboratory.
BioGenix distributes directly to doctors and healthcare institutions. Standardized concentrations allow physicians to accurately measure treatment dose. For purchasing information, please contact us.
This website is intended to inform and educate medical professionals. It is NOT intended for patients. It also 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 medical professionals about regenerative medicine, 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.
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